Yourlawyer.com (Chantix News)

Chantix Lawsuit Blames Drug for 2007 Death of Dallas Musician

Tue, 08 Sep 2009 00:00:00 -0700

The parents of Carter Albrecht, a Dallas musician who was shot to death during a bizarre episode that was allegedly fueled by Chantix side effects, have filed suit against Pfizer, Inc. According to a CBS 11 report, the lawsuit claims Pfizer did not disclose the risks of Chantix or provide adequate warning of possible side effects when Albrecht began taking it in an effort to quit smoking.

Albrecht's death occurred in September 2007, just a week after he began taking Chantix. Shortly after beginning Chantix therapy, Albrecht began complaining of vivid dreams. According to a Dallas Morning News article published after his death, Albrecht had lashed out violently towards his girlfriend on the night he died – something she said had never occurred before. Albrecht’s girlfriend told the Morning News that he seemed confused and terrified, and looked at her as though he did not recognize her. Somehow, Albrecht ended up at the home of a neighbor, banging violently on the back door. A call was made to 911, but before the police arrived the terrified neighbor had fired a warning shot from his rifle, which accidentally hit and killed Albrecht.

In their lawsuit, Albrecht's parents allege that their son's use of Chantix played a "direct and proximate" role in his death. According to the Dallas Observer, the Albrecht's are hoping that by filing the lawsuit, they will "remind Pfizer they have to keep the public informed of the risks associated with this drug."

Albrecht's parents also acknowledge that Pfizer's attorneys will likely make an issue of their son's alcohol use (his blood alcohol level was three times over the legal driving limit) on the night of his death. According to the Observer, they are ready for that fight, and want to see their lawsuit go to trial. They insist that Albrecht's death was the result of vivid dreams, hallucinations and behavioral changes that had been caused by Chantix.

In July, the Food & Drug Administration (FDA) mandated that its most serious safety warning - a Black Box - regarding psychiatric side effects be included on the Chantix label. According to The Washington Post, the FDA said psychiatric side effects seen among Chantix users included 98 reports of suicide and 188 reports of attempted suicide. While some of the psychiatric problems reported could have been the result of nicotine withdrawal, the FDA noted that many problems occurred while Chantix users were still smoking.

Chantix's association with psychiatric problems has spawned scores of product liability lawsuits similar to the one filed by the Albrecht family. The U.S. Judicial Panel on Multidistrict Litigation has scheduled a hearing for September 24 to determine whether all federal Chantix lawsuits should be consolidated and centralized in one district as a Multidistrict Litigation.

Chantix, Zyban Get Black Box on Mental Health Issues

Wed, 01 Jul 2009 00:00:00 -0700

Labeling for Chantix and Zyban will be updated to include a Black Box Warning regarding their link to mental health events, including changes in behavior, depressed mood, hostility, and suicidal thoughts. A Black Box Warning is the Food & Drug Administration's (FDA) most serious safety notice.

It should be of no surprise to readers of this blog that Chantix is getting such a serious safety warning, as its problems are well-documented. The FDA actually began investigating its link to psychiatric side effects in late 2007. In 2008, Chantix maker Pfizer elevated the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with a Black Box warning.

The FDA said today that new Black Box Warning for Chantix and Zyban was based on a review of reports submitted to the agency’s Adverse Event Reporting System since the time the products were marketed and on an analysis of information from clinical trials and scientific literature. According to a report in The Washington Post, the FDA had received 98 reports of suicide among patients taking Chantix and 188 reports of attempted suicide, and 14 suicides and 17 suicide attempts among patients taking Zyban.

In many cases, the FDA said the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped. The agency also said that some of the problems could have been the result of nicotine withdrawal, however many of the reported events occurred while patients were still smoking.

Zyban, manufactured by GlaxoSmithKline, was originally marketed as an antidepressant under the name Wellbutrin. In 1997, the FDA approved Zyban to be used as a quit smoking aid. In today's announcement, the FDA said similar information on mental health events will be required for Wellbutrin and its generic equivalents. These drugs already carry a Black Box Warning for suicidal behavior in treating psychiatric disorders.

The FDA said health care professionals who prescribe Chantix and Zyban should monitor their patients for any unusual changes in mood or behavior after starting these drugs. Patients should immediately contact their health care professional if they experience such changes.

Chantix Among Drugs Being Reviewed by FDA

Fri, 05 Jun 2009 00:00:00 -0700

The anti-smoking drug Chantix is among 20 medications currently undergoing a Food & Drug Administration (FDA) safety review. According to Reuters, Chantix was included on a list of such drugs released by the FDA yesterday. Other drugs on the list include Provigil, which is used to treat sleep disorders; the weight-loss drug orlistat; and Detrol, a drug used to treat overactive bladder.

The list, which the FDA issues on a quarterly basis, is part of the agency's ongoing effort to inform the public about early investigations of potential side effects that have been reported, Reuters said.

It should be of no surprise to readers of this blog that Chantix made the FDA's list, as its safety problems are well-documented. In 2008, Chantix maker Pfizer elevated the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with a black box warning - the agency’s highest safety alert.

The FDA is now reviewing Chantix for a possible association with accidental injury, vision impairment and other issues. According to Reuters, the Chantix review was prompted by reports of accidents, vision loss and other problems in hundreds of patients.

The FDA's latest safety review comes on the heels of a report published last year by the Institute for Safe Medicine Practices, which found that the FDA received 1001 reports of serious adverse events associated with Chantix in the first three months of 2008. According to the report, the only other drug that even came close to matching Chantix during the same period was heparin which was the subject of a recall earlier that year. According to the Institute, the Chantix side effect reports included 50 deaths, 52 cases that may have involved various kinds of blackouts, and 15 adverse events that were linked to road traffic accidents.

According to Reuters, other drugs on the list include:

Orlistat (sold as the prescription drug Xenical, and over-the-counter as Alli) for a risk of liver injury;
Nuvigil and Provigil for serious skin reactions that were identified as an issue with the drugs in 2007;
Detrol for reports of Stevens-Johnson syndrome, a serious skin reaction;
HIV drug, Sustiva due to one report of an eye-related birth defect;
The contraceptive Yasmin, for a possible risk of pancreatitis.

Chantix Ads Questioned

Thu, 19 Feb 2009 00:00:00 -0800

A direct-to-consumer (DTC) drug ad is raising some controversy over marketing of a medication that has long been surrounded with debate. Consumer Reports is questioning the ethics of a Chantix (varenicline) ad that, while never mentioning the drug by name, appears to be marketing the medication while seeming to be a public service announcement.

The commercial focuses on a Website dedicated to smoking cessation entitled MyTimeToQuit.com and presents information in a public service format, says Consumer Reports, pointing out that it is only at the end of the commercial that hints about the ad’s origin are discreetly revealed. The ad indicates, in the final moments, that it is sponsored by Pfizer, which is the maker of Chantix. Also, the MyTimeToQuit Website leads viewers to the Chantix Website.

Consumer Reports notes that the methods, while “sneaky,” are legal and point to a trend in which such DTC ads are leaning more toward so-called “help-seeking” ads. These ads, says Consumer Reports, do not mention the drug being marketed, but, rather, discuss the treatment for which the drug is approved, sending viewers to a Website or toll-free telephone number. The next step—the initial Website or toll-free number—provides more information that includes learning about a “prescription treatment option.” Consumer Reports noted that www.FibroCenter.com and www.PsoriasisConnect.com are both such types of pharmaceutical industry-sponsored Websites that lead consumers to information on prescription drugs.

This emerging type of advertising is effective when industry is looking to market a medication that has extensive or dangerous side effects because if the drug’s name is not mentioned, the advertiser is not mandated to disclose its side effects, according to the U.S. Food and Drug Administration (FDA), said Consumer Reports.

Chantix, a smoking cessation medication marketed by Pfizer, Inc., was approved by the FDA in 2006. Chantix side effects may include suicidal thoughts, depression, and even violent behavior. In September 2007, Chantix side effects were implicated in the bizarre death of a Dallas, Texas man, among other horrible stories.

A number of adverse event reports were made to the FDA following Chantix’s release to the market such as “serious neuropsychiatric symptoms,” including “changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide” said Consumer Reports. The reactions prompted a drug label update last year to include warnings about potential psychiatric side effects associated with Chantix use.

One of the problems with the release of Chantix is that Pfizer conducted studies on the medication, but did not include people with a history of depression, bipolar disorder, or serious mental illness, all of which include heavy smokers and for whom Chantix might pose serious risks. Some believe, said Consumer Reports, that because Chantix affects some brain processes and because some high-risk groups were not included in testing, the adverse events were not revealed until after the drug received FDA approval.

Consumer Reports warns that when approached with public service-like advertising, to determine from where it is sponsored and be aware that if the information is sponsored by the pharmaceutical industry, the goal of the information is to sell drugs. Also, be aware of options on such sites requesting information on personal stories, which require patient release and enable release of the entire story for marketing purposes.

Chantix Problems in Britain

Fri, 28 Nov 2008 00:00:00 -0800

The controversial smoking cessation drug known as Chantix in the U.S., was introduced by Pfizer as Champix nearly two years ago in Great Britain. The drug is known generically as varenicline in both countries and, in Great Britain, about 400,000 prescriptions have been written says BBC News’ online site. Internationally, says the BBC, about nine million prescriptions have been written.

The BBC explains that Chantix is a nicotine-mimicking drug that enables the body to reduce its urge for cigarettes while also reducing its withdrawal symptoms. However, in studies, the drug did not provide increased efficacy over other methods of smoking cessation. Despite this, notes the BBC, Pfizer earned over $883 million from the drug in its first year.

In addition to not offering better results over other alternatives, Chantix has been associated with unusual and sometimes dangerous side effects. The BBC piece discussed a woman who attempted suicide days after beginning the drug and a man who succeeded in killing himself while on Champix. Interestingly, in the suicide case, the coroner was unable to rule the death a suicide because the drug was in the victim’s bloodstream and the physician was aware of its links to suicidal ideation, noted the BBC. In Britain, according to the piece, over 3,000 people have “complained about adverse reactions to Champix,” with nearly 200 reporting suicidal reactions, 16 attempting suicide and 10 succeeding in committing suicide.

The BBC investigation led to similar findings in the U.S. with one man creating a night-long scene of fighting with his girlfriend and with a handgun, causing an armed, police stand-off. All this occurred after the man, an Iraq vet with post-traumatic stress, had taken Chantix for only a few days. Veterans Affairs prescribed the drug as part of a study and, in that case, a Congressional investigation ensued in which the victim noted that the problem originated with Chantix, according to the BBC.

The BBC also discussed a father of three who killed himself with a shotgun to his mouth, another man who killed himself with a shot to the head, and a mother who hanged herself. All three were on the drug and none had prior psychiatric history.

As we recently reported, Chantix was linked to 10 suicides in the UK, based on information from that country’s health regulators, representing the first time officials at the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) revealed the link between Chantix and suicide there. Earlier this year, the U.S. Food & Drug Administration (FDA) said it linked 37 suicides to Chantix.

Meanwhile, MedPageToday.com, also reported that Chantix has been linked with over 1,000 adverse events that include 50 deaths, in the first quarter of this year alone. The Institute for Safe Medication Practices reported that this figure now places Chantix at the “top of its list of drugs associated with serious injuries during the quarter.”

Since its approval in 2006, Chantix has been associated with 3,325 reported serious injuries in this country that include 112 deaths, the institute said, according to MedPageToday.com. Because the FDA’s post-market surveillance system is voluntary, the report may be underestimating actual figures.

British Regulators Report 10 Chantix Suicides

Mon, 10 Nov 2008 00:00:00 -0800

Chantix has been linked to 10 suicides in the United Kingdom, according to that country's health regulators. This is the first time officials at the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) have revealed the link between Chantix and suicide in that country. Earlier this year, the U.S. Food & Drug Administration (FDA) said it had linked 37 suicides to Chantix.

Chantix, approved in both the US and Britain in 2006, works by blocking nicotine receptors to the brain. Chantix was the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.

But the drug has been the subject of disturbing side effect reports. In November 2007, the FDA issued an “Early Communication” that stated its preliminary assessment revealed many reports of suicidal behavior it had received in relation to the drug reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.

Just last month, a report issued by the non-profit Institute for Safe Medication Practices found that in the first quarter of 2008, the FDA received more serious side effect reports for Chantix than for any other medication. According to the Institute, the Chantix side effects reported in that time frame included 50 deaths, 52 cases that may have involved various kinds of blackouts, and 15 adverse events that were linked to road traffic accidents.

