More illegal off-label marketing? Fentora now under investigation

The drug Fentora is Cephalon’s next generation narcotic painkiller which is only approved for cancer patients who are in severe pain and already taking morphine or other painkillers. In other words, this drug should only be used for those cancer patients whose normal pain medications are not providing pain relief. This highly addictive drug is considered a “Class II” opiate, 80 times more powerful than morphine. So why are thousands of patients taking this drug for migraines, back pain and other injuries?

In 2007, after sales data revealed more than 80,000 prescriptions for Fentora, questions arose as to whether Cephalon was illegally marketing Fentora for off-label uses, after it had already been investigated in 2006 for illegally marketing its predecessor drug, Actiq.

Drug companies are not allowed to market the drugs for any reason other than what the Food and Drug Administration has approved. In 2008, an FDA panel denied Cephalon’s request to expand the approved uses of Fentora. One FDA official was concerned that use of Fentora in non-cancer patients could have devastating effects. Of particular concern is the risk of severe injury or death when Fentora is given to an individual who has never been exposed to this type of medication. Obviously, when Fentora or Actiq are prescribed for conditions other than cancer, the risk of opioid intolerance is greatly increased. In fact, Actiq has been linked to 127 deaths and 91 serious injuries from fatal respiratory complications.

In September 2007, following several deaths from Fentora, Cephalon issued a warning letter to physicians advising of serious adverse events and death involving Fentora. This warning, however, has apparently not been enough to stop physicians from prescribing this drug to non-cancer patients. Currently, Cephalon is being investigated for off-label marketing of Fentora.

Off-label marketing of drugs to physicians is illegal and should not be tolerated under any circumstances. This does not mean that physicians shouldn’t be allowed to prescribe drugs for uses that are not approved by the FDA. What it does mean, though, is that drug companies, particularly those who are aware that their drugs are being prescribed in this manner, need to conduct proper studies to confirm whether these off-label uses are safe and effective.

If you have been injured by Fentora or have first-hand knowledge of these off-label marketing practices, please contact us. Until these illegal practices stop, more lives will be needlessly lost to drugs like Fentora, which can help many people – but only if used properly.