Painkiller kills four in Washington

Use of FDA approved drug Fentora has resulted in the death of four patients in Washington, USA. The drug had been prescribed as a painkiller for headaches.

According to the Pennsylvania based drug manufacturer Cephalon Inc., a biopharmaceutical company founded in 1987, the fatalities occurred due to improper usage of the drug. The company states that incorrect dosages resulted in these deaths.

There have been allegations on the company 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. The company denies these allegations.

Fentora was granted approval by the FDA in September 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.

Amongst the four death cases in question, two only involved headaches. While one was a case of suicide, the last one was a case of over-prescription. Thus, none of the cases were qualified as candidates for the use of Fentora.

According to Cephalon spokesperson Candice Steele, “None of the reports were in cancer patients, which lead us to believe they were inappropriate candidates for the product.”

Fentanyl is an opioid analgesic with a potency that is eighty times that of morphine. In the past, it has been used as an intravenous anesthetic under the trade name of Sublimaze. Fentanyl lozenges are meant for opioid tolerant individuals and are very useful for treatment of breakthrough cancer pain.

The biological effects of the fentanyls 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. Because the effects of fentanyl last for only a very short time, it is even more addictive than heroin, and regular users may become addicted very quickly. Additionally, fentanyl may be hundreds of times more potent than street heroin, and tends to produce significantly worse respiratory depression, making it somewhat more dangerous than heroin to users

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.

Actiq, also manufactured by Cephalon, is a Fentanyl containing drug meant for treating breakthrough cancer pain, pain for those suffering from bone injuries, migraines, severe back-pain, neuropathy, arthritis, and other situations of moderate to severe chronic, non-malignant pain.

"The FDA takes this very seriously, and is working with the company to assure the safest possible use of this medication," Steele stated.

The company states that it is currently testing the drug for other types of pain. Cephalon is also expecting to seek FDA approval for expanding the approved uses for the drug by the end of this year.