Earlier this year all pilots and air traffic controllers in the US were banned from taking Chantix because of fears about potential side effects.

In the UK, where Pfizer sells Chantix under the name Champix, the MHRA website says a total of 24 people taking the medication have died, and of those, 10 were suicides. A further 213 claimed they had experienced suicidal thoughts and 407 said they were suffering depression.

The MHRA also says the number of users reporting adverse side effects while using Chantix has doubled in the past seven months – up from 1,811 in February to 3,541 in September. The British health watchdog is now warning doctors and nurses to monitor the effects of the drug on smokers over the New Year, when many will try to kick the habit.

Last December, the European Medicines Agency ruled that the inserts in boxes of Chantix be updated to include warnings about suicide and depression.

Group Says Drug Injury, Death Reports Up Sharply

Mon, 03 Nov 2008 00:00:00 -0800

Reports of drug adverse events, including deaths, increased sharply in the first quarter of the 2008, a new report says. According to the Institute for Safe Medication Practices, the non-profit research group which compiled the report, much of the increase was due to side effects from the anti-smoking drug Chantix, as well as tainted heparin. However, the narcotic pain reliever Oxycodone, the anti-anxiety medication Alprazolam (sold under the brand names Xanax, Reclam and Niravam) and Acetaminophen had the highest number of death reports in the same time period.

The Institute compiled its quarterly report from an analysis of new adverse drug event reports submitted to the Food & Drug Administration (FDA) Adverse Event Reporting System. However, this reporting is voluntary, and only a small fraction of adverse drug events that occur are ever reported to FDA, or to drug manufacturers which then investigate and forward reports to the agency. The Institute's statement on its report also cautioned that, while the sum of adverse event reports normally provides an overall adverse event profile for a drug, the individual reports themselves do not prove that the drug caused the event described.

According to the Institute's latest quarterly report, adverse drug reactions and deaths hit record numbers in the first quarter of 2008. According to the report, there were:

20,745 new cases of serious injuries were reported, which is 38% higher than the average for the previous four quarters, and the highest for any quarter yet reported in a calendar quarter since 2006.
4,824 drug-related deaths were reported, a 2.6-fold increase from the previous quarter and the highest number of deaths yet reported since 2006. Fatal cases also accounted for a larger share of all serious cases: 23% of those in the first quarter of 2008 compared to a historical average of 16%.
1,464 (7.1%) of all cases of serious injuries were attributed to identifiable medication errors.

For the second straight quarter, Chantix accounted for more reported serious injuries than any other prescription drug, with a total of 1,001 new cases including 50 deaths. That number included numerous cases that involved vehicular or other accidents, or syncope with a high potential to cause accidents, the Institute says. Chantix has also been the subject of an FDA safety review involving psychiatric side effects, including suicidal behavior.

Ranked second in reported serious injuries was heparin, the subject of a major product recall after a potentially lethal contaminant was identified and traced to suppliers in China. In the first quarter of 2008, the FDA received 779 reports of serious injury in which heparin was the principal suspect drug, including 102 deaths.

Most strikingly, the Institute found that 10 different drugs this quarter could be linked to 100 or more deaths while in the previous 2 years, only 1-3 drugs accounted for 100 or more deaths. The risks of many of these drugs, like Oxycodone, Alprazolam and others, have been the subject of previous safety warnings from the FDA and the Institute.

Two drugs linked to 100 or more deaths, acetaminophen (160 reported deaths) and ibuprofen (114 reported deaths), are among the most widely used drugs in the nation. While both acetaminophen and ibuprofen have well-characterized safety profiles, the Institutes press release pointed out that an overdose of acetaminophen can result in irreversible injury to the liver and death. Ibuprofen carries warnings that sustained use can result in serious gastrointestinal side effects, and some may increase the risk of heart attack

Finally, the Institute also said it had investigated a surge in reported deaths associated with Fiorcet, a generic drug combination product containing acetaminophen, butalbital, and caffeine that is used to treat tension headaches. But the Institute determined that these reports did not indicate a safety problem, and instead were attributable to questionable coding of a published statistical report summarizing cases reported to the country’s poison control centers in 2006.

Chantix Under Review by FDA After Traffic Accident Report

Fri, 24 Oct 2008 00:00:00 -0700

Reports of traffic accidents by users have prompted federal regulators to take another look at the safety information on the Chantix label. Word of the latest Food & Drug Administration (FDA) review comes just days after a non-profit drug research group released a report that found, in the first quarter of 2008, the FDA received more serious side effect reports for Chantix than for any other medication.

According to the report issued Tuesday by the Institute for Safe Medicine Practices, the FDA received 1001 reports of serious adverse events associated with Chantix in the first three months of this year. The only other drug that even came close to matching Chantix during the same period was heparin (779 side effect reports, including 238 possible deaths), which was the subject of a drug contamination scandal earlier this year.

According to the Institute, the Chantix side effect reports included 50 deaths, 52 cases that may have involved various kinds of blackouts, and 15 adverse events that were linked to road traffic accidents.

This was the second report on Chantix side effects the Institute has issued this year. In May, researchers there reported that Chantix had been the subject of 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. At that time, there were also reports of a dozen traffic accidents linked to Chantix.

According to Reuters, the accident reports are being reviewed by the FDA. "FDA confirms that there are reports of accidents, including road traffic accidents, after the use of varenicline in the Adverse Event Reporting System. The FDA is reviewing these reports to see if current labeling related to accidents after varenicline is adequate," an FDA spokesperson told Reuters via email.

The FDA has already reviewed Chantix for a possible link to suicide and suicidal behavior. In February, the agency asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.

Following the May report from the Institute for Safe Medicine Practices, several government agencies, including the Department of Transportation, the Federal Aviation Administration and the Department of Defense issued rules restricting the use of Chantix.

Serious Drug Reaction Reports Reach A Record High Due to Heparin and Chantix

Thu, 23 Oct 2008 00:00:00 -0700

The Associated Press (AP) is saying that the number of adverse effects, including deaths, linked to medications reported to the government has set a record in the first three months of this year; this according to a health industry watchdog group. It seems, according to the AP, that the U.S. Food and Drug Administration (FDA) “received nearly 21,000 reports of serious drug reactions, including over 4,800 deaths.” The FDA data was derived from an analysis of federal data by the nonprofit Institute for Safe Medication Practices (ISMP), which reviewed data as far back as the 1990s.

Two drugs accounted for what the AP termed a “disproportionately large share of the latest reports.” One drug was heparin, the tainted blood thinner from China that caused an international safety scandal that, according to the ISMP study, accounted for 779 reports of serious problems, including 102 deaths. The FDA, which relies on data spanning a longer time frame, reports 238 deaths possibly linked to heparin.

The other drug was Chantix, a new anti-smoking drug from Pfizer that has been blamed for a number of unusual and dangerous reactions and works in the brain to both ease withdrawal symptoms and block the pleasurable effects of nicotine when a smoker attempts to light up. Chantix received the most reports of any medication. The FDA should forcefully warn patients taking Chantix that they might suffer blackouts and other problems that could lead to accidents, the report said. The report found 15 cases of traffic accidents, and 52 additional cases involving blackouts or loss of consciousness in Chantix patients; the FDA received 1,001 reports of serious injuries, possibly linked to Chantix, represnting more than for the ten best-selling brand name drugs combined.

Chantix "continued to provide a striking signal of safety issues that require investigation and action," the report said. Meanwhile, we have long been reporting on the bizarre reactions Chantix users have been experiencing and, earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. Although the government has banned Chantix for pilots, Pfizer said yesterday "We stand by the efficacy and safety profile of Chantix."

The FDA had no immediate response to the report, but defines serious drug reactions as ones that cause hospitalization, require medical intervention, or place a life in jeopardy; its monitoring system relies on voluntary reports from doctors. Many believe the system only captures a small percentage of actual cases.

The report also stated that the 20,745 cases reported from January-March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, said the AP. Twenty-three percent—4,824—ended in death, a nearly three percent increase from the last calendar quarter of 2007. Previous ISMP research revealed that serious drug safety problems reported to the FDA increased significantly from 1998-2005.

“FDA case reports provide a signal of possible problems with a drug, but a cause-and-effect connection can only be established through painstaking investigation,” reported the AP. For instance, if “the FDA were a police agency, the reports would indicate ‘probable cause,’ but not necessarily ‘guilt beyond a reasonable doubt,’” the AP pointed out. As far as Chantix is concerned, many feel that reasonable doubt has been met.

Reports of Chantix Side Effects, Deaths Mounting

Wed, 22 Oct 2008 00:00:00 -0700

A non-profit drug research organization said today that, in the first quarter of 2008, the smoking cessation drug Chantix was the subject of more serious side effect reports than any other medication currently on the market. According to the Institute for Safe Medication Practices, during that time period, the Food & Drug Administration (FDA) received 1001 adverse event reports - including deaths - in regards to Chantix. Researchers at the Institute said Chantix needs to carry stronger warnings about its potential risks of accidental injury and death.

Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the Food & Drug Administration (FDA). It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.

But the drug has been the subject of disturbing side effect reports. In the US, Chantix has been linked to suicides and attempted suicides. In November 2007, the FDA issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.

Today's Institute for Safe Medication Practices report said that for the first three months of 2008, Chantix had been linked to 50 deaths, 52 cases that may have involved various kinds of blackouts, and 15 adverse events that were linked to road traffic accidents.

This is not the first time that the Institute has taken aim at Chantix. In May, researchers there reported that Chantix had been the subject of 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. At that time, there were also reports of a dozen traffic accidents linked to Chantix.

After the May report was released, several government agencies, including the Department of Transportation, the Federal Aviation Administration and the Department of Defense all restricted the use of Chantix. Pilots and air-traffic controllers were told to stop using Chantix immediately.

This latest Institute report comes at a difficult time for Pfizer, the maker of Chantix, which has been trying to counter the drug's bad publicity. It was only last month that Pfizer resumed running new ads on TV that mention Chantix by name. The company had ceased such spots last year, as concerns over Chantix side effects mounted. Since then, sales of the drug have fallen off.

Pfizer is undoubtedly desperate to salvage Chantix, as it was counting on the drug to become one of its major growth drivers. Pfizer had touted Chantix as a product that could help offset $12 billion in sales that the company’s Lipitor cholesterol medicine will begin losing to generic competition in 2010.

Review of VA Chantix Study Shows Agency Failed Vets

Wed, 24 Sep 2008 00:00:00 -0700

A review of a Chantix study conducted in cooperation with the Department of Veterans Affairs (VA) has found that the VA was responsible for numerous "unacceptable failures" in ensuring safeguards for soldiers in the experiment. The Chantix study used veterans suffering from post traumatic stress disorder (PTSD) as test subject.

In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling.

Over the summer, ABC News, in conjunction with The Washington Times, aired an investigative report which revealed that veterans enrolled in a Chantix clinical trial - all diagnosed with PTSD - had not been told that the drug was linked to depression, suicide and psychotic behavior. Even after the FDA issued its Chantix Early Communication in November, the VA did not notify study participants of its association with suicide. It wasn’t until the FDA issued its second warning, and Pfizer sent out its own alert, that the VA acted. But even then, the VA’s notice didn’t specifically mention suicide.

The ABC News/Washington Times report sparked an outcry, and Congress ordered the VA to conduct an internal review of the Chantix study. The review, which was released Friday by the VA's Office of Research Oversight (ORO), points out that Chantix was "newly approved by the FDA for smoking cessation when it became available for use by [the study's] participants, and it had not been formally evaluated in a comparable study population."

The review found that no system was in place to warn veterans when the FDA issues new warnings that drugs they are taking might cause serious side effects. Researchers responsible for the study first failed to notify internal review boards that oversaw the experiment when the FDA first publicized its concerns in November. When a second warning was issued in February, it took 16 to 134 days to alert veterans.

The review also found monitoring of the studies at 10 different sites to be an "unacceptable failure" and that review boards did not investigate some 26 "serious adverse events" that some participants experienced.

Despite the problems with VA Chantix study, it is still ongoing. As of Feb. 1, when the FDA issued its warning, 120 participants were still taking Chantix. All except 27 have signed an addendum referencing the newest warnings and nine have dropped out of the study, the VA said.

