Litigation

Lollipop, Lollipop, Doctor, I've Got a Major Headache

By Angel Reyes

Update on Actiq and Fentora: Opioid Narcotics Prescribed Off-Label for Headache Pain?
 
Over the past few years I've written extensively about fentanyl pain patches such as the Duragesic patches sold by Sandoz, Alza Pharmaceutica and Johnson & Johnson.  Fentanyl pain patches are also sold by Mylan, Watson and Actavis.  Currently hundreds of wrongful death lawsuits are pending against this collection of fentanyl pain patch manufacturers.  At least four cases have gone to trial against J&J, Sandoz, and Alza, all of which resulted in the plaintiff recovering money for damages, in these cases wrongful death, caused by the fentanyl pain patches.

Now comes an update to an earlier post about Actiq and Fentora, two lollipops that pack a powerful fentanyl punch.  Indeed, hundreds of people have died due to respiratory failure caused by the active ingredient in Actiq and Fentora, fentanyl.  Actiq and Fentora were approved by the FDA only for use by opiod tolerant patients.  Cephalon brought its supercharged marketing to Actiq back in 2000.  Since that time, sales, which were in the tens of millions before Cephalon got involved, surged into the hundreds of millions by 2006.  This didn't happen by accident, according to Prime Therapeutics, Actiq was being prescribed 'off-label' 90% of the time.  That means that doctors were listening to Cephalon's bonus driven sales force and prescribing the drug to people who complained of headache pain!  Who cares about the important warning that the drug only be prescribed to opioid tolerant patients?  Thankfully, the FDA did.  Cephalon has since pled guilty to a criminal charge for Distribution of Misbranded Drugs and paid a fine of $425 million.

Did that stop Cephalon?  Heck no, as soon as Actiq became open to generics, Cephalon bought Fentora, a new opiod drug manufactured by Cima Labs.  Cephalon super charged Fentora's marketing in the fall of 2006.  Soon sales were zooming and so was 'off-label' prescriptions.  Sound familiar?  It should, that's exactly what Cephalon did with Actiq!  The lesson here is this; before you take any prescription with fentanyl in it, be darn sure that you are opiod tolerant, because your doctor may not.

Full post as published by Angel Reyes Blog on January 05, 2010 (boomark / email).