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Healthline Connects
Healthline Connects

Important Safety Information for Fentora (Fentanyl buccal tablet)

On September 10th 2007, Cephalon, Inc., the manufacturer of Fentora (Fentanyl buccal tablet) issued both a Dear Doctor and a Dear Healthcare Professional letter in response to the deaths of some people who were using the drug.

Fentora (fentanyl) is a narcotic (opioid) medication indicated for the treatment of breakthrough pain in cancer patients who are already taking and are tolerant to opioid therapy for their cancer pain. The medication is not approved for use in patients who are not tolerant to opioids nor is it approved for use in treating patients with other types of pain including acute pain, post-operative pain, headache, migraine, or sports injuries.

And therein lies the problem. Of the four reported deaths due to Fentora (fentanyl), three were related to inappropriate prescribing of the drug, says the manufacturer. Two patients were prescribed the drug for the treatment of headaches, even though, contrary to the dosing guidelines, they were not on any other opiates. According to Cephalon, a fourth death was reported in an individual who was taking the drug though it had not been prescribed to the person; the individual eventually committed suicide.

Cephalon is now under the FDA's microscope but they have also managed to attract attention due to possible inappropriate marketing practices. According to the Wall Street Journal, the Connecticut Attorney General's investigation, which has been ongoing since 2004, found that Cephalon promoted Actiq (fentanyl citrate, oral transmucosal) to neurologists for the treatment of headaches which is an off-label use, amongst other questionable practices.

Bottom line: if you're a health professional then familiarize yourself with the proper use of Fentora(fentanyl) and key safety information regarding the drug. If you are a patient, arm yourself with appropriate questions for your healthcare provider and be an active participant in your treatment plan.
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