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Fentora

Fentora Side Effects May Lead To Overdose Lawsuits

Fentora | Lawsuits, Lawyers | Side Effects: Overdose, Improper Dosing, Fatalities

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 and 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 does not 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 or call us at 1-800-YOURLAWYER (1-800-968-7529).



 

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FDA, CDC Probing Painkiller Overdoses/020209/Cynthia Diaz

Feb 9, 2009
Two federal agencies are collaborating on the issue of opioid use and related accidental, often fatal, overdoses.  AMedNews reported that the agencies are hoping to find a way to ensure the painkillers are both save and available. "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...

Report Says US Fentanyl Deaths Exceed 1,000 in Two Years, but Report Incomplete

Jul 25, 2008 | Parker Waichman LLP
The Associated Press (AP) reports that over 1,000 people died in a two-year period due to an illegal version of the painkiller Fentanyl.  The information was derived from a government report providing the first national figures on the Fentanyl deaths.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...

Expanded Fentora Approval a Bad Idea, FDA Panel Says

May 7, 2008 | Parker Waichman LLP
Cephalon Inc's quest to expand the approved uses of the narcotic painkiller 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...

Expanded Fentora Approval a Bad Idea, FDA Panel Says

May 7, 2008 | Parker Waichman LLP
Cephalon Inc's quest to expand the approved uses of the narcotic painkiller 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...

FDA Concerned Expanded Fentora Approval Could Increase Abuse

May 5, 2008 | Parker Waichman LLP
The US Food and Drug Administration (FDA) has long been concerned over Cephalon Inc.’s marketing of 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...

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