Friday, September 14, 2007

painkiller implicated in headache patient deaths


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A painkiller called Fentora is being blamed for four deaths, two of them headache patients. The headline of this article is slightly misleading because it seems to imply the patients were improperly using the drug. However, it seems their doctors were wrong to prescribe it to them in the first place.

Deaths Blamed on Improper Painkiller Use
The deaths of two patients prescribed a powerful painkiller as a headache treatment were among four fatalities linked to the recently approved drug, its manufacturer reported Thursday.

All four deaths apparently involved improper use of the drug, called Fentora, manufacturer Cephalon Inc. said. The Food and Drug Administration was monitoring the situation, a spokeswoman said.

The FDA approved the drug in September for use only by cancer patients already taking morphine or other prescription narcotics for their pain. Fentora contains fentanyl, which is similar to morphine, but far more potent.

Besides the two headache patients, the other deaths involved a suicide and a patient administered the drug outside the recommended dosing.

"None of the reports were in cancer patients, which leads us to believe they were inappropriate candidates for the product," Cephalon spokeswoman Candace Steele said.

Cephalon reminded doctors and pharmacists, in letters dated Monday but released Thursday by the FDA, of who should take the drug, and in what quantities and how often. The company also warned not to substitute Fentora on a one-for-one basis for another, older fentanyl drug called Actiq that it also makes, because the newer drug is stronger.

FDA's MedWatch has released an advisory on the topic:
Fentora (fentanyl buccal tablet)

As always, if you have been prescribed this medication and have concerns based on what you have read, please contact your doctor and discuss your options.

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