http://www.yourlawyer.com/topics/overview/fentora_overdose Sat, 21 Nov 2009 20:33:30 -0800 pixel-app en http://www.yourlawyer.com/articles/read/16021 Mon, 09 Feb 2009 00:00:00 -0800 http://www.yourlawyer.com/articles/read/16021
"We know that these drugs have important therapeutic uses," said Douglas Throckmorton, MD, the Food and Drug Administration's (FDA) deputy director for Drug Evaluation and Research. "We also know that there's abuse. There are overdoses. There's diversion that we don't want to happen," he added, said AMedNews.

Some states have established prescription drug monitoring programs, some medical societies have conducted studies and urged more education, and, now, the FDA and the Centers for Disease Control and Prevention (CDC) will be working together to look at the trend in accidental opioid overdoses, AMedNews reported.

Meanwhile, Fentora, a powerful narcotic pain killer in the opioid class is the subject of three separate investigations and has been linked to four deaths, which prompted Cephalon Inc., Fentora’s maker, to issue warning letters to doctors about the deaths, which it claims were due to improper patient use.  "Physicians need a practice environment that allows for the appropriate use of controlled substances, including those used for pain management, while minimizing inappropriate use and diversion," said Edward L. Langston, MD, immediate past chair of the AMA Board of Trustees.  For instance, Fentora  and  Actiq—both in the fentanyl family, highly addictive, and 80 times more potent than morphine—received FDA approval for use in cancer patients only, but are known to be prescribed “off-label” for headaches and back pain.  Fentanyl is considered a Class II substance by the Drug Enforcement Administration (DEA), meaning it is associated with a high potential for abuse and a risk for fatal overdose.

The upward trend in opioid use for non-cancer chronic pain began in recent years as did the related rise in misuse and negative effects, noted AMedNews, which added that accidental overdose deaths from narcotics or hallucinogens in the 15-64 years age range rose 5,921 in 1999 to 10,829 in 2005, an 83 percent increase.  Unintentional overdoses not resulting in fatality saw a 44 percent increase from 376,611 to 542,372 accidents in the same time frame and within the same age group.  AMedNews said that opioids were the prevailing factor in all the incidences.

According to the FDA, it and the CDC will support research efforts, by way of grants, with opioids being the main focus, said AMedNews.  The CDC will provide $350,000 in funding to two grantees; the money to be provided by the FDA remains unknown at this time.  "These grants will help us identify promising strategies to combat this epidemic of prescription drug overdoses," said Len Paulozzi, MD, MPH, a medical epidemiologist in the CDC's unintentional injury prevention division at its National Center for Injury Prevention and Control.  "The prescription drug abuse problem is enormous and ... it seems to be getting worse," he added, quoted AMedNews.   "Those overdosing on opioids are just showing up in the medical examiner's office dead, but a piece of solving this problem is figuring out how to get poison centers involved," said William Hurley, MD, the WPC medical director; the WPC is applying for one of FDA/CDC grants, said AMedNews.

One of the contributing factors to the rise in opioid overdose and deaths is doctor shopping, which according to the Daily Progress, is the practice of moving from one doctor or emergency room to another to collect prescriptions and ensure a supply of drugs when one doctor or facility catches on to the abuse.  One of the drug clinics cited in the piece said that the vast majority of its patients—a whopping 95 percent—come in because of opioid addictions.

]]> http://www.yourlawyer.com/articles/read/14826 Fri, 25 Jul 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14826
The first cluster of Fentanyl overdoses appeared in 2005 in Chicago; by 2006, “clusters were identified in Philadelphia, Detroit, and other cities.”  Over time, hundreds of Fentanyl-related deaths were reported; this week’s tally from the Centers for Disease Control and Prevention (CDC) reports 1,013 deaths from early April 2005 through late March 2007.  "This was really an epidemic," said Dr. Steven Marcus, executive director of New Jersey's poison control center and a co-author of the new report.

Health officials say the increase in overdoses seems to have ended, in part due to law enforcement's shutdown of a Toluca, Mexico Fentanyl operation in May 2006, according to Dr. T. Stephen Jones, the study’s lead author.  But some deaths from illegal Fentanyl still occur.  "It almost disappeared entirely. The shutting down of the Toluca facility was probably a major factor," said Jones, a consultant retired from the CDC.  The new report is being published this week in a CDC's Morbidity and Mortality Weekly report.

