Pubdate: Sat, 16 Jul 2005
Source: New York Times (NY)
Section: Health in the News
Copyright: 2005 The New York Times Company
Author: Denise Grady
Bookmark: (Chronic 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.
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