U.S. WARNS OF DANGERS FROM PATCH USED FOR PAIN

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.