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Fentora Linked to Four Deaths, As Cephalon Faces Scrutiny Over Off-Label Marketing

Sep 14, 2007 | Parker Waichman LLP, LLP

Fentora, a powerful narcotic pain killer and the subject of three separate investigations for off-label marketing, has been linked to four deaths.  Those incidents have prompted the drug’s maker, Cephalon Inc., to send warning letters to physicians about the deaths, which the company says were the result of improper use, and not because of any drug side effects.

Fentora and a related medication, Actiq, were approved by the Food and Drug Administration (FDA) only for use in cancer patients.   Both contain 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 and Actiq are only approved for cancer patients, it is known that many doctors prescribe the drugs “off-label” for headaches and back pain.  Once a drug has been approved by the FDA, however, doctors are free to prescribe it as they see fit.  However, drug companies are prohibited from advertising a drug’s off-label uses.

Now, Fentora has been implicated in the deaths of four people.  According to the letter Cephalon sent to physicians, some of those deaths were related to off label use.   Cephalon says that two of the patients who died were taking Fentora for headaches.  A third death was the result of a patient using the drug to commit suicide, but who hadn’t been prescribed Fentora by a doctor.

Fentora is a fast acting version of Actiq, an earlier pain reliever sold by Cephalon.  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.  An investigation by the Wall Street Journal in November found that 80-percent of patients taking Actiq did not have cancer.  It appears that many patients are also being prescribed Fentora for ailments that it is not approved to treat.

Now, three separate investigations are underway to determine if Cephalon is marketing Fentora for off-label use.  An investigation being conducted by the Connecticut Attorney General’s office has already determined that Cephalon actively promoted off-label use of Actiq.   The  US attorney in Philadelphia and a congressional probe are also looking into Cephalon’s marketing of Fentora.  The Wall Street Journal is reporting that a person familiar with the matter said Cephalon is "in active discussions" about a possible settlement with the Connecticut attorney general and the U.S. attorney in Philadelphia. According to the Journal, any such settlement would involve a large fine and require that Cephalon take remedial measures to reform its aggressive marketing practices.


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