FDA feared expanding use of Fentora could lead to misuse, abuse

posted on:
March 26, 2010



Two years ago, the Food and Drug Administration (FDA) considered expanding the approved usage for Cephalon Inc.’s powerful painkiller Fentora to go beyond its limited use in the treatment of opioid-tolerant cancer patients. Originally approved by FDA in 2006, Fentora grew to enjoy a sizeable off-label usage for the treatment of back pain, injuries and headaches, and Cephlon sought to have this off-label use approved by the FDA. But the request was marked by at least five reported deaths from the unapproved use of Fentora.

The FDA was cautious in this request. “Fentora has attributes that make it particularly attractive to abusers” and could “lead to widespread abuse,” the agency stated on its Web site. In its review, the agency said granting the expanded usage could encourage “abuse and misuse, and increase the incidence of accidental exposures which … could potentially have devastating effects.”

Cephalon countered with a statement arguing that there is “no evidence that Fentora poses risks of abuse and diversion greater than other opioids” and that it sought to expand the drug’s indication to share important prescribing information with doctors, pharmacists and patients who were already using the drug for its off-label use.

Fentora is an opioid, a class of drugs that includes morphine. These narcotics decrease a patient’s perception of and reaction to pain as well as increase one’s tolerance to pain. Opioids are primarily misued because of their euphoric effects. 

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