Chantix TV Ads To Start Airing Again

Fri, 12 Sep 2008 00:00:00 -0700

Chantix maker Pfizer is planning to start running TV spots for the drug again this weekend, obviously hoping that furor over its possible link to suicidal behavior has died down. Pfizer pulled Chantix TV commercials last year, as concerns over suicide and other side effects grew. One Pfizer executive told Forbes.com that since the ads stopped running, some consumers have been under the impression that Chantix had actually been taken off of the market.

Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the Food & Drug Administration (FDA). It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. Some analysts had estimated that Chantix sales could reach $2.28 billion by 2012.

But the drug has been the subject of disturbing side effect reports. In the US, Chantix has been linked to dozens of suicides and hundreds of attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.

In May, the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the FDA. The report, which was released in May, specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of a dozen traffic accidents linked to Chantix.

According to Forbes.com, the new Chantix ads, which begin running on Sunday, feature the same "tortoise and the hare" theme Pfizer used before it stopped advertising the drug. The longer spots now run for 90 seconds, and roughly 41 seconds involve side effect information. About half of that time is devoted to warning that patients taking Chantix should stop taking it if they experience agitation, suicidal thoughts or suicidal behavior. Pfizer says the role of Chantix in those symptoms is "not known."

It is not unusual for drug makers to rework ads after a safety controversy has erupted. While one expert interviewed by Forbes said she was glad the new Chantix ads will include specific side effect information, she is withholding judgment until she actually sees the spot. "It is good news if the serious risks are now present physically," Ruth Day, of Medical Cognition Laboratory at Duke University, said. "But are they there functionally--in a way that people will understand and remember them?"

Chantix Ad Campaign Doesn't Name Names, Leaves Out Side Effect Info

Fri, 29 Aug 2008 00:00:00 -0700

Chantix maker Pfizer Inc. has hit upon an unusual marketing strategy for the smoking cessation drug - running ads that never even name the drug. According to The Wall Street Journal, such "unbranded product advertising" is becoming increasingly common in pharmaceutical marketing. These types of promotions are growing in popularity because there is no requirement that they include important safety information consumers should know.

Anyone who watches television has seen Pfizer's ad for Chantix, although they might not know it. In the spot, a middle-age woman tells the camera, "At 6:30 in the morning, I have a cigarette. And then another on my way to work." Viewers are then directed to Mytimetoquit.com, where they can receive information on smoking cessation. Visitors to the site find a link to a Chantix site that contains information on the antismoking drug, including the negative side effects.

Pfizer is not alone in using this type of advertising. SonofiAventis has been running a compelling TV spot that leads viewers to a Web site called silenceyourrooster.com. The site promotes Ambien, a sleeping aid sold by the company.

Drug companies like these ads because the Food & Drug Administration (FDA) does not require that they list safety information like side effects. Advertisements that mention a medication by name must include the reading of possible side effect. Drug company marketing execs claim that reading off side effects takes up too much time in an expensive 30 or 60 second spot. But when a drug is the subject of safety concerns, these rules can make unbranded advertising an even more attractive option for pharmaceutical companies.

According to The Wall Street Journal, Pfizer first aired the "My Time to Quit" ads in 2006, shortly after it came on the market. But as Chantix sales rose, the company started running ads that mentioned the drug by name, and dropped the unbranded campaign.

That only changed a few months ago. Pfizer resurrected "My Time to Quit" in June, after concerns were raised over Chantix side effects. The move came after the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the FDA. The report, which was released in May, specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of a dozen traffic accidents linked to Chantix.

The Institute's report followed two FDA safety alerts - one in November 2007 and another in February 2008 - that warned Chantix had been associated with suicidal thoughts and other psychiatric side effects. At the time of the February alert, the FDA asked Pfizer to elevate the prominence of safety information regarding such side effects to the warnings and precautions section of the Chantix prescribing information, or labeling.

Some consumer advocates believe that leaving out safety information misleads consumers. Drug companies counter that they are only trying to increase awareness of a disease or treatment, not push a particular medication. The increasing use of unbranded drug ads will doubtless fuel the debate, and that could get the attention of lawmakers. Bob Ehrlich of DTC Perspectives, which monitors direct to consumer advertising by drug makers, told The Wall Street Journal that while the ads are clever, "There's a risk they could rouse congressional ire over cute commercials that don't emphasize medicine."

Chantix Out at One U.S. Military Base

Mon, 11 Aug 2008 00:00:00 -0700

A U.S. military pharmacy has decided that it will not carry Chantix, the Pfizer anti-smoking drug that has been linked to suicidal behavior. Medical officials at Yokota Air Base in Japan were concerned enough with the drug’s potential safety risks that they voted recently to remove Chantix from the base pharmacy.

In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.

The decision to remove Chantix from the pharmacy at the Yokata Air Base was made after the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the FDA. The report, which was released in May, specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of a dozen traffic accidents linked to Chantix.

The report noted that in the fourth quarter of 2007, Chantix accounted for 988 serious injuries in the U.S. reported to the FDA, more than any other individual drug in this time period.

Two days after the institute’s report, the Defense Department’s Office of the Chief Medical Officer recommended that Chantix "should not be used by personnel operating aircraft (including aircrew and air traffic controllers) and missile crew members."

According to the "Stars and Stripes" website, no Chantix patients at Yakota have reported any adverse reactions. A patient with approval from his doctor can opt to continue the medication, and special order the drug. In the meantime, Yokota has suspended all refills of Chantix until patients review with their health care provider the potential risks and benefits of continuing the drug.

Since Chantix was approved by the FDA in 2006, the number of military prescriptions for the drug has exploded. In 2006, only 262 Chantix prescription were written at U.S. military medical facilities. By 2007, that number had jumped to 67,580,

First Chantix Lawsuit Filed

Fri, 11 Jul 2008 00:00:00 -0700

One of the first lawsuits over Pfizer’s smoking cessation drug, Chantix, is becoming official this week. The lawsuit alleges that the use of Chantix led David Collins of Gas City, Indiana, to commit suicide in January and that Pfizer failed to issue proper warnings about psychiatric side effects. Collins’ widow, Linda, filed the suit Tuesday in a U.S. District Court in Indianapolis. According to the lawsuit, Collins began using Chantix in October 2007. Linda’s lawyer claims David had no history of psychiatric problems.

The lawsuit alleges that Pfizer purposely excluded people with a history of mental illness when it tested Chantix during clinical trials. ”I run a clinic, and two out of three (smokers) I see have psychiatric or mood problems,” Dr. Daniel Seidman, director of Smoking Cessation Services at Columbia University Medical Center, is quoted in the suit. The suit also alleges the active ingredient in Chantix was derived from cytosine. Cytosine has been linked to suicide and the suit alleges Pfizer should have known about that link based on documentation dating back over 30 years. The suit also alleges Pfizer historically delays publication of scientific papers if such papers contain results unfavorable to the marketing of its products. The Institute for Safe Medication Practices recently reported that it has received notice of nearly 1,000 serious side effects related to Chantix.

Meanwhile, the US Food and Drug Administration (FDA) recently approved the Medication Guide on Chantix and issued an alert to highlight changes to the “Warnings and Precautions” section of the full prescribing information regarding serious neuropsychiatric symptoms linked to Chantix. Symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and both attempted and completed suicide. Many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with a black box warning—the agency’s highest safety alert.

Despite this, health officials in the federal government are urging smokers to use Chantix as part of their efforts to stop smoking despite the drug’s association to suicidal thoughts and behavior. And, while the new smoking cessation guidelines, published by the US Public Health Service, do note the Chantix links with suicide and other psychiatric side effects, the Pfizer drug is promoted as the method most likely to help smokers wanting to quit. The new guidelines are creating controversy, not only because of the strong Chantix recommendation, but also because their lead author, Dr. Michael Fiore, has ties to Pfizer.

As FDA’s review of the problems with Chantix has continued, the FDA states it “appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.” It was because of this that the FDA requested that Pfizer elevate the prominence of this safety information. In the US, 34 Chantix users have reportedly committed suicide. According to an FDA November 20 Early Communication, the agency said its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

Chantix Scandal Prompts Changes at VA

Thu, 10 Jul 2008 00:00:00 -0700

Following revelations that it enrolled combat veterans with Post Traumatic Stress Disorder (PTSD) in a Chantix trial without warning participants of the drugs' suicide risks, the Department of Veterans Affairs is now reviewing drug protocols for such veterans.

In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.

A few weeks ago, ABC News, in conjunction with The Washington Times, aired an investigative report which revealed that veterans enrolled in a Chantix clinical trial - all diagnosed with PTSD - had not been told that the drug was linked to depression, suicide and psychotic behavior. According to the ABC News report, hundreds of Iraq war vets with PTSD were recruited by the VA and paid $30.00 per month to participate in a Chantix behavioral study. Even after the FDA issued its Chantix Early Communication in November, the VA did not notify study participants of its association with suicide. It wasn’t until the FDA issued its second warning, and Pfizer sent out its own alert, that the VA acted. But even then, the VA’s notice didn’t specifically mention suicide.

Following the outcry that resulted from the ABC report, VA Secretary James Peake told a Washington Times reporter that he was personally sending new warning letters to the 940 veterans in the study and some 31,000 other veterans who have been prescribed Chantix by the VA.

A review by the VA Office of Inspector General found that researchers in the study "did not ensure that patients involved in the smoking cessation study were notified of the risk of suicidal thoughts or behavior in a timely manner."

The ABC News report quickly caught the attention of Congress, and yesterday, Peake appeared before the House Committee on Veterans' Affairs to explain the VA's handling of the Chantix trial. Peake has said he "wished" the VA had not taken so long to warn veterans being used in the Chantix test. Peake said his department will now review all drugs prescribed by the VA to veterans with PTSD. Part of that review will be to examine the risks of medications on PTSD vets and to review proper notification procedures.

Committee chair Bob Filner (D-Ca) asked Peake repeatedly why the Chantix study hasn't been ceased. But Peake said that until the VA's internal review on the handling of Chantix is completed, there is no reason to take further action.

FDA Finally Taking Drug Suicide Risks Seriously

Wed, 09 Jul 2008 00:00:00 -0700

On Thursday, federal regulators are expected to recommended tough new safety warnings about suicide risks for 11 epilepsy drugs. Counting the epilepsy drugs, in the past four years, the Food & Drug Administration (FDA) has added or expanded suicide warnings for about 35 medications. In the past, the FDA had been criticized for taking too long to act on - or ignoring altogether - the potential suicide risks of some medications, but now assessing a drug's potential for such side effects seems to have become a greater priority at the agency.

Yesterday, FDA head Andrew Von Eschenbach met with top FDA officials to discuss ways of assessing and dealing with the suicide risks posed by some medications. According to The Wall Street Journal, the officials are contemplating the possibility of working with the National Institutes of Health to more comprehensively deal with the issue. They want to know if new or existing research on molecular activity in the brain could better determine what chemicals are likely to stimulate suicidal ideation. Such information, if it were available, would help drug reviewers better assess suicide risks before drugs are approved.

The FDA almost never considered a medication's suicide risk prior to 2004. But that year, the agency was roundly criticized for taking more than a year to address studies that indicated some antidepressants, such as Paxil, raised the chance of suicidal behavior when taken by children and teens.

Since 2004, suicide warnings - including the agency's strictest notice, the infamous "black box" - have been added to or strengthened more than 50 times, to about 35 drugs. According to The Wall Street Journal, among the 20 best-selling drugs of 2007, six already carry warnings for suicidality. This year, a suicide warning was strengthened for the smoking cessation medication, Chantix, and the FDA is studying reports of suicide associated with Singulair, a popular asthma medication.

The FDA is also now asking some drug makers to conduct studies aimed at detecting suicidal behavior during the approval process. Columbia University Medical Center has developed a framework for detecting such side effects during clinical trials, and it is being used by several companies.

But while consumer advocates praise the FDA's new attention to suicide risks, not everyone is happy - especially the drug makers. They complain that the agency's new focus is adding to their costs. But critics of the industry insist that those costs are small in comparison to the effect the FDA's new efforts could have on patients' lives.

Chantix Worries Prompted Pfizer Lobbyist to Contact VA

Wed, 09 Jul 2008 00:00:00 -0700

A lobbyist for Pfizer - once the head of the Department of Veteran's Affairs (VA) - contacted his old agency about keeping Chantix on its drug formulary, even after the smoking cessation drug was linked to suicides. According to the Washington Times, former VA secretary Anthony J. Principi contacted his old colleagues earlier this year, shortly after the federal government banned pilots and air traffic controllers from using Chantix.

