Cephalon, the makers of the powerful painkiller Fentora issued letters last week reinforcing prescription and dosage information. The so-called “Dear Doctor” letters were sent out in response to the news that four deaths had been linked to the extremely powerful painkilling lozenge. Cephalon could be in store for further labeling revisions in the near future if more cases of this sort are reported. Fentora is designed to treat acute breakthrough pain (pain that still “breaks through” other pain killers) in cancer patients. The intended recipients are to be patients that are tolerant of opioids and still have persistent pain when already on round the clock opioid therapy. Three of the patients that died were taking it for headaches.
Doctors have the right to prescribe medication for off-label uses as they see fit and this seems to be what occurred in these instances. It is speculated that some physicians that prescribed the drug for headaches thought it was a new form of an older Cephalon made drug Actiq, a flavored lollipop painkiller. This is however not the case. Fentora is substantially stronger than Actiq and has a much higher chance of causing serious adverse reaction in those not previously tolerant of opioids.
In light of the deaths, which occurred this summer, Cephalon and US regulators are re-evaluating the existing risk management program for Fentora as well as labelling, company spokesperson Stacey Beckhardt said. “We are looking at all aspects of the Fentora program,” she said, adding that, “Labeling revisions are on the table.”
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