Drug company warned doctors of off-label use of Fentora after deaths

posted on:
April 8, 2010

author:
JENNIFER WALKER-JOURNEY

In 2007, drug maker Cephalon sent a letter to pain management specialists reminding them that its potent painkiller Fentora should only be used to manage breakthrough pain in cancer patients who are already taking and are known to be tolerant to opioids, painkillers in the same class as morphine. Cephalon informed these health care professionals that some patients had died while using Fentora and some serious adverse events occurred because of what the company called “improper patient selection (e.g. use in opioid non-tolerant patients), improper dosing, and/or improper product substitution.” Reports revealed that two deaths occurred in patients given Fentora to treat headaches. A third person died because he took the wrong dose, and a fourth patient took the drug to commit suicide.

The Food and Drug Administration (FDA) never approved use of Fentora beyond the treatment of breakthrough pain in opioid-tolerant cancer patients. Yet, it was revealed that Cephalon actively paid doctors to inform other health care professionals of the off-label use of Fentora to treat everything from headaches, backaches and injuries. While off-label prescribing by doctors is not illegal, off-label marketing is. And the results were fatal.

Fentora contains the active ingredient fentanyl, a controlled substance with a high potential for abuse and overdose, which leads to respiratory depression and death. In its letter to health care professionals, Cephalon informed physicians that they should be aware of the potential for misuse when prescribing any drug, and in the case of Fentora and other opioids, to be extra careful because of the high potential for misuse, abuse, or diversion of these substances.

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