Yourlawyer.com (Provigil News)

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.

Study: Provigil Might Be Addictive

Thu, 19 Mar 2009 00:00:00 -0700

Narcolepsy drug Provigil has been found to have potential links to addiction, according to recent U.S. study conducted by drug abuse experts, Reuter’s reports.

Cephalon Inc.’s Provigil—generically known as modafinil and approved since 1999—is being used with increased frequency to enhance brain performance, said Reuters, but the narcolepsy drug can be addictive in some people using the drug for this off-label purpose. The study, conducted as a pilot on 10 healthy men—aged 23 to 46—taking Provigil at normal doses, revealed increases in dopamine levels that occurred in the part of the brain that is active when other abusive drugs are taken, noted Reuters. USA Today reported that the men were given either 200 milligrams of modafinil, which is the recommended daily dose prescribed for treating sleep disorders, or 400 milligrams.

According to USA Today, the chemical dopamine is a neurotransmitter that carries messages from nerve cells to other nerve cells or tissues. The chance for abuse increases when dopamine has been boosted.

Provigil was approved by the Food & Drug Administration for narcolepsy-related excess sleepiness, sleep apnea, and shift work disorder. But it is used off-label for weight loss, attention deficit hyperactivity disorder (ADHD), fatigue, and depression, said Reuters, noting that its 2008 sales exceeded $852 million. Recently a trend in Provigil off-label use has been seen on college campuses to improve cognitive performance, said Reuters. This “smart-drug” trend led Dr. Nora Volkow, director of the National Institute on Drug Abuse, to review Provigil, said Reuters "The main problems that we see,” Volkow told Reuters, “are not the people who are properly prescribed the medication, but individuals who may be misusing and abusing the medication."

Late last year, Dr. Volkow said she found that surveys taken at college campuses revealed that drugs such as Provigil and Novartis' Ritalin (methylphenidate) were being used not only by students, but by professors and other individuals because of the medication’s so-called “brain-boosting” properties, said Reuters. "The message for individuals who are taking this medication who want cognitive enhancement is that its use could result in very serious cognitive effects, including addiction," noted Volkow. FiercePharma cited an earlier piece in Nature in which some scientists admitted Provigil use to increase productivity.

"It has the signature that it could potentially be addictive," said Dr. Volkow, whose study appears in the Journal of the American Medical Association, reported Reuters, adding "Studies have shown consistently that all of the drugs of abuse ... have a common effect of increasing dopamine in this area, in the nucleus accumbens … that is believed to be crucial for their reinforcing effect and ultimately their underlying potential for producing addiction," warned Volkow in a telephone interview with Reuters. The team said the results called for more research.

Provigil was believed to be less likely to cause addiction over other stimulants because it was thought not to increase dopamine levels, said FiercePharma; however, the researchers, who used PET (positron emission tomography) scanning in their study, found Provigil does raise such levels. Volkow warned that such “smart drugs” have been known to spark brief psychotic episodes, adding that there is scant evidence pointing to improved cognition.

Cephalon to Pay $425 Million to Settle Illegal Marketing Charges Involving Actiq, Provigil and Gabitril

Tue, 30 Sep 2008 00:00:00 -0700

Cephalon Inc. has reached a settlement with federal prosecutors over charges that the drug maker illegally marketed its narcotic painkiller Actiq, as well as two other drugs, Provigil and Gabitril. In addition to paying a fine of $425 million, Cephalon will plead guilty to a criminal misdemeanor for the illegal off-label marketing of its drug.

Actiq, sold as a lozenge on a stick, has been implicated in over 120 fatalities, including the deaths of two children who thought the drug was candy. Actiq contains fentanyl, a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose. While Actiq was only approved for treating pain in cancer patients, a November 2006 Wall Street Journal investigation found that 80-percent of patients taking Actiq did not have cancer.

Once a drug has been approved by the Food & Drug Administration (FDA), doctors are free to prescribe it as they see fit. However, drug companies are prohibited from advertising a drug’s off-label uses.

According to U.S. prosecutors, Cephalon marketed Actiq to doctors as a treatment for migraines and injuries. The company used lavish physician-education conferences and a compensation and bonus structure to encourage off-label use of Actiq. The company also had its sales people market Actiq to doctors who did not treat cancer patients. As a result of these illegal practices, sales of Actiq rose from $50 million in 2001 to $500 million in 2006.