In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.

Chantix again made headlines in May, when the Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the FDA. The study specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of traffic accidents and falls linked to Chantix. As a result of the Institute’s report, the Federal Aviation Administration banned Chantix use by pilots and air traffic controllers.

According to The Washington Times report, Principi contacted officials at the VA after the Institute released its report. Pfizer claims that all Principi did was pass along requests via e-mail asking whether an internal VA study that examined 27 veterans hospitalized for psychotic episodes while taking Chantix would be made public. A company official told the Times that it doesn't consider that to be lobbying - even though Principi was employed as Pfizer's chief lobbyist.

But e-mails reviewed by The Washington Times also reveal that Mr. Principi forwarded inquiries from Pfizer about Chantix's status on the VA's list of prescribed drugs, at one point stating, "I really hate to be a pain, but I keep getting asked these questions."

This isn't the first time that the VA's dealings concerning Chantix have raised concerns. Last month, it was learned that the agency allowed veterans with Post Traumatic Stress Disorder (PTSD) to be enrolled in a Chantix trial, but waited months after the FDA issued its last suicide warning to notify the trial participants - along with thousands of other veterans prescribed Chantix through the VA - about those dangers.

In fact, it wasn't until a joint ABC News/Washington Times investigation questioned the Chantix clinical trial that the VA sent out a Chantix warning that specifically mentioned suicide.

VA Warned of Chantix Danger in 2007

Tue, 08 Jul 2008 00:00:00 -0700

The Department of Veterans Affairs (VA) was warned by its own doctors in 2007 that some veterans using the smoking cessation drug Chantix had experienced psychotic episodes and other bizarre behavior. Yet it wasn't until last month that the VA informed veterans using Chantix that the drug was linked to suicide and other psychiatric side effects.

A few weeks ago, ABC News aired an investigative report which revealed that veterans enrolled in a Chantix clinical trial - all diagnosed with post traumatic stress disorder (PTSD) - had not been told that the drug was linked to depression, suicide and psychotic behavior. According to the ABC News report, hundreds of Iraq war vets with PTSD were recruited by the VA and paid $30.00 per month to participate in a Chantix behavioral study. Even after the FDA issued its Chantix Early Communication in November, the VA did not notify study participants of its association with suicide. It wasn’t until the FDA issued its second warning, and Pfizer sent out its own alert, that the VA acted. But even then, the VA’s notice didn’t specifically mention suicide.

Following the outcry that resulted from the ABC report, VA Secretary James Peake told a Washington Times reporter that he was personally sending new warning letters to the 940 veterans in the study and some 31,000 other veterans who have been prescribed Chantix by the VA. Peake also said he has asked VA doctors to review “the communications process” involving all VA studies using veterans who are suffering from PTSD. Some 400,000 veterans are being treated for PTSD by the VA.

But it now appears that doctors at the VA were concerned about Chantix side effect reports months before the FDA issued its November Chantix Early Communication. According to the Washington Times, doctors at the VA were getting reports of disturbing behavior among some Chantix users in early 2007. By November, the VA had data that indicate that nearly one out of every 1,000 veterans taking Chantix had been hospitalized for severe psychosis, a rate noticeably higher than for veterans trying to stop smoking with alternative treatments like nicotine replacement, the documents show.

Even with those disturbing numbers, the VA was prescribing Chantix to more and more veterans - and it was continuing to enroll vets with PTSD in the Chantix behavioral study. The VA has since acknowledge that the rate serious side effects among PTSD patients in that trial was about one out of every two veterans.

Faced with mounting reports of psychiatric side effects, the VA began an investigation in November 2007, which took the agency 4 months to complete. That review found that among 27 patients taking Chantix who were admitted to VA hospitals for psychiatric problems since the drug was approved for the market in 2006, 11 had attempted suicide, one attempted homicide, nine had suicidal thoughts, and six were suffering from hallucinations. The rate of such hospitalizations for Chantix users - about 9.8 for every 10,000 patients - was much higher than it was among veterans using other smoking cessation methods. By the time the VA report was completed in March 2008, the FDA had already issued several Chantix warnings, and the drug's labeling was updated to make warnings on suicide and other psychiatric side effects more prominent.

But the VA did not make its Chantix study public, and officials who conducted it never recommended that veterans taking the drug be issued a warning. It wasn't until May that the agency sent out a letter telling veterans that they should be careful operating heavy machinery if they are taking Chantix. Finally, on June 18 - after ABC News aired its report - the VA finally sent out letters to all veterans taking the drug to specifically warn them that suicidal tendencies were a possible side effect.

Tomorrow, a Congressional committee will be looking at the VA's handling of the Chantix debacle. Those scheduled to testify at the hearing include VA Secretary James B. Peake and Dr. John D. Daigh, assistant inspector general. Lawmakers will be wanting an explanation for the VA's long delay in warning veterans about the dangers associated with Chantix.

Drug Makers Decry FDA Safety Push

Tue, 01 Jul 2008 00:00:00 -0700

Drug makers are complaining that the Food & Drug Administration (FDA) is too focused on, of all things, safety. The pharmaceutical industry says the FDA' s tougher stance is slowing the arrival of new drugs to the market, but consumer advocates - citing recent scandals involving defective drugs - say a stronger focus on safety is long overdue.

According to the Wall Street Journal, the FDA approved just 19 new medicines last year, the fewest in 24 years, and announced about 75 new or revised "black-box" warnings about potential side effects -- the agency's strongest -- twice the number in 2004. The number of so-called approvable letters, which typically postpone FDA approval decisions pending more data, increased by 40% last year.

Drug makers are less-than-enthusiastic about the FDA's new approach. Schering-Plough Corp. Chief Executive Fred Hassan told The Wall Street Journal that the new safety focus means that drug companies must now spend significantly more time and money to get a drug approved - and even then, approval is not guaranteed. "What will it take to get new drugs approved?" Hassan said. "The point is, we don't know."

The FDA's new caution can be traced to the Vioxx debacle. Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The FDA ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.

Shortly after Vioxx was pulled from the market, it was revealed the FDA had tried to silence the drug expert who headed that analysis. Dr. David Graham, associate director for science in the FDA Drug Center’s Office of Drug Safety, told Senate investigators that he had been subjected to veiled threats and intimidation when he informed the FDA of his findings.

Following the Vioxx mess, several other drug safety scandals intensified pressure on the agency. For instance, after a study was published last May detailing heart risks with the diabetes drug Avandia, it was revealed that in 2005 GlaxoSmithKline had informed the FDA of a study it had conducted that produced similar results. However, both the agency and the manufacturer felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues.

And just this year, it was learned that the makers of Vytorin withheld a study that found the expensive cholesterol medication was no more effective than cheaper statins for two years. Poor FDA oversight of foreign drug plants allowed tainted heparin to kill at least 149 people this year, and the agency has been slow to take strong action against the stop-smoking drug Chantix, which has been linked to suicides.

These and other scandals have strained the credibility of both the FDA and the pharmaceutical industry. The FDA has apparently heard the criticism. In addition to being tougher on new drug approvals, the agency is adding warnings about cancer risk to arthritis drugs for children, and warnings about suicide risk to epilepsy drugs. The FDA is also considering instituting tougher approval criteria for diabetes drugs.

None of this sets well with the pharmaceutical industry, which relies on new drug approvals to stay in the black. But considering the industry's recent history of manipulating clinical data, concealing dangerous side effects and aggressively promoting risky products, drug makers have only themselves to blame.

Another Chantix Warning in Canada

Tue, 24 Jun 2008 00:00:00 -0700

For the second time since April, health officials in Canada have issued a warning about Chantix, Pfizer's anti-smoking medication. This time, Health Canada is warning that Chantix - sold in Canada as Champix - has caused unusual feelings of agitation, depressed mood, hostility, changes in behavior or impulsive or disturbing thoughts, such as ideas of self-harm or of harming others, in some users.

In April, Health Canada issued an alert warning that Chantix has been linked to 107 adverse reactions in Canada. According to the ageny nearly half of those reports involved psychiatric behavior. In its latest alert, Health Canada has said that in the year following its approval, 226 Canadian cases of neuropsychiatric adverse events have been reported in patients taking the drug.

Health Canada also issued the following guidelines:

People taking Chantix should tell their doctor if they experienced depression or other mental health problems before taking Chantix, as these symptoms may worsen while taking the drug.
Patients should stop taking Chantix and tell their doctor right away if they, their family or caregiver notice any of these symptoms, if they experience these symptoms in a way that is not typical for them or if they have thoughts of self-harm or of harming others.
Chantix has not been studied in people with mental health problems, and therefore a doctor should monitor such patients closely for new or worsened emotional or behavioral problems while on the medication.

In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.

Veterans to Get Chantix Suicide Warning

Fri, 20 Jun 2008 00:00:00 -0700

About 32,000 veterans taking Chantix will soon receive a warning that the stop-smoking drug is linked to suicidal behavior. The decision by the Veterans Administration (VA) comes after ABC News aired an investigative report which revealed that veterans enrolled in a Chantix trial - all diagnosed with post traumatic stress disorder (PTSD) - were not told for several months that the drug was associated with suicide.

In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.

According to the ABC News report, hundreds of Iraq war vets with PTSD were recruited by the VA and paid $30.00 per month to participate in a Chantix behavioral study. Even after the FDA issued its Chantix Early Communication in November, the VA did not notify study participants of its association with suicide. It wasn't until the FDA issued its second warning, and Pfizer sent out its own alert, that the VA acted. But even then, the VA's notice didn't specifically mention suicide.

Following airing of the ABC News Report, VA Secretary James Peake told a Washington Times reporter that he was personally sending new warning letters to the 940 veterans in the study and some 31,000 other veterans who have been prescribed Chantix by the VA. Peake also said he has asked VA doctors to review "the communications process" involving all VA studies using veterans who are suffering from PTSD. Some 400,000 veterans are being treated for PTSD.

Still, the VA will allow the Chantix study using PTSD veterans to continue, however no more participants will be enrolled. Peake said he would not have any problems halting the Chantix study if needed, but insisted that there is no evidence that such a more is necessary.

Chantix Tested on Vets with PTSD

Tue, 17 Jun 2008 00:00:00 -0700

A shocking new report alleges that war veterans used as test subjects for Chantix were not told upfront that the anti-smoking drug was linked to suicidal behavior and other psychiatric side effects. What's worse, some of the Iraq war veterans used as Chantix guinea pigs were suffering from post-traumatic stress disorder (PTSD), a condition that already placed them at a higher risk of suicidal behavior.

In the US, 34 Chantix users have reportedly committed suicide. In November 2007, the Food & Drug Administration (FDA) issued an "Early Communication" that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.

Last month, the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event repots to the FDA. The report specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of a dozen traffic accidents linked to Chantix. The report caused the Federal Aviation Administration to ban the use of Chantix by pilots and air traffic controllers.

Now, a joint investigation conducted by ABC News and the "Washington Times" is raising questions about the ethics of some Chantix clinical trials. James Elliott, a 30-year-old ex-Army sniper diagnosed with PTSD told ABC News that he agreed to participate in a Chantix trial for $30.00 per month. Months after he began taking the drug, Elliott suffered a mental breakdown, experiencing a relapse of Iraq combat nightmares he blames on Chantix.

One night this past February, he "snapped" and left home with a loaded gun. His fiancée called police, concerned because he was acting as though he was still in combat. Police had no choice but to subdue Elliott with a taser and arrest him.

Three weeks later, the Veterans Administration finally advised the participants in the Chantix study that the drug may cause serious side effects, including "anxiety, nervousness, tension, depression, thoughts of suicide, and attempted and completed suicide." By the time that notice went out on February 29, 2008, the FDA had already issued three separate Chantix suicide warnings. But officials at the Veterans Administration told ABC News that those warnings "didn't justify an emergency warning at that level."

The same official also told ABC News that the Veterans Administration sees no reason to discontinue the Chantix study. As it stand right now, about 140 veterans diagnosed with PTSD continue to receive Chantix as part of a smoking cessation study.

Chantix Concerns Ignored by FDA, Doctor Says

Mon, 16 Jun 2008 00:00:00 -0700

Concerns over Chantix side effects were reportedly ignored by the Food & Drug Administration (FDA) last year when they were raised by a doctor who is a top expert in smoking cessation. John Spangler, director of Tobacco Intervention Programs at the Wake Forest University School of Medicine in Winston-Salem, N.C., says that a study that was used to demonstrate that Chantix was safe for long-term use was not thorough enough to assure the drug's safety.

Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. Since its approval, over 6 million Chantix prescriptions have been written.

In the US, 34 Chantix users have reportedly committed suicide. In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency's highest safety alert.

Last month, the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event repots to the FDA. The report specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of a dozen traffic accidents linked to Chantix. The report caused the Federal Aviation Administration to ban the use of Chantix by pilots and air traffic controllers.

Dr. Spangler is one person who is not surprised that questions have arisen about the safety of Chantix. According to report on ABC News, last year, he raised concerns about heart and vision effects in people who took the drug for at least one year. Spangler told ABC that a safety study by researchers employed by Pfizer and published in a relatively obscure medical journal looked at far too few subjects — a total of only 251 taking the drug — to determine whether or not the drug is safe when used over that duration. Yet, the researchers concluded that Chantix could be safely administered for up to one year.

Dr. Spangler also did his own analysis of the Chantix study, and told ABC News that the authors failed to mention that study subjects who took the drug were 2.5 times as likely to experience a serious adverse event. Dr. Spangler said the small size of the study made it impossible to determine if the adverse events were the results of chance, or were caused by Chantix.

It is Dr. Spangler's contention that a bigger study must be conducted to determine the safety of Chantix. Until it is done, doctors who prescribed the drug must consider the possibility that an increased risk exists. To date, the FDA has not asked Pfizer to conduct such a long-term study.

Pfizer Still Pushing Chantix, Even for Mentally Ill

Fri, 06 Jun 2008 00:00:00 -0700

Pfizer Inc., trying desperately to save the reputation of Chantix, is claiming the anti-smoking drug is safe - even for people suffering from mental illness. This, in spite of the fact that the Food & Drug Administration (FDA) is reviewing Chantix due to a number of serious side effects, including severe depression and suicide.

Chantix was supposed to be a blockbuster for Pfizer. It was approved in 2006, and was the first nicotine receptor partial agonist - meaning it blocks nicotine receptors in the brain - on the market. But there have been at least 34 reports of suicides related to Chantix in the US. According to an FDA Nov. 2007 Early Communication, the agency said that its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling.

Then last month, the Institute for Safe Medication Practices issued a report detailing Chantix adverse event repots to the FDA. The report specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of traffic accidents and falls linked to Chantix. As a result of the Institute’s report, the Federal Aviation Administration banned Chantix use by pilots and air traffic controllers. Earlier this week, the Federal Motor Carrier Safety Administration said that “… it appears that medical examiners should not certify a driver taking Chantix because the medication may adversely affect the driver’s ability to safely operate a commercial motor vehicle.” The report also led the FDA to announce another Chantix safety review.

Pfizer, which is counting on Chantix to be one it biggest growth drivers, has embarked on an aggressive campaign to prop up the drug's image. The campaign includes advertisements in the country's biggest newspapers, as well as a letter campaign to physicians. Pfizer will also submit “opinion” pieces to the editorial pages of newspapers meant to address “misconceptions” about the drug.

Yesterday, as part of that campaign, Pfizer held a roundtable discussion with members of the media. Representatives from Pfizer insisted Chantix is safe, and cited studies - which were paid for by the company - that found no suicide risk. One of the key points the company tried to make at the meeting was that depression - which is a risk factor for suicidal behavior - is not unusual in people who are trying to quit smoking. But some of the reports involving bizarre behavior in Chantix users - including that of musician killed when he tried to break down a neighbors door - sound a bit extreme to be typical of nicotine withdrawal.

Meanwhile, in an Associated Press interview, Pfizer Senior Medical Director Dr. Martina Flammer said Chantix is even safe for the mentally ill, although he suggested such patients inform doctors of their medical history. Pfizer also said it has funded grants to independent scientists to investigate severe adverse events of Chantix in patients with depression, schizophrenia and alcoholics.

But David Gonzales, co-director of Oregon Health & Science University's Smoking Cessation Center and who led Chantix clinical trials, told the Associated Press that people with schizophrenia and other mental illness were deliberately excluded from those studies so that adverse events couldn't be attributed to a pre-existing condition.

Florida Woman Blames Chantix for Husband's Strange Trip

Tue, 03 Jun 2008 00:00:00 -0700

Recently, a man and his daughter went missing for nearly two days. The wife and mother says that smoking cessation drug Chantix is to blame. Susan Marino says her husband, Michael, was taking Chantix to help him quit smoking. Michael—who was with their eight-year-old daughter, Lena—dropped Susan off at a doctor’s office last Thursday morning and never returned.

Police ultimately found Michael and Lena on Saturday morning off of Interstate-4 near Orlando, Florida. According to authorities, Michael appeared disoriented. Susan reported that the auto’s computer indicated that Michael had driven for 44 hours and 1,800 miles; he spent over $500 on gas. Lena was fine.

Although doctors are unclear about what occurred, Susan believes Michael’s disorientation is related to Chantix. Susan says Michael took Chantix for the past two weeks and that, a few days after he started Chantix, some of his co-workers reportedly said he started acting strange and didn't seem like himself. The Chantix warning label states the drug might cause neuropsychiatric symptoms, including changes in behavior, agitation, depression, and suicidal behavior.

Michael was admitted to Physicians Regional Medical Center and after a variety of tests his wife reports no signs of an underlying medical problem such as a stroke, which is why she believes it is related to Chantix.

Meanwhile, the US Food and Drug Administration (FDA) recently approved the Medication Guide on Chantix and issued an alert to highlight changes to the “Warnings and Precautions” section of the full prescribing information regarding serious neuropsychiatric symptoms linked to Chantix. Symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and both attempted and completed suicide. Many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with a black box warning—the agency’s highest safety alert.

Despite this, health officials in the federal government are urging smokers to use Chantix as part of their efforts to stop smoking despite the drug’s association to suicidal thoughts and behavior. And, while the new smoking cessation guidelines, published by the US Public Health Service, do note the Chantix links with suicide and other psychiatric side effects, the Pfizer drug is promoted as the method most likely to help smokers wanting to quit. The new guidelines are creating controversy, not only because of the strong Chantix recommendation, but also because their lead author, Dr. Michael Fiore, has ties to Pfizer.

As FDA’s review of the problems with Chantix has continued, the FDA states it “appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.” It was because of this that the FDA requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information.

In the US, 34 Chantix users have reportedly committed suicide. According to an FDA November 20 Early Communication, the agency said its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

FDA Taking Another Look at Chantix

Fri, 30 May 2008 00:00:00 -0700

The release of a Chantix study last week that linked the drug to numerous side effects has prompted the Food & Drug Administration (FDA) to initiate another safety review of the drug. The review will mark the second such investigation for Chantix, which is already being scrutinized because of its association with psychiatric side effects, including suicide and depression.

Chantix is a popular anti-smoking drug made by Pfizer, Inc. It was approved in 2006, and was the first nicotine receptor partial agonist - meaning it blocks nicotine receptors in the brain - on the market. Last Tuesday, the Institute for Safe Medication Practices issued a report detailing Chantix adverse event repots to the FDA. The report specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of traffic accidents and falls linked to Chantix. As a result of the Institute’s report, the Federal Aviation Administration banned Chantix use by pilots and air traffic controllers. Earlier this week, the Federal Motor Carrier Safety Administration said that "… it appears that medical examiners should not certify a driver taking Chantix because the medication may adversely affect the driver’s ability to safely operate a commercial motor vehicle.”

According to Reuters, Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said the agency is reviewing all the reported cases. "We're are looking at them, but it takes awhile," she said in an interview. Woodcock said the agency does not yet know whether the drug directly caused the complications cited in the researchers' report.

No one should expect the FDA to reach a conclusion on Chantix anytime soon, however. Woodcock conceded that the agency simply does not have the resources available to complete the Chantix probe promptly.

This will be the second time the FDA has taken a look at Chantix. After the drug was linked to 34 suicides in the US, the agency began a safety review. According to an FDA Nov. 2007 Early Communication, the agency said that its preliminary assessment revealed that many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling.

Chantix Marketing Blitz Launched

Thu, 29 May 2008 00:00:00 -0700

Pfizer Inc. has started a huge marketing blitz to save the reputation of its once-promising anti-smoking drug Chantix. Chantix has been recently linked to a variety of ills, including suicidal thoughts and behavior, heart problems, seizures and traffic accidents. But Pfizer has a lot riding on Chantix - the drug is its second biggest growth driver - so the drug maker is making a desperate effort to downplay Chantix side effects.

Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the Food & Drug Administration (FDA). It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. Some analysts had estimated that Chantix sales could reach $2.28 billion by 2012.

But the drug has been the subject of disturbing side effect reports. In the US, 34 Chantix users have reportedly committed suicide. According to an FDA Nov. 20 Early Communication, the agency said that its preliminary assessment revealed that many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling.

Last Tuesday, the Institute for Safe Medication Practices issued a report detailing Chantix adverse event repots to the FDA. The report specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of traffic accidents and falls linked to Chantix. As a result of the Institute’s report, the Federal Aviation Administration banned Chantix use by pilots and air traffic controllers. Earlier this week, the Federal Motor Carrie Safety Administration said that "… it appears that medical examiners should not certify a driver taking Chantix because the medication may adversely affect the driver’s ability to safely operate a commercial motor vehicle.”

To quell Chantix safety concerns, Pfizer is preparing to run ads in the country's five largest newspapers today, including the New York Times and Wall Street Journal, a company spokesperson told Bloomberg.com. According to Bloomberg.com, the new ads will feature a letter from Pfizer Chief Medical Officer Joe Feczko telling readers about the dangers of smoking and the benefits of Chantix. It says 44 percent of patients who took Chantix in its clinical trials quit smoking after 12 weeks. The ads also tell patients to stop taking the drug if their mood or behavior changes.

Pfizer is also in the process of sending letters to 300,000 health-care professionals and plans to hold briefings with reporters. In addition, the company will start running television commercials in early June that talk about the importance of quitting smoking without naming Chantix. Pfizer will also submit "opinion" pieces to newspapers meant to address "misconceptions" about the drug.

It is little wonder that Pfizer is in such a panic over Chantix. Bloomberg.com reports that the drug has been touted as a way to help offset $12 billion in sales that the company's Lipitor cholesterol medicine will begin losing to generic competition in 2010.

How much this campaign will help bolster Chantix remains to be seen. The controversial drug is under fire on several fronts. Norman Edleman, chief medical officer for the American Lung Association in New York, told Bloomberg.com last week that doctors are now using the pill only when other treatments fail. The FDA said last week it will be reviewing all Chantix side effect reports, but is focusing on psychiatric side effects first. Congress is also taking a look at Chantix, and the FDA is scheduled to brief the staff of Republican Senator Charles Grassley about Chantix on June 3. Grassley recently sent the agency a letter questioning the FDA's response to Chantix side effects reports.

Chantix Too Dangerous for Truckers and Bus Drivers, Federal Agency Says

Wed, 28 May 2008 00:00:00 -0700

A federal agency has said truckers and bus drivers should steer clear of the smoking cessation drug Chantix. The move comes after a recent study indicated that Chantix put users at a higher risk for traffic accidents. It is just the latest problem linked to the Pfizer drug, which has also been linked to psychological side effects, including suicidal thoughts and behavior.

Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the Food & Drug Administration (FDA). It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.

But last week, the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event repots to the FDA. The report specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of a dozen traffic accidents linked to Chantix. The Institute’s report has already gotten the attention of the Federal Aviation Administration, which has banned its use by pilots and air traffic controllers.

Now, the Federal Motor Carrier Safety Administration (FMCSA), a division of the Department of Transportation, is warning bus and truck drivers to stay off Chantix. In a statement, the FDCSA told CBS 11 in Texas that "... it appears that medical examiners should not certify a driver taking Chantix because the medication may adversely affect the driver's ability to safely operate a commercial motor vehicle."

Since its approval, Chantix has been the subject of a number of safety concerns. Chief among them is its apparent link to suicidal thoughts and behavior. Last year, in a Nov. 20 Early Communication, the FDA said that a preliminary assessment of Chantix suicide reports revealed that many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling.

None of this is good news for Pfizer. Chantix was Pfizer’s most promising drug, with some analysts estimating its sales could reach $2.28 billion by 2012. But Chantix’s problems could soon have many rethinking those forecasts. Some analysts have already said forecasts for Chantix sales could be downgraded by as much as 30 percent.

