WASHINGTON - Improper use of patches that emit the painkiller fentanyl is
still killing people, the U.S. government said Friday - its second warning in
two years about the powerful narcotic.
Some of the deaths came after doctors prescribed the patches to the wrong
patients, the Food and Drug Administration said.
The drug is only for chronic pain in people used to narcotics, such as cancer
patients, and can cause trouble breathing in people new to this family of "opioid"
painkillers. Yet the FDA found cases in which doctors prescribed the patch for
headaches or post-surgical pain.
The FDA said patients also accidentally overdose by using the patches
incorrectly, such as putting on more than prescribed, replacing them too
frequently or getting them too hot.
"While these products fill an important need, improper use and misuse can be
life threatening," said FDA pain chief Dr. Bob Rappaport. "It is crucial that
doctors prescribe these products appropriately and that patients use them
correctly."
The FDA first warned about improper patch use in 2005, when it announced it was
investigating 120 deaths.
Although the agency has investigated the new reports for several months,
Rappaport refused to say Friday how many additional deaths the agency has
learned of since that first warning.
He called the number of reports small but concerning because "they are
preventable." The FDA said Friday it had ordered patch makers to create special
medication guides that will come with every box, spelling out proper use in
easy-to-understand language.
What kind of mistakes are happening? The Institute for Safe Medication
Practices, a consumer advocacy organization, highlighted some cases last summer.
One patient died after being given a patch for post-surgery pain despite having
pneumonia and being new to narcotics. Two others survived - an elderly man taken
to the emergency room after being given a patch together with painkilling pills
and an elderly woman who became delirious while wearing several patches at once.
Fentanyl patches have been marketed in Canada since 1992 for severe chronic
pain. When used appropriately and as recommended, the benefits of fentanyl
patches outweigh the risks, Health Canada said in an e-mail statement Friday.
"Health Canada is aware of today's action by the U.S. Food and Drug
Administration. The department will review the Canadian Product Monographs to
determine if further revisions are necessary. At this time, we have no plans to
create a medication guide on fentanyl."
The FDA's main message Friday: Do not prescribe fentanyl patches to anyone new
to opioids, the painkiller family that includes morphine. Absorbing fentanyl
through the skin is a powerful way to deliver the potent drug and thus poses
serious risk to anyone not already opioid-tolerant, Rappaport explained.
Doctors who aren't specially trained in pain management may not know that. But
Rappaport said the FDA isn't considering curbs on prescribing because there is a
great need for the patches among the millions of chronic pain sufferers, few of
whom get care from pain specialists.
Among the warnings:
-Fentanyl patches can cause severe breathing problems. Get emergency help if:
you have trouble breathing or extreme drowsiness with slowed breathing; feel
faint, dizzy or confused; or have other unusual symptoms. They can be signs that
you were prescribed too high a dose or took too much.
-Fentanyl patches are only for round-the-clock pain that is moderate to severe
and expected to last for weeks. They are not for sudden, occasional or mild
pain, or pain after surgery.
-The patches should not be your first narcotic painkiller.
-Ask your doctor how often to apply the patch, whether to reapply one that has
fallen off and how to replace it. Doing any of that incorrectly can cause an
accidental overdose.
-Do not use heating pads, electric blankets, saunas or heated waterbeds, take
very hot baths or sunbathe while wearing a fentanyl patch. Heat may increase the
drug's absorption, causing a life-threatening overdose. Call a doctor right away
if body temperature rises above 39 C. while wearing a patch.
The patches were first approved under the brand name Duragesic in 1990, but
generic versions are now sold by other manufacturers.
Source : Reuters 2007