Fentanyl is a prescription painkiller typically prescribed via a patch to cancer patients.  Because Fentanyl is also ‘a powerful, euphoria-inducing narcotic—30-50 times more potent than heroin—it is often used illegally for it’s street drug effects with heroin addicts possibly unaware that the deadly version of Fentanyl is included in their injections.  Illegal Fentanyl is “sold as a powder, often mixed with cocaine or heroin, and sometimes used as a heroin replacement.”  As far back as the 1980s there have been reports of isolated Fentanyl-related outbreaks involving deaths in addicts.  For instance, the famed “China White" outbreak is best noted for its severe, deadly reactions.  That outbreak involved users dropping “dead with needles still in their arms.”

In the more recent outbreak, which seems to have been initiated in Chicago, those patients who recovered from Fentanyl overdoses reported that they had received “free heroin in orange and pink plastic bags by new drug dealers trying to attract more customers.  The Chicago cases are summarized in the July issue of Clinical Toxicology.”

It was when an outbreak occurred in Camden, New Jersey in April 2006 that Marcus notified federal officials.  Marcus says the investigation was “unusual” because some health officials were reticent to devote resources on illicit drug fatalities.  "The response when I deal with public health officials is, 'Drug abuse is a dangerous habit, and drug abusers know it's a dangerous habit, so why are we making a big deal out of it?'" Marcus said.

Meanwhile, the report separates deaths by those due to illegally made Fentanyl and those due to illegal use of pharmaceutical Fentanyl.  Because Medical examiners cannot differentiate between the two, investigators used information from the scenes, among other information, to separate the two groups.  Also of note, the figures in this week’s report only cover New Jersey and Delaware and the “cities of Chicago, Detroit, Philadelphia, and St. Louis.”    "It's an incomplete picture," Jones said.

]]> http://www.yourlawyer.com/articles/read/14348 Wed, 07 May 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14348 Fentora hit a snag yesterday, as a Food & Drug Administration (FDA) panel voted 17-3 against the proposal.  Panel members said they were concerned that expanding the use of Fentora beyond cancer patients would lead to more misuse of the highly-addictive drug, which has already been blamed for many overdose deaths. Currently, about 20,000 people use Fentora, but some expect that with expanded approval, that number would balloon to ten million.

Fentora was approved in 2006 only for treating pain in cancer patients. It is intended for patients who experience breakthrough pain because they have developed tolerances to other opiate painkillers. Fentora 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 Fentora is only approved for cancer patients, it is known that as many 80 percent of people using it do so “off-label” to headaches and back pain. Once a drug has been approved by the FDA doctors are free to prescribe it as they see fit, but drug companies are legally barred from promoting off-label use.  Cephalon has been the subject of several investigations into off-label promotion of Fentora and other narcotic painkillers. In November, the company reached an agreement with the US Department of Justice to pay $425 to settle charges stemming from the illegal marketing of Fentora, as well as another of its narcotic painkiller, Actiq.

Cephalon has reported five patient deaths due to negative reaction or overdose of the drug. In September 2007, the FDA issued a public health advisory, warning that several Fentora-related deaths had occurred in patients who were prescribed the drug for off-label use. The FDA advisory warned that Fentora should not be used for any other conditions including migraines, post operative pain or pain due to injury.

Despite the overdose dangers, Cephalon has continued to push the FDA to expand Fentora's approved uses.  At yesterday's advisory panel meeting, however, FDA scientists testified that widening approval of Fentora could have dangerous effects because of the risks for improper prescribing and abuse of the drug, which is more potent than other pain medications.  

Patients suffering from ailments like back pain and migraines already have access to many approved narcotics, causing many panelists to question the need for expanded Fentora approval.  "How many people are we going to help with the release of this product and how many are we going to hurt?" asked panel member Dr. Charles Cortinovis, of the Veterans Administration Hospital in Pittsburgh. "In my mind it is very scary to release such a large amount of powerful opiate into the American population."

Cephalon tried to ease fears over Fentora misuse by proposing a plan that would require pharmacists to electronically confirm a patient's symptoms before dispensing the drug.  While some panelists like that idea, they want Cephalon to perform more studies to prove its plan will help reduce medication errors and abuse of the drug. Several panel members also said Cephalon should conduct more studies to determine if Fentora offers more benefits to non-cancer patients than other painkillers already approved for such conditions.

The FDA is expected to make its final decision on Fentora by mid-September. Though the agency is not bound by the recommendations of advisory panels, it usually follows them.

