FDA Warning

PAINKILLER PATCHES CAN KILL IF DOSE IS TOO HIGH

The government announced Friday that it was investigating 120 deaths
among users of patches that emit the painkiller fentanyl and warned
patients to be sure to use the drug properly to avoid accidental overdose.

Among the warnings in patient information sheets issued Friday:

Fentanyl patches can cause trouble breathing, which can be fatal. Get
emergency help if you have trouble breathing or extreme drowsiness
with slowed breathing; feel faint, dizzy, confused; or have other
unusual symptoms. They can be signs you have received too high a dose.

Fentanyl patches are only for round-the-clock pain that is moderate
to severe and expected to last for weeks.

The patches should not be your first narcotic painkiller; they're
only for people whose bodies are used to morphine or related
painkillers known as opioids.

Do not use fentanyl patches if you have sudden or severe asthma, or a
gastrointestinal problem called paralytic ileus.

Store patches out of reach of children and dispose of them by
sticking the adhesive sides together and flushing down the toilet,
not in trash cans where children can find them.

Abuse of fentanyl patches is a recurring problem because they contain
such a high concentration of the controlled substance. But a
spokesman for the FDA said the current concern stems from legitimate
patient use.

"The directions ... must be followed exactly to prevent death or
other severe side effects from overdosing," the FDA warned in letters
to doctors that also advise prescribing the lowest possible dose.

The patches were first approved under the brand name Duragesic in
1990, and a generic version hit the market in February.

FDA has reports of death among users of both, the FDA spokesman said.

On The Web: www.fda.gov/cder/drug/infopage/fentanyl/default.htm