Prosecutors said that Cephalon used the same tactics to illegally market the epilepsy drug Gabitril as a treatment for anxiety, insomnia and pain; and promoted the use of the narcolepsy medication Provigil for fatigue and other ailments.

The $425 million settlement includes a $375 million civil settlement, a $40 million criminal fine and $10 million in criminal forfeiture, prosecutors said. A share of the settlement - $46.5 million – will go to former Cephalon sales representatives who acted as whistleblowers and reported the company’s illegal marketing practices to authorities. Most of the settlement will be used to reimburse state Medicare plans. In addition to the fine, Cephalon will also pay more than $12 million in interest.

While the company has agreed to plea to a misdemeanor charge, prosecutors had considered levying a more serious felony charge against Cephalon. Prosecutors said they did not want a felony charge to hinder the company’s ability to sell the drugs to people who truly needed them.

Provigil Needs Stronger Warning Against Use In Children, FDA Panel Says

Thu, 29 Nov 2007 00:00:00 -0800

Provigil, a drug used to treat excessive sleepiness, should bear a stronger warning on its label that the medication is not approved for use in children under the age of 16, a Food & Drug Administration (FDA) panel said yesterday. While Provigil, manufactured by Cephalon, is not approved for use in children, it has been prescribed to treat a variety of conditions in kids quite frequently.

Approved by the FDA in 1998, Provigil has been used to treat the excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. However, it is known that doctors also prescribe Provigil for a number of off-label uses in both adults and children. In many cases, Provigil is used in the treatment of Attention Deficit Hyperactivity Disorder, Multiple Sclerosis and depression. It is estimated that as much as 90% of all Provigil prescriptions are written for off-label use. Such off-label use is not illegal, as doctors are free to prescribed approved drugs in any way they see fit. However, drug companies are not allowed to market a medication based on off-label use. In 2004, Cephalon was investigated for allegedly promoting off-label uses for Provigil.

While the current label does note that Provigil has not been approved for children under 16, several FDA advisory panel members said they were concerned about that off-label use and wanted to send a stronger signal that the drug shouldn't be used in children. The FDA advisors voted 12-0 that more forceful language stating that Provigil is not recommended for use in children is necessary.

In October, the FDA updated the Provigil label to warn of several dangerous side-effects associated with its use. That updated Provigil label says that the drug has been associated with a number of serious skin disorders, including Stevens-Johnson Syndrome, a sometimes life-threatening hypersensitivity complex affecting the skin and the mucous membrane. Provigil has also been linked to Toxic Epidermal Necrolysis, another life-threatening, and usually drug-induced, dermatological condition that is characterized by the detachment of the top layer of skin from the lower layers of the skin all over the body. Other conditions linked to Provigil include Drug Rash with Eosinophilia and Systemic Symptoms, a severe, unexpected reaction to a drug, which affects several organ systems at the same time; and Angioedema, a swelling beneath the skin similar to hives. Patients are warned to stop using Provigil at the first sign of a skin rash and contact their doctors immediately. Patients who experience any swelling of the face, eyes, lips, tongue, larynx or experience difficulty swallowing or breathing, or suffer from hoarseness should also stop using Provigil.

In addition to the skin disorders, the FDA has warned that Provigil use has been connected to severe psychiatric symptoms, including anxiety, mania, hallucinations, and suicidal thoughts. The new Provigil labeling cautions physicians against prescribing the drug to people with a history of mania or depression, and says that Provigil use should be halted if a patient develops any psychiatric symptoms.

The FDA is not obligated to follow the recommendations of advisory panels, but it most cases the agency does.

Provigil Warnings Added For Serious Skin Rashes, Psychiatric Problems

Thu, 25 Oct 2007 00:00:00 -0700

The Provigil label has been updated to include warnings about life-threatening skin rashes and psychiatric problems linked to the drug. The Food & Drug Administration (FDA) asked Cephalon, Inc., the maker of Provigil, to add the warnings after it had received multiple reports of skin rashes, including a disorder called Stevens-Johnson Syndrome, and psychiatric symptoms occurring in people who took Provigil, including children.

Approved by the FDA in 1998, Provigil has been used to treat the excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. The military sometimes uses Provigil to keep pilots and soldiers awake during combat situations, and the drug is known to enhance short-term memory. Provigil is also used off-label to treat other conditions such as “chemo brain”, a type of cognitive impairment that often affects cancer patients undergoing chemotherapy.