]]> http://www.yourlawyer.com/articles/read/14335 Mon, 05 May 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14335 Fentora, a cancer pain drug, to non-cancer patients.  An FDA official said Fentora use in noncancer patients could have "devastating effects.  Cephalon continues to seek FDA approval to promote Fentora—fentanyl buccal—for sudden pain in noncancer patients with an opioid tolerance.

Last September, Cephalon submitted a request to the FDA seeking approval to market Fentora for breakthrough pain management in opioid-tolerant noncancer patients.  Given that Cephalon’s illegal marketing practices have been under constant scrutiny in recent years and the FDA issued a pubic warning over Fentora following reports its use led to breathing problems, deaths, and other serious complications, this was an odd request.

"We are concerned that the sponsor's request to expand the current indication for Fentora ... may greatly increase the prescribing of this product which may increase the availability of the product for diversion, abuse, and misuse," wrote Bob Rappaport, head of the FDA's Division of Anesthesia, Analgesia, and Rheumatology Products.  Rappaport added Fentora could "increase the incidence of accidental exposures which, due to the potency of the product, could potentially have devastating effects."

In 2006, the Wall Street Journal investigated Cephalon’s marketing of Actiq—Cephalon's other fentanyl drug sold in a lollipop form—and discovered 80 percent of patients prescribed Actiq were not cancer patients and Cephalon frequently focused marketing of Actiq to noncancer physicians in sports medicine and family practice specialties.  That same year, the Connecticut Attorney General discovered Cephalon illegally marketed Actiq for off-label use and set high sales quotas that could only be met through off-label dispensing.  Cephalon’s marketing of Fentora had also been under investigation by the US Attorney in Philadelphia as well as by Congress.  Actiq has been linked to over 120 deaths.  In the case of Fentora, illegal marketing has been linked to four deaths, none of which occurred in cancer patients. Cephalon admitted some of these deaths were due to off-label use.

Fentora and Actiq are FDA-approved only for use in cancer patients for break-through pain—pain that occurs quickly, is severe, and is of short duration.  Fentora is contraindicated for noncancer-related pains and for cancer patients intolerant to or not undergoing constant opioid therapy; the drug is indicated for a very specific population, is a faster acting version of Actiq, and is not a generic version of any opioid-containing drug.  Because Fentora is dosed to deliver higher amounts of fentanyl—a highly addictive opiate 80 times more powerful than morphine—it is never to be substituted for any other drug since misuse at any dose can—and has—resulted in death.  

The FDA is conducting an advisory meeting tomorrow with a panel of external experts regarding whether wider Fentora use should be approved.  The FDA said it received reports Fentora was incorrectly prescribed, given at wrong doses, and that tablets were inappropriately substituted by doctors and pharmacists for Actiq.  Cephalon told reporters, "There is no evidence that Fentora poses risks of abuse and diversion greater than other opioids."  Cephalon said it expects the FDA to make its final decision by September 13.

]]> http://www.yourlawyer.com/articles/read/13649 Wed, 09 Jan 2008 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13649 Fentora, are powerful painkillers that are increasingly being prescribed in emergency rooms.  A new study finds that white patients are more likely to receive the pain killing medications than minorities, possibly due to stigmas related to addiction.  Since the 1990s, as health officials began focusing on under-treated pain, a growing number of patients have been given opioids in a variety of medical settings, the study noted.  But the researchers, whose report appears in the January 2nd Journal of the American Medical Association, wanted to see if the increase extended to emergency rooms and also wanted to know if there was still a tendency among doctors to withhold opioid drugs from blacks and nonwhite Hispanics.  According to the study, the tendency still exists.

Dr. Mark J. Pletcher of the University of California, San Francisco led the research.  Pletcher and his team based their findings on a review of over 150,000 pain-related emergency room visits nationwide over 13 years and discovered in 1993, 23 percent of patients treated in emergency rooms complaining of pain were given opioids; in 2005, the figure was 37 percent.  When nonwhites are treated, figures change.  Researchers found if two groups of one dozen patients sought treatment for pain—one group all white; the other all minority—one fewer patient in the minority group would receive medication.  Researches said white patients could be given opioids too often, but sounded doubtful, saying, “A more plausible explanation for our findings invokes a true disparity in prescribing, with differential under-treatment of pain in minority patients.”

