• 7/16/2005
  • Washington, DC
  • Denise Grady
  • New York Times

The government warned yesterday that painkilling skin patches could cause drug overdoses and said it was investigating reports of serious side effects and 120 deaths that might have resulted.

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.

A spokeswoman for the Food and Drug Administration said the 120 deaths had occurred since Duragesic was first approved in 1990 and added that the investigation was still going on and that it was not known whether the product actually caused the deaths and other problems reported in users.

Describing fentanyl as a “very strong narcotic,” the F.D.A. issued a public health advisory stating that some patients and doctors might not be fully aware of its dangers. An overdose can cause a person to stop breathing; taking off the patch will not reverse the effects because the drug has already built up in the person’s system and may continue to be absorbed from the skin for 17 hours or more.

The advisory warns that the patches must be used exactly as prescribed and that doctors and patients must be alert for signs of overdose like breathing difficulties, extreme tiredness and feelings of faintness or dizziness.

The advisory notes that people wearing the patches may suffer overdoses or other serious side effects if they drink alcohol, have an increase in body temperature or are exposed to heat from sources like heating pads, electric blankets, heat lamps, saunas, hot tubs or heated water beds. Certain medicines, including antifungals and some drugs used to treat H.I.V., can also lead to fentanyl overdoses in people wearing the patches.

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.