The new Provigil warnings say that the drug has been associated with a number of serious skin disorders, including Stevens-Johnson Syndrome, a sometimes life-threatening hypersensitivity complex affecting the skin and the mucous membrane. Provigil has also been linked to Toxic Epidermal Necrolysis, another life-threatening, and usually drug-induced, dermatological condition that is characterized by the detachment of the top layer of skin from the lower layers of the skin all over the body. Other conditions linked to Provigil include Drug Rash with Eosinophilia and Systemic Symptoms, a severe, unexpected reaction to a drug, which affects several organ systems at the same time; and Angioedema, a swelling beneath the skin similar to hives.

The new Provigil label says that patients should stop using the medication at the first sign of a skin rash and contact their doctors immediately. Patients who experience any swelling of the face, eyes, lips, tongue, larynx or experience difficulty swallowing or breathing, or suffer from hoarseness should also stop using Provigil.

In addition to the skin disorders, the FDA has warned that Provigil use has been connected to severe psychiatric symptoms, including anxiety, mania, hallucinations, and suicidal thoughts. The new Provigil labeling cautions physicians against prescribing the drug to people with a history of mania or depression, and says that Provigil use should be halted if a patient develops any psychiatric symptoms.

Finally, the label warns that Provigil has not been approved for use in children, which is an off-label use of the medication. It is known that doctors prescribed Provigil for a number of off-label uses, including the treatment of Attention Deficit Hyperactivity Disorder, Multiple Sclerosis and depression. It is estimated that as much as 90% of all Provigil prescriptions are written for off-label use. Such off-label use is not illegal, as doctors are free to prescribed approved drugs in any way they see fit. However, drug companies are not allowed to market a medication based on off-label use. In 2004, Cephalon was investigated for allegedly promoting off-label uses for Provigil. The company has also been investigated for promoting its painkillers Fentora and Actiq in the same manner.

Provigil Side Effects Lawsuit Lawyer SJS

Thu, 25 Oct 2007 00:00:00 -0700

Provigil Side Effects Lawsuit Lawyers

Provigil Linked to Stevens-Johnson Syndrome (SJS)
In October 2007, the label of Provigil was updated to include warnings regarding the occurrence of serious rashes, including Stevens-Johnson Syndrome (SJS), hypersensitivity reactions, and psychiatric symptom associated with its use. According to the Food & Drug Administration (FDA) rare cases of serious or life-threatening rash, including Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms have been reported in adults and children in worldwide. Angioedema and multi-organ hypersensitivity reactions were also associated with Provigil.

Provigil was approved by the FDA in 1998 to treat the excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. Provigil is sometimes given as a performance enhancement by the military for pilots and soldiers in combat situations. Provigil enhances short-term memory and lets users stay awake for extended periods. Provigil was never approved to treat pediatric patients.

Provigil Associated with Life-Threatening Skin Rashes
According to the FDA, Cephalon, Inc, the manufacturer of Provigil, agreed to update the drug’s label to include warnings that Provigil had been associated with life-threatening skin rashes, including:

Stevens-Johnson Syndrome, a severe and life-threatening condition. Though not well understood, Stevens-Johnson Syndrome is thought to be a hypersensitivity complex affecting the skin and the mucous membrane.
Toxic Epidermal Necrolysis, another life-threatening, and usually drug-induced, dermatological condition. It is characterized by the detachment of the top layer of skin from the lower layers of the skin all over the body.
Drug Rash with Eosinophilia and Systemic Symptoms, a severe, unexpected reaction to a drug, which affects several organ systems at the same time. It most commonly causes the combination of a high fever, a skin rash and inflammation of one or more internal organs including the liver, kidneys, lungs and/or heart.
Angioedema, the rapid swelling of the skin, mucosa and submucosal tissues

The new Provigil warnings advised that patients should discontinue use of the drug at the first sign of any skin rash. It also said that patients should stop using Provigil if they experienced swelling of the face, eyes, lips, tongue, larynx or experience difficulty swallowing or breathing, or suffer from hoarseness.

Provigil and Psychiatric Symptoms
In October 2007, the Provigil label was also updated to include information on psychiatric symptoms associated with its use. Psychiatric problems, including anxiety, mania, hallucinations, and suicidal thoughts have been reported in patients using Provigil. The new label warnings advised that cautione should be used in prescribing Provigil to patients with a history of psychiatric problems like psychosis, depression or mania. The new warnings also said that patients should cease taking Provigil immediately if they develop any of these psychiatric symptoms.

Provigil Side Effects SJS Lawsuit Attorneys
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