FDA issues warning about painkiller Fentora's fatal side effects

The U.S. Food and Drug Administration on Wednesday cautioned patients and doctors about the improper and potentially fatal misuse of a pain drug for cancer patients, called Fentora. An overdose of this strong painkiller can prove fatal, the health agency warned.

Made by Cephalon Inc., Fentora tablets can be recommended to those cancer patients who experience breakthrough pain and who are already taking opioids, a form of narcotic, on a frequent basis.

The health agency said this powerful painkiller should not be used to treat short-term pain such as migraines and should not be used by patients who have not developed tolerances to other opiate painkillers.

The US health watchdog warned that using Fentora outside of approved guidelines could result in deadly overdoses. Fentora should be used only by patients who take opioids regularly and have developed a tolerance to narcotic pain medicines.

Fentora that resulted in the death of four patients earlier this month in Washington contains fentanyl, an opioid agonist and a Schedule II controlled substance, which has the highest potential for abuse and risk of fatal overdose due to respiratory depression.

According to Cephalon, Schedule II opioid substances include morphine, oxycodone, hydromorphone, oxymorphone and methadone.

FDA’s warning comes after it received reports of several deaths related to the drug. FDA said it has approved Fentora for treating breakthrough pain in cancer patients who are opioid-tolerant, but many doctors are prescribing the drug "off-label" for headaches and back pain.

Several Fentora-related deaths have occurred in patients who were prescribed the drug for off-label use, the agency said. It warned the drug should be used only to treat intense bouts of very severe pain, and should not be given to non-opioid patients, as they will not be able to handle the high amounts of fentanyl contained in Fentora.

"FDA is monitoring this issue very closely," said Steven Galson, director of the FDA's Center for Drug Evaluation and Research. "We are working with the manufacturer to ensure the safest use of this medicine. Health-care professionals and patients need to be aware of the potential for fatal overdose with the improper use of Fentora."

The alert also comes more than two weeks after Cephalon warned doctors and health-care professionals about several patient deaths related to inappropriate prescribing of the drug. In a letter, dated September 10, sent from Cephalon to health care professionals, it has been stated and clarified that Fentora is not a substitute for Actiq as Fentora is much stronger. The letter also states that the drug should not be used for treatment of post-operative pain, acute migraine, and bone injuries.

Of the four death cases in question, three people died from using the drug outside of recommended guidelines, while one was a case of suicide. None of the three patients who died due to over-prescription had cancer. Of these three patients, two had migraines and were not taking opioids on a daily basis, while the third one was taking another opioid.

There have been allegations on the Pennsylvania based drug manufacturer Cephalon that it was reportedly engaged in fallacious promotion and marketing of Fentora for uses which have not been approved by the FDA and which are not specified on the labels. However, the company denied these allegations.

Founded in 1987, the biopharmaceutical company said it is working with the FDA to strengthen warnings and improve the dosing instructions in Fentora's product labeling. The health regulators also asked the company to improve its education plan to make patients and physicians more aware about the proper use of the drug.

Fentora was granted approval by the FDA in September last for usage only by cancer patients who are already undergoing treatments involving morphine or other prescription narcotics. Fentanyl, an ingredient of Fentora, is responsible for reducing acute pain in cancer patients.

The biological effects of the Fentanyl are similar to those of heroin, with the exception that there is less of a euphoric 'high' associated with the drug and a stronger sedative and analgesic effect.