Chantix Side Effects Bad News for Pfizer

Tue, 27 May 2008 00:00:00 -0700

Chantix, once hailed as a huge success for drug maker Pfizer Inc., is quickly losing its luster. Already linked to suicidal thoughts and behavior, a new report last week said Chantix could be associated with heart problems and other serious side effects. Chantix was Pfizer's most promising drug, with some analysts estimating its sales could reach $2.28 billion by 2012. But Chantix's problems could soon have many rethinking those forecasts.

Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the Food & Drug Administration (FDA). It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.

In the US, 34 Chantix users have reportedly committed suicide. According to an FDA Nov. 20 Early Communication, the agency said that its preliminary assessment revealed that many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling.

Last Tuesday, the Institute for Safe Medication Practices issued a report detailing Chantix adverse event repots to the FDA. The report specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of traffic accidents and falls linked to Chantix. The Institute's report has already gotten the attention of the Federal Aviation Administration, which has banned its use by pilots and air traffic controllers.

None of this is good news for Pfizer. It is expected that many analysts will revise their once-rosy Chantix sales forecasts soon. Some analysts have already said forecasts for Chantix sales could be downgraded by as much as 30 percent. Unfortunately for Pfizer, Chantix is the company's second biggest growth driver, after Lyrica, a drug for fibromyalgia.

Smoking Cessation Drug, Chantix, May Cause Serious Heart Side Effects

Thu, 22 May 2008 00:00:00 -0700

Tuesday, the Institute for Safe Medication Practices, a drug watchdog group, highlighted some serious physical side effects, which may be linked to Chantix, Pfizer's popular smoking-cessation drug. Chantix has been in the news lately over links to adverse psychiatric issues, drawing more attention to the already beleaguered Food and Drug Administration (FDA) and its questionable drug-safety monitoring practices.

The Institute examined serious adverse side effect reports provided to FDA, including reports of nearly 1,000—988, to be exact—serious injuries linked to Chantix in the U.S. during last year's fourth quarter, a figure higher than any other medication during that same time frame. The report specifically cites 173 serious events described as accidental injuries, including 28 road accidents and 77 falls as well as 68 cases of blurred vision, 86 cases involving seizures, and 372 reports of movement disorders. The researchers recommended the FDA initiate an epidemiological study to assess potential risks. Chantix was approved in May 2006.

“We have immediate safety concerns about the use of varenicline (Chantix) among persons operating aircraft, trains, buses, and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury," the researchers said in the report. Chantix has linked to issues connected to psychiatric reactions that include including suicide; however, this new information discusses links to serious adverse physical reactions such as cardiac episodes, seizures, diabetes, dizziness, loss of consciousness, and abnormal spasms and movements.

On Wednesday, the Federal Aviation Administration (FAA) banned Chantix use by pilots and air traffic controllers when the Institute called the FAA’s attention to its report. FAA spokesman Les Dorr said the Chantix ban is effective immediately and that it was notifying unions representing pilots and controllers. He said the FAA is unaware of any aviation accident caused or contributed to by Chantix.

An FDA spokeswoman acknowledged that the Institute’s study presents safety signals; however, due to FDA staffing shortages, the agency is focusing—for now—on reviewing Chantix's potential psychiatric effects. Pfizer said the report's findings are consistent with the drug's label, which lists many of the events cited in the Institute's report as "infrequent" or "rare.”

The FDA has been hotly criticized in recent months for not having strong post-approval tracking of prescription drugs and has been at the core of a number of drug safety issues. Last year, Congress gave the FDA the authority to order drug label changes and conduct more safety studies after several medicines, including Merck & Co.’s Vioxx, were pulled off the market due to safety risks.

Meanwhile, the report issued by the Institute and the FAA ban on Chantix use comes months after the FDA revealed that the connection between Chantix and serious psychiatric problems is "increasingly likely." In the US, 34 Chantix users have reportedly committed suicide. According to an FDA November 20 Early Communication, its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

New FDA Alerts on Chantix

Sun, 18 May 2008 00:00:00 -0700

The US Food and Drug Administration has just approved the Medication Guide on the smoking cessation drug, Chantix, and has issued an alert to highlight changes to the “Warnings and Precautions” section of the full prescribing information regarding serious neuropsychiatric symptoms linked to Chantix. Symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and both attempted and completed suicide. Many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with a black box warning—the agency’s highest safety alert.

Despite this, health officials in the federal government are urging smokers to use Chantix as part of their efforts to stop smoking despite the drug’s association to suicidal thoughts and behavior. And, while the new smoking cessation guidelines, published by the US Public Health Service, do note the Chantix links with suicide and other psychiatric side effects, the Pfizer drug is promoted as the method most likely to help smokers wanting to quit. The new guidelines are creating controversy, not only because of the strong Chantix recommendation, but also because their lead author, Dr. Michael Fiore, has ties to Pfizer.

While some have experienced neuropsychiatric symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet stopped smoking. Generally, neuropsychiatric symptoms developed during Chantix treatment; however, in others, symptoms began after stopping Chantix therapy. Chantix, approved in the US in 2006, blocks nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the FDA and was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.

The FDA warns that if you or your family or caregiver notice agitation, depressed mood, or changes in behavior not typical for you, or if you have suicidal thoughts or actions, stop taking Chantix immediately and call your doctor. The FDA first informed the public about the possibility of serious neuropsychiatric symptoms last November when information about such symptoms was added to the “Post-Marketing Experience” section of the prescribing information.

As FDA’s review of the problems with Chantix has continued, the FDA states it “appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.” It was because of this that the FDA requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information.

In the US, 34 Chantix users have reportedly committed suicide. According to an FDA November 20 Early Communication, the agency said that its preliminary assessment revealed that many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases was not clear, the FDA said, because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness; however, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking.

Many Popular Drugs Linked to Suicide

Thu, 08 May 2008 00:00:00 -0700

Suicide is common in the US, representing the fourth leading cause of death for those aged 18 to 65 and the third leading cause for those aged 15 to 24. Add to those figures the complexity of medications. In recent years, disturbing reports have suggested that side effects of some popular drugs - such as Chantix, Accutane, Singular and Paxil - include suicidal thoughts and behavior.

Reports have been filed with drug makers and the Food and Drug Administration (FDA) on at least six drugs or drug classes that may be linked to suicide or suicidal thoughts. Recently, the FDA released notices about several such medications including Singlulair; Epilepsy drugs including carbamazepine, gabapentin, felbamate, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, and valproate; and the smoking-cessation drug Chantix. Reports have been filed on SSRI antidepressants including Paxil and Prozac, the influenza drug Tamiflu, and the acne medicine Accutane. "The brain is a complex organ, and most of the drugs are complex as well,’’ says Dr. Thomas Laughren, head of the division of psychiatric products at the FDA. "It’s not unreasonable to think that a drug that gets into the brain may have effects other than you hope they would.’’

Kelly Posner, principal investigator at the Center for Suicide Risk Assessment at Columbia University in New York, is working with the FDA to determine suicide risks and at-risk categories; Posner’s quantitative tools and questionnaires are being applied to drugs on the market and in testing. "We know that whether or not these drugs actually cause suicidal thought or action is a question we have to answer, but up until now, none of the clinical trials for the drugs were set up to address the question,’’ says Posner.

There are theories, says Jason Noel, director of clinical pharmacy services at Rosewood Center in Owings Mills, Maryland. Asthma medication Singulair has a similar chemical pathway to steroids, which can affect behavior and mood and an asthma diagnosis can trigger suicide or depression because it adversely affects daily living. Fatigue is a symptom of depression, the initial benefit of antidepressants is increased energy, and improving depression can take weeks; therefore, some may use extra energy to act on suicidal thoughts. Suicidal thoughts in patients taking epilepsy drugs have been reported in patients on such medications for epilepsy, depression, or other psychiatric conditions; however, not generally in those on the drugs for migraines. Chantix blocks pleasure pathways that make nicotine so satisfying, which suppresses other pleasure and happiness, leading to depression. But, stopping smoking can be a risk factor for depression and smoking is a risk factor for suicide.

Finding links has risks. When the FDA discovered an increase in suicidal thinking in children and young adults taking antidepressants, warnings were added to Paxil and Prozac labeling. "Use of antidepressants went down and the suicide rate went up,’’ says Dr. Paula Clayton, medical director of the American Foundation for Suicide Prevention in New York.

Meanwhile, Congressman Bart Stupak (Democrat-Michigan) reported his teenage son B.J. killed himself in 1999 after several months on Accutane and said in 1998, the FDA publicly noted reports of depression, psychosis, and suicidal thoughts and actions with Accutane; in 1999 when B.J. was prescribed Accutane, their doctor did not inform them of the risk and the prescription’s patient information did not include it.

Chantix Promoted By US Government in Guidelines Written by Former Pfizer Consultant

Thu, 08 May 2008 00:00:00 -0700

Health officials in the federal government are urging smokers to use Chantix as part of their efforts to stop smoking - despite the drug's association to suicidal thoughts and behavior. New smoking cessation guidelines, published by the US Public Health Service, do note that Chantix has been linked with suicide and other psychiatric side effects. But they promote the Pfizer drug as the method most likely to help smokers wanting to quit. The new guidelines are creating controversy, not only because of the strong Chantix recommendation, but also due to the fact that their lead author, Dr. Michael Fiore, has ties to Pfizer.

Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.

In the US, 34 Chantix users have reportedly committed suicide. According to an FDA Nov. 20 Early Communication, the agency said that its preliminary assessment revealed that many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases was not clear, the FDA said, because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, the FDA said it was working with Pfizer to finalize a Medication Guide for patients. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency's highest safety alert.

Considering the recent FDA notices, it is not surprising that the US Public Health Service's Chantix recommendation is raising eyebrows. Critics say Chantix has not been on the market long enough to known the true extent of its suicide risks, or what other side effects it might carry.

Other critics have said that Dr. Fiore's involvement makes the guidelines little more than a Chantix sales pitch. Fiore was once a paid consultant to Pfizer. Though he says he cut ties with Pfizer in 2005, critics say those ties could still cause him to be biased in favor of Chantix.

According to the Associated Press, the new guidelines encourage doctors to speak with their smoking patients about Chantix, and claim it works better than other methods or drugs. The guidelines say doctors should consider asking about their patients' psychiatric history before prescribing Chantix. Doctors also should monitor patients for changes in mood and behavior while on the drug.

But some smoking experts question claims that Chantix is more effective than other smoking cessation methods. Lois Biener, a researcher of tobacco use and smoking cessation efforts at the University of Massachusetts in Boston, told the Associated Press that most people who quit do so without smoking essation drugs. While a few studies have shown some benefit, it's "way less than what is claimed" by medication advocates, Biener said.

Suicidal Behavior Linked to Chantix Reported in Canada

Fri, 11 Apr 2008 00:00:00 -0700

Chantix, the anti-smoking drug marketed by Pfizer, Inc., has been linked to 107 adverse reactions in Canada. According to the country's regulatory agency, Health Canada, nearly half of those reports involved psychiatric behavior. In fact, at least seven people in that country - where Chantix is sold as Champix - became suicidal while taking the drug. Though Pfizer recently modified the Chantix label to make information on psychiatric side effects more prominent, Health Canada said it saw no reason at this time to issue a Champix public health advisory. Such an advisory was issued by the US Food & Drug Administration (FDA) in February.

Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.

In the US, 34 Chantix users have reportedly committed suicide. According to an FDA Nov. 20 Early Communication, Pfizer had submitted several postmarketing cases to the agency describing suicidal thoughts and occasional suicidal behavior possibly linked to Chantix use. At the time, the FDA said that its preliminary assessment revealed that many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases was not clear, the FDA said, because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, the FDA said it was working with Pfizer to finalize a Medication Guide for patients.

In Canada, 46 Champix side effect reports involved psychiatric reactions including aggression, depression and suicidal thinking. Others involved amnesia, abnormal dreams, anxiety, insomnia, and abnormal thinking. Seven people experienced "suicidal tendency" while on Champix. Four had no personal history of a psychiatric illness, including a 33-year-old woman who became suicidal 11 days after starting the drug, according to the most recent issue of Health Canada's Canadian Adverse Reaction Newsletter. One woman had a history of mental illness. In the remaining two cases, their psychiatric histories were not known. No Champix users in Canada have actually committed suicide, the agency said.

