Second Safety Warning on Fentanyl Skin Patch
From The
Food & Drug Administration
Date Posted: December 21, 2007
FDA issued its second safety warning on Dec. 21, 2007,
about the fentanyl transdermal
system, an adhesive patch that delivers a
potent pain medicine through the skin. In July 2005, FDA issued a similar
warning to the public and to health care providers emphasizing that the directions
on the product label and on the patient package insert should be followed
exactly in order to avoid overdose.
FDA has continued to receive reports of
deaths and life-threatening side effects after doctors have inappropriately
prescribed the patch or after people incorrectly used it.
The agency is also
asking manufacturers of all fentanyl
patches to update their product information
and to develop a medication guide for patients. The patch is marketed as
Duragesic by Johnson and Johnson, and generic versions are sold by other
manufacturers.
The fentanyl skin patch contains the opioid fentanyl, a potent
narcotic. The patch was approved by FDA in 1990 for use in people with persistent,
moderate-to-severe pain who have become opioid-tolerant – meaning that they
have been using another strong opioid narcotic pain medicine around-the-clock
for a week or longer. The skin patch is most commonly prescribed for people
with cancer.
Recent
reports to FDA describe deaths and life-threatening side effects after health
care professionals inappropriately prescribed the patch or after people used
the patch incorrectly.
Advice for Consumers:
•
Fentanyl patches are only for people who are opioid-tolerant
and have chronic pain that is not well controlled with other pain medicines.
The patches are not to be used to treat sudden, occasional, or mild pain,
or pain after surgery.
•
Be aware of the signs of fentanyl overdose: trouble
breathing, or slow or shallow breathing; slow heartbeat; severe sleepiness;
cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or
confused. If these signs occur, get medical attention right away.
•
If you
are prescribed the fentanyl patch, tell your doctor, pharmacist, and other
health care professionals about all the medicines you take. Some medicines
may interact with fentanyl, causing dangerously high fentanyl levels in the
blood.
•
Read the instructions on how to use the fentanyl patch in the patient
information that comes with the patch (www.fda.gov/cder/drug/infopage/fentanyl/DuragesicPPI.pdf).
•
Do not use heat sources such as heating pads, electric blankets, saunas,
or heated waterbeds, or take hot baths or sunbathe while wearing a patch.
If your temperature is higher than 102 degrees while wearing a patch, call
the doctor right away.
For More Information:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentanyl
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