This is not the only issue of disparate treatment in U.S. hospitals based on.  A study published last week revealed that nearly one-third of all patients experiencing misfiring or quivering hearts in U.S. hospitals do not receive life-saving defibrillator shocks within the critical first two minutes of cardiac arrest.  This, despite the fact that The American Heart Association recommends stopped hearts be shocked within the first two minutes.  The study confirming the importance of the two-minute period for survival was published in the New England Journal of Medicine, which also ran an accompanying editorial piece indicating a person might be better off suffering cardiac arrest in a casino rather than a hospital.  Researchers from 369 hospitals in the National Registry of Cardiopulmonary Resuscitation found that being black or having a cardiac arrest outside of regular weekday working hours also significantly delayed the time it took for hospital workers to shock the heart.  Paul Chan of the Mid-America Heart Institute in Kansas City, Missouri led the study in the New England Journal of Medicine.

Disparity appears among class groups as well.  A recent study found 72 percent of those receiving free drug samples from their physicians had income in excess of 200 percent above the poverty level, while 28 percent had income below poverty level.† William Shrank, a physician at Boston's Brigham and Women's Hospital who studies pharmaceutical use in large populations, said the study helps debunk the assertion that drug samples help the needy.

]]> http://www.yourlawyer.com/articles/read/13315 Tue, 13 Nov 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/13315 Food & Drug Administration (FDA) seeking approval to market Fentora—fentanyl buccal—for the management of breakthrough pain in opioid-tolerant noncancer patients.  An odd request given that Cephalon’s illegal marketing practices have been under constant scrutiny in recent years.  In fact, Cephalon just reached an agreement with the US Department of Justice to pay $425 to settle charges stemming from the illegal marketing of Fentora, as well as another of its painkiller, Actiq

In 2006, the Wall Street Journal investigated Cephalon’s marketing of Actiq—a pain-management cancer medication—and discovered that 80 percent of patients prescribed Actiq were not cancer patients and that Cephalon frequently focused marketing of Actiq to noncancer physicians in the sports medicine and family practice specialties.  That same year, the Connecticut Attorney General discovered that Cephalon marketed Actiq for off-label use—purposes other than the drug’s intention—and set high sales quotas that could only be met through off-label dispensing.  Of note since Actiq has been linked to over 120 deaths.

Most recently, Cephalon’s marketing of Fentora—a potent cancer pain management drug—has been under investigation by the US Attorney in Philadelphia, the Connecticut Attorney General, and Congress.

Both Fentora and Actiq are FDA-approved only for use in cancer patients for break-through pain, a type of pain that that occurs quickly, is severe, and is of short duration. Fentora is contraindicated for noncancer-related pains and for cancer patients intolerant to or not undergoing constant opioid therapy.  The drug is indicated for a very specific population, is a faster acting version of Actiq, and is not a generic version of any opioid-containing drug.  Because Fentora is dosed to deliver higher amounts of the opioid fentanyl—a highly addictive opiate 80 times more powerful than morphine—it is never to be substituted for any other drug since misuse at any dose can and has resulted in death.

Doctors are free to prescribe FDA-approved medications as they see fit, including off-label.  It is off-label marketing of FDA-approved medication—marketing for uses not approved by the FDA—which is illegal.  Off-label marketing is misleading and, in the case of Fentora, has been linked to four deaths, none of which occurred in cancer patients. Cephalon admitted that some of these deaths were the result of off-label use.  The FDA reports that other Fentora deaths have been due to doctors prescribing higher-than-recommended doses of the drug, a dangerous situation in light of the fact that over 80,000 prescriptions have been written for Fentora, a suspiciously large amount given the very limited population able to take the drug.

The FDA has mandated Cephalon to strengthen drug warnings and improve dosing instructions and education plans.  And although Cephalon has denied it marketed Fentora and Actiq outside their indication and claims the problems are a result of improper prescribing, they have agreed to pay $425 million to settle the US Justice Department investigation; agreed to a misdemeanor violation of the US Food, Drug, and Cosmetic Act; and will enter into a corporate-integrity agreement with the Department of Health and Human Services.

But, none of this stopped Cephalon from submitting their request to the FDA seeking approval to continue marketing Fentora for noncancer pain management.

]]> http://www.yourlawyer.com/articles/read/13151 Wed, 26 Sep 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/13151 FDA warns that Fentora should only be prescribed for approved conditions, and that dosage guidelines should be carefully followed.   Earlier this month, Fentora’s maker, Cephalon, Inc.,  sent letters to physicians containing many of the same warnings.

