FDA INVESTIGATES 120 DEATHS POSSIBLY TIED TO USE OF PAIN PATCH

WASHINGTON -- The Food and Drug Administration said Friday that it
was investigating 120 reports of deaths possibly linked to overdoses
from fentanyl narcotic pain patches.

"The agency has been examining the circumstances of product use to
determine if the reported adverse events may be related to
inappropriate use of the patch or factors related to the quality of
the product," the FDA said in a statement.

The patches are attached to patients' skin to deliver the medication
fentanyl, a powerful narcotic designed to treat chronic pain. They
are sold under the brand name Duragesic by a unit of Johnson &
Johnson and have been available as a generic since earlier this year.
Fentanyl is in a class of drugs known as opioids, which are used to treat pain.

"Patient safety is our first priority," said Kellie McLaughlin, a J&J
spokeswoman. "We've been consistently communicating safe use of Duragesic."

The FDA also issued a public-health advisory telling patients and
health-care professionals how to properly use and dispose of the pain patches.

Last month, J&J updated Duragesic's label to include new warnings
about proper use of the medication and the potential for interaction
with alcohol and a variety of other prescription drugs. In a letter
to health-care professionals, J&J said that the changes reflected "a
heightened awareness of safety issues associated with opioids in
general, such as misuse, abuse and diversion."

Last week, the FDA asked Purdue Pharma LP to remove its painkiller
Palladone over concerns that small amounts of alcohol may cause fatal
reactions with the drug.

In its alert to health-care professionals Friday, the FDA said it
recently conducted a review of adverse-event reports for Duragesic.
The FDA said sorting out unintentional overdoses was difficult
because many patients had underlying diseases such as cancer that
could have contributed to their deaths.

In other cases, the agency said, more than one patch was used and
sometimes in combination with other drugs. Some patients reportedly
injected or ingested the contents of the patch and added a heat
source, which possibly can increase the amount of fentanyl absorbed
into the skin. The FDA said there were also reports of leaking patches.

The FDA said fentanyl patches should be used only in patients who
have successfully used opioids in the past and shouldn't be a
patient's first experience with an opioid. The patch is intended for
long-term pain management and shouldn't be used for short-term pain
such as that after surgery or an injury.