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FDA
Public Health Advisory
Safety Warnings Regarding Use of Fentanyl Transdermal (Skin) Patches
FDA is investigating reports of death and other
serious side effects from overdoses of fentanyl in patients using
fentanyl transdermal (skin) patches for pain control. Deaths and
overdoses have occurred in patients using both the brand name
product Duragesic and the generic product. The directions for using
the fentanyl skin patch must be followed exactly to prevent death or
other serious side effects from overdosing with fentanyl. These
directions are provided in the
product label and patient package insert.
Some patients and health care providers may not be fully aware of
the dangers of this very strong narcotic painkiller. Therefore, FDA
is issuing this public health advisory to alert patients and their
caregivers and health care professionals by highlighting the
following important safety information:
-
Fentanyl skin patches are very strong narcotic (opioid)
painkillers that may cause death from overdose. The fentanyl skin
patch should always be prescribed at the lowest dose needed for pain
relief.
-
Fentanyl skin patches should not be used to treat
short-term pain, pain that is not constant, or for pain after an
operation. Fentanyl skin patches should only be used by patients who
are already taking other narcotic painkillers (opioid tolerant), and
who have chronic pain that is not well controlled with
shorter-acting painkillers.
-
Patients who are using the fentanyl skin patch
and their caregivers should be told about the directions for safe
use of the patch and should follow the directions exactly. These
directions are provided in the
patient package insert
-
Patients who are using the fentanyl skin patch and
their caregivers should be told about safe methods for storage and
disposal of used, unneeded or defective fentanyl skin patches. Fentanyl skin patches should be stored in a safe place and kept out
of the reach of children. Safely dispose of used, unneeded or
defective fentanyl skin patches by folding the sticky side of the
patch together (until it sticks to itself) and flushing it down the
toilet.
-
Health care professionals who prescribe the fentanyl
skin patch and patients who use the fentanyl skin patch and their
caregivers should be aware of the signs of fentanyl overdose. Signs
of fentanyl overdose include trouble breathing or shallow breathing;
tiredness, extreme sleepiness or sedation; inability to think, talk
or walk normally; and feeling faint, dizzy or confused. If these
signs occur, patients or their caregivers should get medical
attention right away.
-
A patient using the fentanyl skin patch may have a
sudden and possible dangerous rise in their body level of fentanyl
or have a stronger effect from fentanyl if they: use other medicines
that affect brain function; drink alcohol (beer, wine or distilled
spirits); have an increase in body temperature or are exposed to
heat; or use other medicines that affect how fentanyl is broken down
in the body. These factors are described further in the product
label.
In June 2005 the Duragesic product label was updated
to add new safety information in several areas of labeling, and a
“Dear Healthcare Professional” letter about these changes was issued
by the manufacturer and is available at this link (http://www.fda.gov/medwatch/SAFETY/2005/duragesic_ddl.pdf).
FDA continues to work with the manufacturers of these products to
identify and manage factors that contribute to fentanyl overdose
from use of the fentanyl skin patch. Updates will be provided as new
information is available. Back
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Date created: July 15, 2005, updated December 21, 2007 |
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