The FDA has issued a warning notice for off-label use of Fentora after three deaths were linked to off-label usage of the fentanyl tablet.
One issue may be related to the substitution of Fentora for another powerful pain medication, Actiq. Both are manufactured by Cephalon, but Fentora is absorbed more quickly than is Actiq. Therefore, the same dosage of Fentora may result in more of the drug being absorbed into the bloodstream.
Cephalon has been plagued by accusations of aggressive detailing, including encouraging physicians to prescribe the drug off-label. Another recent article indicates the pharma industry has been aggressively lobbying the FDA to allow this type of detailing, which evidently has been going on for two years despite restrictions against the practice.
Of note to workers compensation insurers, Fentora appears to be becoming increasingly popular for treatment of back pain in some areas.
What does this mean to you?
If you are a WC payer, find out which claimants are taking Fentora and figure out why and if it is appropriate. Not only is the drug dangerous, it is also very expensive.
Jan
23
This news is way back from September 27, 2007. Although not to timely, it is still very important.
Fentora has studies supporting its use in the treatment of low back pain, whereas Actiq did not. It would not be surprising if Cephalon petitions for the low back pain indication (with certain restrictions) before too long.
I’m still waiting to see what, if anything, comes out of Waxman’s Committee on Oversight and Government Reform subpoena of Cephalon back on March 1, 2007 regarding the inappropriate marketing of Actiq and Fentora.
My guess: Cephalon pays a speeding ticket of a few hundred million, and the potentially inappropriate use continues.
the company has or is about to try to get this drug for back pain.
i take 400mcg 3 tabs/day for breakthrough pain,and its not nearly enough,i keep telling them when they stop at an arbitrary amount,to TITRATE me to the dose,dnt pick a dose and refuse to titrate higher for no medical reason.
my long term med is 2 200mcg patch/2 days.that is firly new but seems perfect.