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The powerful narcotic Fentora, used to treat acute pain in cancer patients, has been linked to four deaths. Since its launch last October, approximately 78,000 prescriptions have been written for the drug.
According to drug maker Cephalon Inc., three of the four deaths seemed to be due to respiratory failure and may have been caused by inappropriate prescribing. Two of the deaths were in patients who had been prescribed the drug for headache pain.
The fourth death occurred in a person who did not have a prescription for the drug and committed suicide, the company said.
A Potent Narcotic
Fentora contains fentanyl, a narcotic 80 times more potent than morphine. The Drug Enforcement agency classifies fentanyl as a Schedule II substance, which means the drug is highly addictive and associated with a risk of deadly overdose.
Off-Label Prescribing
Like its predecessor Actiq, Fentora is only approved by the Food and Drug Administration for use in patients with cancer. Doctors, however, frequently prescribe the drugs for back pain and headaches.
Prescribing drugs for “off-label,” or unapproved, uses is not illegal. However, it is illegal for drug makers to market their drugs for such uses.
Cephalon's Marketing Practices Scrutinized
Cephalon is currently under three separate investigations over its marketing practices, though the company denies promoting the Fentora and Actiq for uses other than indicated by the FDA.
“We have been monitoring this issue. The FDA takes this very seriously, and we are working with the company to assure the safest possible use of this medication,” said Susan Cruzan, FDA spokeswoman.
(Source: The Wall Street Journal online)
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