The US government is investigating 120 deaths among users of patches that emit the painkiller fentanyl and warned patients Friday to be sure to use the powerful narcotic properly to avoid accidental overdose.
The Food and Drug Administration (FDA) is probing whether any of the deaths are related to inappropriate use of the painkiller or factors related to the product's quality.
At least some may have been accidental overdoses, and reports suggest patients or prescribers weren't aware of crucial safety information on the drug's label, said FDA's Dr. Robert Meyer. That prompted Friday's unusual public health advisory.
The patches, containing the narcotic fentanyl, are marketed under the name Duragesic by Janssen, a company owned by Johnson & Johnson. A generic version was put on the market in February by Mylan Laboratories. Duragesic had sales of more than $2 billion in 2004.
The patches are intended for people with moderate to severe chronic pain that requires treatment around the clock for an extended period of time and that cannot be controlled by other narcotics alone, the F.D.A. and the manufacturer say. Only those already tolerant of narcotics, as some cancer patients are, should use the patches. People recovering from surgery, or suffering from short-term pain for other reasons, should not.
Abuse of fentanyl patches is a recurring problem because they contain such a high concentration of the controlled substance. But Meyer said the current concern stems from legitimate patient use.
In June, Janssen sent a warning letter to doctors stating that deaths and other serious medical problems had occurred in people who were accidentally exposed to Duragesic by sitting on a patch or touching it while putting it on someone else. In addition, a patch accidentally stuck to a child who was hugged by an adult who had been wearing it; the company did not say whether the child survived.
Fentanyl in any form is also popular with drug abusers, and a report issued this month by the National Center on Addiction and Substance Abuse said the patches were increasingly implicated in cases of abuse, and were often stolen from hospitals and clinics and then cut open to extract the fentanyl.
A spokesman for Johnson & Johnson said the patches, when used properly, were an important treatment. Mylan declined to comment on the public health advisory.
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