The pain medication Fentora has been linked to serious adverse events, including at least four deaths.
The drug was approved for use in September 2006 for cancer patients who had built up a tolerance for morphine or other prescription narcotics used to treat their pain. Since then, 78,000 prescriptions have been written for Fentora, which contains the potent painkiller fentanyl.
The U.S. Food and Drug Administration said it was looking into the safety of Fentora since its manufacturer, Cephalon Inc., sent a letter to doctors on Sept. 13, 2007 warning of serious adverse events, including deaths most likely due to respiratory failure.
If you or a loved one suffered a serious adverse side effect or death after using Fentora, you may want to contact a Fentora attorney.
Cephalon said it believed adverse events may have been caused by improper use of the drug. Some doctors have prescribed Fentora for off-label uses, including to treat headaches. Two of the reported deaths were believed to have occurred in headache patients.
Cephalon has been the focus of three separate investigations over allegations that it promoted Fentora and another drug, Actiq, for uses other than those outlined in the medications' FDA-approved labels. Cephalon denied the allegations but said it was cooperating with investigations by Congress, the Philadelphia U.S. Attorney's Office and the Connecticut Attorney Generals Office.
A probe by Connecticut Attorney General Richard Blumenthal found that the company promoted Actiq off-label to neurologists to treat headaches and promoted larger prescriptions at higher doses, according to an article in The Wall Street Journal which quoted sources familiar with the investigation.
It is not illegal for doctors to prescribe drugs for off-label use, but drug companies are barred from marketing them for purposes other than those approved by the FDA.
Kline & Specter, PC, a firm based in Philadelphia with some 30 attorneys, several of whom are also highly skilled doctors, has had success litigating product liability and prescription drug lawsuits in Pennsylvania, New Jersey and nationwide. Contact a Fentora lawyer today.
- Cephalon Drug Is Tied to Several Deaths (Full story)