Despite such reports, Health Canada is not planning any public communication on Champix psychiatric side effects at this time. The reports are based on suspicion only, the agency said, and not considered scientific proof of a drug's effect. But it's believed only about one percent of adverse drug reactions are reported under Canada's voluntary reporting system. Health Canada said it's reviewing Champix and will "take appropriate action as considered necessary."

Chantix Suicide Risk Warrants Black Box Warning, Consumer Group Says

Thu, 03 Apr 2008 00:00:00 -0700

Chantix, the smoking cessation drug linked to suicidal behavior and other psychiatric problems, should bear the Food & Drug Administration's (FDA) strongest safety warning, the consumer group Public Citizen says. Earlier this year, warnings of suicide and other behavioral problems seen in some Chantix users were given more prominent placement on the drug's label, but Public Citizen says those warnings are still not strong enough, and wants the FDA to require they be highlighted by a "black box".

Chantix, made by Pfizer Inc., was approved in 2006. Chantix works by blocking nicotine receptors to the brain, and was the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. But soon after it was approved, some Chantix users began exhibiting signs of depression, suicidal thoughts and behavior, and other psychiatric problems.

According to an FDA Nov. 20 Early Communication, Pfizer had submitted several postmarketing cases to the agency describing suicidal thoughts and occasional suicidal behavior possibly linked to Chantix use. At the time, the FDA said that its preliminary assessment revealed that many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases was not clear, the FDA said, because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of this safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, the FDA is working with Pfizer to finalize a Medication Guide for patients.

Public Citizen, which includes Chantix on its "Worst Pills" listing, wants the FDA to do more. The group is requesting that the FDA require Pfizer to add a "black box" warning about suicide and other psychiatric side effects associated with Chantix on the drug's label. A black box warning is the FDA's most serious type of safety warning. In most cases, when Public Citizen petitions the FDA for a black box warning on a drug, the FDA eventually agrees.

The Public Citizen request is in response to a growing number of adverse reaction reports related to Chantix. According to an analysis of Chantix adverse reactions spanning the first 9 months of 200 conducted by CBS11, the number of adverse events for Chantix rose from nearly 700 in the first 3 months, to a total of 3,700 at the end of the nine-month period. Dr. Sidney Wolfe of Public Citizen also told CBS11 that the FDA data shows an increase in adverse events in early 2007, before the well-publicized death of Dallas musician carter Albrecht, who died in September after taking Chantix. It's believed the pills made him exhibit bizarre behavior resulting in his death.

Chantix Gets FDA Suicide Warning

Fri, 01 Feb 2008 00:00:00 -0800

Chantix, the anti-smoking drug made by Pfizer, was the subject of Food & Drug Administration (FDA) suicide warning today. Today’s FDA warning follows a Nov. 20, 2007, FDA Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.

Chantix, approved in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy

According to the FDA Nov. 20 Early Communication, Pfizer had submitted several postmarketing cases to the agency describing suicidal thoughts and occasional suicidal behavior possibly linked to Chantix use. At the time, the FDA said that its preliminary assessment revealed that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear, the FDA said, because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking.

Today, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of this safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, the FDA is working with Pfizer to finalize a Medication Guide for patients.

Earlier this month, Pfizer had announced that it would be making warnings on suicide and other psychiatric problems on the Chantix label more prominent. The previous caution regarding these problems was far less prominent than the warnings for other various side effects, including nausea, changes in dreaming, constipation, and gas and vomiting that appeared on the Chantix label.

Chantix may have played a role in the death of musician Carter Albrecht. Albrecht, best known as a member of Edie Brickell and the New Bohemians, started taking Chantix in late August 2007. He was well liked in the community, and had no prior history of violence. Immediately, Albrecht began to complain of vivid, hallucinatory dreams — a common Chantix side effect. One night about a week after he started taking Chantix, Albrecht had a violent encounter with his girlfriend. The episode occurred after Albrecht had consumed a couple of alcoholic drinks. Albrecht’s girlfriend reported that he was confused, and did not recognize her. Before the night was over, Albrecht had been shot dead by a terrified neighbor on whose property he had trespassed.

Suicide Risks Must Now Be Measured in Drug Clinical Trails According to New FDA Policy

Thu, 24 Jan 2008 00:00:00 -0800

Drug companies will now have to monitor patients in clinical trials for signs of suicidal thoughts and behaviors, according to an article in The New York Times. The Food & Drug Administration (FDA) quietly decided to make the change to its clinical trial policy following the realization that antidepressants increased the risk that children and adolescents could become suicidal. Critics of the FDA say the policy change is long-over due, as many drugs – including anti-smoking medications, acne drugs and those that treat obesity – have been found to contribute or cause suicidal behavior in some patients long after they were approved.

The FDA is quite secretive in the way it oversees experimental medicines, and has not publicly announced the rule change. But according to the New York Times, in recent months, the agency has sent letters to drug makers requiring that they use such a scale. Merck, Sanofi-Aventis and Eli Lilly are all using a detailed suicide assessment in clinical trials being conducted now.

The suicide monitoring rule represents the biggest change in FDA policy in the last 16 years. The decision to require monitoring of clinical trial participants was prompted by the agency’s experience with antidepressants. Four years ago, researchers found that antidepressants could cause some children and teenagers to become suicidal. According to the New York Times, top FDA officials at first discounted the finding but commissioned researchers from Columbia University’s department of psychiatry, led by Kelly L. Posner, to reanalyze the drugs’ clinical trials. This work caused the drug agency and its experts to view the risk as real.

Then, while reviewing the Sanofi-Avantis’ application to approve rimonabant, a much-heralded obesity drug, the FDA found hints that it could be linked to an increased risk of suicide. Again, it asked Dr. Posner’s team to analyze its clinical trials. According to The New York Times, the assessment found that the drug doubled the risks of suicidal symptoms. In June, an FDA advisory committee voted unanimously that the agency reject rimonabant because of its psychiatric effects, and Sanofi-Aventis withdrew the application although the drug is sold in Europe.

Late last year, the FDA announced it would be reviewing the safety of Chantix, a smoking-cessation drug made by Pfizer, following reports that it caused suicidal thoughts and other psychiatric problems in users. Then, earlier this month, the results of a trial of Merck’s obesity drug, taranabant, were published showing similar psychiatric problems. At the same time other drugs, including those that treat epilepsy, seizures and mood disorders, showed similar side effects. According to The New York Times, FDA officials then realized that multiple classes of medicines might cause dangerous psychiatric problems.

It was then that the FDA decided to require drug makers to start monitoring clinical trials for suicide problems. To do so, those overseeing clinical trials will use a detailed questionnaire designed by Dr. Posner’s team to recognize suicide risks among participants.

But many critics of the FDA say the decision was long overdue. Medicines to treat acne, hypertension, high cholesterol, swelling, heartburn, pain, bacterial infections and insomnia can all cause psychiatric problems, effects that were discovered in most cases after the drugs were approved and used in millions of patients. If the FDA had recognized the suicide and psychiatric problems earlier, millions of patients could have been spared untold pain.

Chantix Blamed in Second UK Suicide

Mon, 21 Jan 2008 00:00:00 -0800

Chantix has been linked to a second suicide in the United Kingdom, just days after Pfizer announced that the stop smoking drug would bear stronger warnings regarding depression and suicide in the US. According to an article in the UK Daily Mail, a 36-year-old welder from Rossington in the UK hung himself shortly after completing a 13 week course of Champix –as Chantix is called in Britain. His death comes just months after Chantix was implicated in the suicide of a 39-year-old British TV producer who ended his life while being treated with Chantix.

Chantix, approved in the US in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the US Food & Drug Administration (FDA). It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. Prior to Pfizer’s announcement last week that it would be adding new warnings to the US version,, the Chantix package insert stated that psychotic and suicidal behavior were potential side effects. But that caution was far less prominent than the warnings for other various side effects, including nausea, changes in dreaming, constipation, and gas and vomiting that appeared on the Chantix label.

According to the family of Wayne Marshall, the father of two began taking Chantix in order to end a 20-cigarette-a-day habit. Marshall quickly became quiet and withdrawn, and on one occasion, his wife found him crying uncontrollably. His psychological problems got increasingly worse, and Marshall finally separated from his wife. Unaware that Chantix could be contributing to his problems, Marshall continued taking the drug as prescribed. According to Marshall’s wife, he had finished the drug course a week before she last saw him, but had started smoking immediately. A week later, he had taken his own life.

In the US, Chantix is currently undergoing an FDA safety review. The agency decided to conduct the review following reports describing suicidal thoughts and occasional suicidal behavior possibly linked to Chantix use. The FDA said that its preliminary assessment revealed that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear, the FDA said, because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking.

Similar problems have been seen among Chantix users abroad. The European Medicines Agency last month ordered improved warnings to patients over the twice-daily prescription medicine following reports it could lead to depression. Figures from the UK’s Medicines and Healthcare Products Regulatory Agency show one other patient has taken his life while on Chantix, two others have attempted suicide and there have been 60 other "suicidal-type suspected adverse reactions" reported.

Chantix Gets New Warning of Suicide, other Psychological Problems

Fri, 18 Jan 2008 00:00:00 -0800

Chantix, the stop smoking drug that has reportedly caused suicidal thoughts and other psychological problems in some users, will soon bear new warnings. Pfizer, the maker of Chantix, has chosen to include warnings about instances of depressed mood, agitation, suicidal thinking and suicidal behavior that have been reported among some users of the pill, even though the company claims that a “causal” link between the problems and Chantix has yet to be proven.

Such Chantix side effects may have played a part in the death of musician Carter Albrecht. Albrecht, best known as a member of Edie Brickell and the New Bohemians, started taking Chantix in late August 2007. Immediately, Albrecht began to complain of vivid, hallucinatory dreams — a common Chantix side effect. One night about a week after he started taking Chantix, Albrecht had a violent encounter with his girlfriend. Albrecht’s girlfriend reported that he was confused, and did not recognize her. Before the night was over, Albrecht had been shot dead by a terrified neighbor on whose property he had trespassed. It was the Albrecht death that first put a spotlight on possible Chantix problems.

Chantix, approved in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the Food & Drug Administration (FDA). It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. Prior to Pfizer’s announcement that it would be adding new warnings, the Chantix package insert warned that psychotic and suidical behavior were potential side effects. But that caution was far less prominent than the warnings for other various side effects, including nausea, changes in dreaming, constipation, and gas and vomiting that appeared on the Chantix label.

Today Chantix is getting a warning on its U.S. label that asks doctors to monitor for suicidal behavior, depressed mood and other psychological problems. While Pfizer has conceded that it has received various reports of psychological problems in people taking Chantix, the company won’t say how many. And Pfizer insists that people giving up smoking, or people who are smokers in the first place, tend more toward depression than their nonsmoking peers.

Pfizer’s decision to modify the Chantix label could be a move to head off regulatory action by the FDA. In November, the FDA announced that it was beginning a safety review of Chantix after Pfizer submitted several postmarketing cases to the agency describing suicidal thoughts and occasional suicidal behavior possibly linked to Chantix use. The FDA said that its preliminary assessment revealed that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

According to The Wall Street Journal, Chantix is used by more than five million patients and had sales of $603 million through the third quarter of 2007, in its first full year on the market.

Smoking Cessation Drug, Chantix, May Cause Serious Heart Side Effects

Tue, 01 Jan 2008 00:00:00 -0800

Chantix Marketing Campaign Ignores Reports of Suicide, Other Psychiatric Side Effects.

Mon, 31 Dec 2007 00:00:00 -0800

Chantix, an anti-smoking medication, continues to be touted as a “wonder drug” by its maker, Pfizer, Inc., despite the fact that it has been linked to 63 deaths and thousands of reports of psychiatric symptoms in the Unites States and Great Britain in the past year. Yet even though the US Food & Drug Administration (FDA) recently issued a warning about serious Chantix side effects, the dangerous medication is still being aggressively marketed with a campaign that features slickly produced TV commercials that make no mention of Chantix’s potential problems.

Chantix, approved in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. The Chantix label warns of various side effects, including nausea, changes in dreaming, constipation, gas and vomiting.    But those warnings are more prominent and easier to find than the fine print on the package insert that warns of the possibility of psychotic and suicidal behavior.