Fentora was approved only for treating pain in cancer patients.  It is intended for patients who experience breakthrough pain because they have developed tolerances to other opiate painkillers.   Fentora 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 Fentora is only approved for cancer patients, it is known that many doctors prescribe the drug “off-label” for headaches and back pain.  Once a drug has been approved by the FDA  doctors are free to prescribe it as they see fit.  The FDA said that several Fentora-related deaths have occurred in patients who were prescribed the drug for off-label use.  The FDA advisory warns that Fentora should not be used for any other conditions including migraines, post operative pain or pain due to injury.   It should also only be given to patients who have developed opiate tolerance, as others will not be able to handle the high amounts of fentanyl contained in Fentora.

The FDA says that other Fentora deaths have been due to doctors prescribing higher-than-recommended doses of the drug.  The FDA advisory says that Fentora contains much higher amounts of fentanyl than other opiate painkillers, including Actiq.  For that reason, Fentora is not a suitable substitute for these other painkillers.  And the FDA says that doctors must use care in determining the appropriate dose of Fentora for each patient.

Finally, the Public Health Advisory warns people taking Fentora and their caregivers to carefully follow the drug’s label directions.  The agency also advises that patients and caregivers become familiar with the signs of fentanyl overdose.   These include breathing problems or shallow breathing; tiredness, extreme sleepiness or sedation; inability to think, talk or walk normally; and feeling faint, dizzy or confused.  Fentora patients exhibiting these symptoms should be given immediate medical attention.

At least three separate investigations are underway to determine if Cephalon is marketing Fentora for off-label use. Off-label marketing of a drug is illegal, even though off -label use is not. An investigation being conducted by the Connecticut Attorney General’s office has already determined that Cephalon actively promoted off-label use of Fentora’s predecessor, Actiq.   The US attorney in Philadelphia and a congressional probe are also looking into Cephalon’s marketing of Fentora.  

]]> http://www.yourlawyer.com/topics/overview/fentora_overdose Wed, 26 Sep 2007 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/fentora_overdose Fentora Overdose Dangers Fentora, a popular narcotic painkiller manufactured by Cephalon, was implicated in the deaths of four people in September 2007.   The drug, which was approved by the Food & Drug Administration (FDA) in 2006, is only approved for use in cancer patients in severe pain.   Fentora contains fentanyl, a highly addictive opiate 80 times more powerful than morphine.  Fentanyl is considered a Class II substance by the Drug Enforcement Administration, putting it in the same class as cocaine or heroine. 

Fentora is a faster acting version of Cephalon’s Actiq, another narcotic painkiller.   Sold as a berry-flavored lozenge on a stick, Actiq has been linked to more than 120 deaths, including those of two children who thought the drug was candy.  Actiq will soon be available in a generic version, and Cephalon says that it will eventually seek approval for Fentora to be used to treat all acute pain that doesn’t respond to other opiate painkillers.

Unlike Actiq, Fentora is sold in a pill form.  For now, Fentora is approved only for use in cancer patients already taking morphine or other narcotic painkillers.  Fentora was meant to relieve brief periods of “break through pain” that occurred following the administration of these other narcotic painkillers.   According to the warning letter Cephalon sent to physicians following the four deaths related to Fentora, none of the fatalities occurred in cancer patients.   Two deaths occurred in patients prescribed Fentora for headaches, a third was the result of “improper dosing” and a fourth used the drug to commit suicide.

Fentora Off Label Use
Off label use occurs when a drug is used to treat a condition for which it was not approved.  It is known that physicians prescribe Fentora to treat headaches and back pain, even though it is only indicated for use in cancer patients.   Such off label use is not illegal.  However, a drug company is barred from marketing a medication based on its off label uses.

Cephalon has been in trouble before for marketing the off label uses of Actiq.   In 2006, an investigation conducted by the Wall Street Journal found that 80-percent of those being treated with Actiq were not cancer patients.  That same investigation found that Cephalon often marketed Actiq to sports medicine and family practice physicians, and not just cancer specialists.  A 2006 investigation by the Connecticut Attorney General found evidence that Cephalon had been marketing Actiq for off-label use, including setting high sales quotas for the drug that could only be reached if Actiq was prescribed off label.

Now, Cephalon is being investigated by Connecticut, as well as the US Attorney in Philadelphia and the US Congress for the off label marketing of Fentora.  Since it was approved, more than 80,000 prescriptions have been written for Fentora – a high number considering the limited uses for which it was approved.   Considering Cephalon’s history of off label marketing with Actiq, suspicions have been raised that the company is employing the same type of marketing with Fentora.


Legal Help for Fentora Overdose and Injuries
If you or a loved one has been injured by Fentora, you may have valuable legal rights.  Please fill out the form at the right for a free case review by a qualified attorney.]]>