Four fatalities have been linked to the recently approved drug, Fentora, a powerful painkiller intended for cancer pain, according to Cephalon Inc., the drug manufacturer Thursday.
It appears all four deaths are the result of improper use of the drug, Fentora, manufacturer Cephalon Inc. said.
The drug was approved in September by the FDA for use by cancer patients. Fentora contains fentanyl, a drug similar to morphine, but much stronger and highly addictive. The FDA classifies Fentanyl as a Schedule II substance, which puts the drug in the same category as cocaine.
Cephalon said Fentora has been linked to a total of four deaths. The company said three of those, which appeared to result from respiratory failure, were related to inappropriate prescribing of Fentora. Two of the patients were prescribed the potent drug for headaches even though they weren’t on round-the-clock opiate therapy, the company said. The company said it also received a report of a fourth death, a person who committed suicide while taking the drug but wasn’t prescribed the drug by a doctor.
Doctors are permitted to prescribe drugs as they deem fit, including off-label use. However, off-label marketing by the drug manufacturer is illegal.
The FDA is closely monitoring the issue and working with the company to assure the safest use of Fentora. At this time the FDA has not addressed who is at fault for the deaths.