In November, the FDA said that it was beginning a safety review of Chantix after it received reports of 55 suicides and 199 suicidal thoughts possibly linked to Chantix use. The FDA said that its preliminary assessment revealed that many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear, the FDA said, because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking. At that time, the FDA recommended that doctors monitor patients taking Chantix for behavior and mood changes.

Similar problems with Chantix have also been reported in Britain, where the drug hit the market a year ago under the name Champix. The UK’s Medicines and Healthcare products Regulatory Agency, had received 1335 reports of patents suffering serious side effects, including seven deaths -- one of which was a suicide -- by December 18. Chantix was also linked to 748 cases of psychiatric problems including suicidal thoughts and depression, 819 gastrointestinal disorders and 70 heart disorders.

But smokers encouraged to ask their doctors about Chantix after seeing one of Pfizer’s engaging TV commercials or viewing its Chantix website would not know of the drug’s potential for psychiatric side effects. The side effects section of the Chantix website lists what Pfizer calls the drug’s “most common” side effects – nausea, sleep disturbance (trouble sleeping, changes in dreaming), constipation, gas, and vomiting – but makes no mention of suicide or suicidal thoughts.    The website only warns that “These are not all the side effects of Chantix. Ask your doctor or pharmacist for more information. ” But even the site’s section aimed at healthcare professionals makes no mention of suicide, suicidal thoughts or psychiatric side effects.

The FDA is expected to take several months to complete its Chantix safety review.   While that review is ongoing, many people will continue to use Chantix, possibly unaware of its potential to cause dangerous psychiatric side effects.

Chantix Blamed in British Suicide Case

Mon, 03 Dec 2007 00:00:00 -0800

Chantix, a medication meant to help people stop smoking, might be to blame for the suicide of a British man in October. According to the man's family, the victim, who had no prior history of depression, slashed his wrists and died just four weeks after starting treatment with Chantix. In November, the US Food & Drug Administration (FDA) announced that Chantix would undergo a safety review after it had been linked to psychological problems, including suicidal thoughts and erratic behavior in some users.

Chantix, approved in 2006, works by blocking nicotine receptors to the brain. Chantix, which is marketed by Pfizer, is the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. The Chantix label warns of various side effects, including nausea, changes in dreaming, constipation, gas and vomiting. But those warnings are more prominent and easier to find than the fine print on the package insert that warns of the possibility of psychotic and suicidal behavior.

According to published reports, Omer Jama, a 39-year-old British television editor, had begun taking Chantix to cure his 15-year-old addiction to cigarettes. Though estranged from his wife, Jama was said by his family to be upbeat and optimistic in his outlook. He had booked a holiday to Cuba with a friend just days previously to celebrate is 40th birthday, and the amateur golfer was still excited after winning a trophy at a recent tournament. Jama's brother told the British press that just days before the man had taken his own life, they had spoken. The brother said that Jama was happy, and excited about his upcoming trip. He made no hints, nor did Jama say anything to indicate that he was depressed and might be contemplating suicide. The family is convinced that Jama's suicide was a direct result of his Chantix use.

In the US, the FDA announced last month that it was reviewing several postmarketing incidents involving suicidal thoughts and occasional suicidal behavior linked to Chantix use. The FDA said it is currently reviewing these cases, along with a number of recent highly publicized incidents in the media. In Britain, the Medicines and Healthcare Regulatory Agency has received 839 reports of adverse reactions associated with Chantix. Forty-six were linked to depression, with 16 claiming to have suffered suicidal thoughts - although no suicides had been reported.

Anyone using or considering using Chantix must be aware of the reported psychological problems associated with its use. Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should also contact their doctors if they experience behavior or mood changes. Chantix users should also use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them, as the FDA is also evaluating reports of drowsiness in patients taking Chantix. These reports described patients who experienced drowsiness that affected their ability to drive or operate machinery.

Chantix Smoking Cessation Drug to Undergo Safety Review Following Reports of Suicide, Erratic Behavior

Tue, 20 Nov 2007 00:00:00 -0800

Chantix, a smoking cessation drug marketed by Pfizer, is undergoing a Food & Drug Administration (FDA) safety review following reports that linked the drug to psychological problems, including suicidal thoughts and erratic behavior. Chantix was recently implicated in the violent death of prominent Dallas musician Carter Albrecht who had been taking the medication on the night he was killed.

Chantix, approved in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. The Chantix label warns of various side effects, including nausea, changes in dreaming, constipation, gas and vomiting.    But those warnings are more prominent and easier to find than the fine print on the package insert that warns of the possibility of psychotic and suicidal behavior.

Such Chantix side effects may have played a part in the death of musician Carter Albrecht. Albrecht, best known as a member of Edie Brickell and the New Bohemians, started taking Chantix in late August 2007.   He was well liked in the community, and had no prior history of violence. Immediately, Albrecht began to complain of vivid, hallucinatory dreams -- a common Chantix side effect. One night about a week after he started taking Chantix, Albrecht had a violent encounter with his girlfriend.   The episode occurred after Albrecht had consumed a couple of alcoholic drinks. Albrecht’s girlfriend reported that he was confused, and did not recognize her. Before the night was over, Albrecht had been shot dead by a terrified neighbor on whose property he had trespassed.

According to the FDA, Pfizer recently submitted several postmarketing cases to the agency describing suicidal thoughts and occasional suicidal behavior possibly linked to Chantix use. The FDA said it is currently reviewing these cases, along with a number of recent highly publicized incidents in the media (presumably the Albrecht death).   The FDA said that its preliminary assessment revealed that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear, the FDA said, because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking.

The FDA is also evaluating reports from Pfizer of drowsiness in patients taking Chantix. The reports described patients who experienced drowsiness that affected their ability to drive or operate machinery.

The FDA is recommending that healthcare professionals monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes. Patients should use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.

Pfizer's Chantix Side Effects Blamed for Musician Carter Albrecht's Violent Death

Sun, 30 Sep 2007 00:00:00 -0700

There is quit a bit of speculation that the side effects of the ant-smoking drug Chantix might have been responsible for ending Carter Albrecht’s life. Carter Albrecht, a prominent Dallas musician died a violent death earlier this month.   In the week leading up to the tragedy, Albrecht had been reportedly suffering from vivid, hallucinatory dreams; a Chantix side effect.

Albrecht, a member of rock group Edie Brickell and the New Bohemians, was on the verge of promising solo music career. He had started taking Chantix a week before he died.   The drug Chantix, approved by the Food & Drug Administration (FDA) just last year, is meant to assist people who want to stop smoking.   Albrecht was reportedly desperate to quit, as a doctor had told him smoking would damage his singing voice.

According to the Dallas Morning News, Albrecht began complaining of vivid dreams as soon as he started using Chantix. While the Chantix labels list “changes in dreaming” as a possible side effect of the drug, Albrecht’s girlfriend told the newspaper that what happened to him went far beyond that. She said Albrecht would awaken in the middle of the night, not sure that what he had experienced was real or a dream.

One evening, after Albrecht had a few cocktails, he started lashing out violently towards his girlfriend – something she said had never occurred before.   Albrecht’s girlfriend told the Morning News that he seemed confused and terrified, and looked at her as though he did not recognize her. Somehow, Albrecht ended up at the home of a neighbor, banging violently on the back door. A call was made to 911, but before the police arrived the terrified neighbor had fired a warning shot from his rifle, which accidentally hit and killed Albrecht.

Albrecht’s girlfriend told the Morning News that she is convinced that Chantix played a roll in his death. And since the drug was approved last year, evidence is emerging that it could very well cause side effects similar to what Albrecht suffered. Since the drug was approved, reports of users suffering from suicidal thoughts and bizarre violent behavior have been cropping up in media outlets. One Chantix user told the Morning News about feeling as though he wanted die after having had a couple of drinks. Once this man stopped using alcohol when he took Chantix, he said the suicidal thoughts ended.

Side effects like nausea, changes in dreaming, constipation, gas and vomiting are prominently listed on the patient handout that pharmacies include with Chantix prescriptions. But only in small print in the original box insert is there mention of rare episodes of psychotic and suicidal behavior.

Chantix affects the central nervous system, as does alcohol. One addiction expert told the Morning News that it would not be unusual for a drug like Chantix to react poorly with alcohol. And such an adverse reaction might not be discovered during clinical trials of a drug, as ethical considerations prevent researchers from studying a drug’s interaction with alcohol.

Pfizer, the maker of Chantix, claims that there is no link between the drug and violent behavior, but the FDA said it would be investigating the role it might have played in Albrecht’s death. Anecdotal evidence that this drug does causes serious behavioral changes in some users is starting to pile up. Until more studies are done to determine the safety of Chantix, caution should be used when taking it. And at the very least, users should avoid all alcoholic drinks while they are taking Chantix.

Chantix Lawyer Zyban Lawsuit Side Effects

Sun, 30 Sep 2007 00:00:00 -0700

Chantix and Zyban Injury Lawyers

Keywords: Chantix Zyban Side Effects

If you take Chantix or Zyban in an effort to quit smoking and have experienced psychiatric problems, you should know that these drugs could be to blame. Chantix and Zyban have been linked to serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts. These side effects have been so serious that in July 2009, the Food & Drug Administration (FDA) mandated that a Black Box Warning - the agency's most serious safety notice - be added to the label of Chantix and Zyban highlighting their association with mental health problems.

We are currently investigating Chantix and Zyban lawsuits on behalf of people who have suffered serious mental health problems as a result of these medications. Because Chantix and Zyban did not come with stronger warnings about their psychiatric side effects, it is possible that many users have no idea that mental health problems they experienced may have been caused by these drugs.

If you or someone you love suffered from serious mental health issues, including depression or suicidal thoughts, while taking Chantix or Zyban, you may be entitled to compensation. Please contact one of our Chantix or Zyban injury lawyers right away to protect your legal rights.

Chantix and Zyban

Chantix is a smoking cessation medication marketed by Pfizer, Inc. that was approved by the FDA in 2006. Chantix works by blocking nicotine receptors, thereby reducing cravings for and decreases the pleasurable effects of cigarettes and other tobacco products. Chantix was the first such nicotine receptor partial agonist approved by the FDA. It is an alternative to other smoking cessation drugs and nicotine replacement therapy.

Shortly after it was introduced to the market, some Chantix patients reported that they had experienced strange side effects, including erratic behavior, suicidal thoughts and depression, while taking the drug. In November 2007, the FDA announced that it had begun a Chantix safety review because of these reports.

In 2008, Pfizer elevated the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, wanted the FDA to go further and highlight the Chantix suicide risk with a Black Box Warning.

Zyban, manufactured by GlaxoSmithKline, was originally marketed as an antidepressant under the name Wellbutrin. In 1997, the FDA approved Zyban to be used as a quit smoking aid, and since then, it has become a popular method to help smokers kick the habit. Zyban, when used in combination with other nicotine replacement therapies (NRT's), such as the nicotine patch or nicotine gum, increases the chances for long term success with smoking cessation.

Chantix and Zyban Black Box Warning

In July 2009, the FDA announced it had mandated a Black Box Warning for the labeling of Chantix and Zyban to highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

The FDA’s request for the additional warnings was based on a review of reports submitted to the agency’s Adverse Event Reporting System since the time the products were marketed and on an analysis of information from clinical trials and scientific literature.

The analyses revealed that some who have taken Chantix and Zyban have reported experiencing unusual changes in behavior, become depressed, or had their depression worsen, and had thoughts of suicide or dying. According to media reports, the FDA had received 98 reports of suicide among patients taking Chantix and 188 reports of attempted suicide, and 14 suicides and 17 suicide attempts among patients taking Zyban.

In many cases, the FDA said the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped.

Neither Chantix nor Zyban contain nicotine and some of these symptoms may be a response to nicotine withdrawal, the FDA said. People who stop smoking may experience symptoms such as depression, anxiety, irritability, restlessness, and sleep disturbances. However, some patients who were using these products experienced the reported adverse events while they were still smoking, the FDA said.

In addition to the Boxed Warning, the FDA also requested more information in the Warnings section of the prescribing information and updated information in the Medication Guide for patients that further discuss the risk of mental health events when using Chantix or Zyban.

Legal Help for Victims of Chantix or Zyban Side Effects

If you or someone you love has used Chantix or Zyban to quit smoking, and experienced serious mental health problems, you may be eligible to file a Chantix or Zyban lawsuit. Please fill out our online form or call 1 800 LAW INFO (1-800-529-4636) as soon as possible to discuss your case with one of our Chantix or Zyban injury lawyers.