FDA Blocks Wider Use of Fentora Due to Fentanyl Overdose Risk
September 17th, 2008 • Filed Under: News • One Comment
Cephalon, Inc., the manufacturer of Fentora, has been informed by the FDA that they will not be allowed to expand the uses of their prescription painkiller due to the potentially fatal risk of fentanyl overdose the medication could pose.
Fentora is an oral medication that contains the powerful narcotic fentanyl . It belongs to the opioid group of prescription painkillers, which also includes codeine and morphine.
Fentora was approved by the FDA in 2006, for the limited purpose of treating breakthrough pain experienced by cancer patients who are already tolerant of opioid painkillers. Cephalon has been seeking wider approved uses for breakthrough pain among those with chronic lower back and nerve pain.
The FDA has previously issued an alert to healthcare providers about potential Fentora side effects which could result in fentanyl overdose if it is prescribed off-label or abused, as the drug can be highly addictive.
In February 2008, Cephalon sent a letter doctors warning them to carefully follow Fentora dosing instructions and to prescribe the drug only to those who are already under a continuous opioid drug treatment.
The FDA has notified Cephalon that they will not approve the broader use of Fentora unless the drug maker can come up with a better way to inform users and the medical community about the fentanyl overdose risks.
An independent panel of experts convened by the FDA in May 2008, reviewed the potential for expanding the use of Fentora. The panel voted 17 to 3 against the wider use on the ground that greater availability of Fentora could increase the potential harm from abuse and overdose.
A number of deaths from fentanyl overdose have been associated with Fentora, as well as other powerful painkillers that contain fentanyl, such as the Actiq fentanyl lollipop and fentanyl pain patches.
Actiq Lollipop, which is another fentanyl drug manufactured by Cephalon, contains the painkiller in a lozenge on the end of a stick which the user sucks on. Actiq has been found to be widely prescribed off label for conditions like back pain and headaches, leading to a Congressional inquiry of Cephalon in March 2007.
Comment by chawn on 17 September 2008:
do something about the medication. have had severe nerve damage for several years. this is the only medication that has helped except for having to go the dr and get a shot of demerol which knocks you out. i can work and function on the drug. the cost has got to come down or insurance companies will no longer cover me./thanks