FDA Warns Again on Fentanyl Patches
Second Warning Reminds Patients to Use the Painkiller Exactly as Directed
Dec. 21, 2007 -- Spurred by patient deaths and life-threatening side
effects, the FDA today issued its second warning about misuse of skin patches
containing the painkiller fentanyl.
Fentanyl is a prescription opioid drug. Fentanyl skin patches are sold under
the brand name Duragesic and in four generic products.
Today's FDA warning is specific to fentanyl patches -- not other forms of
fentanyl -- and applies to Duragesic and generic fentanyl patches.
The FDA's key message: Fentanyl skin patches must be prescribed and used
exactly as directed, and only by patients whose bodies have become able to
tolerate opioids, reducing the risk of serious side effects.
Second Fentanyl Patch Warning
The FDA issued a
similar warning in July 2005.
"Unfortunately, we still do continue to see cases of patients using the
product incorrectly and prescribers prescribing the product incorrectly,"
Bob Rappaport, MD, director of the FDA's division of anesthesia, analgesia, and
rheumatology products, said in a news conference.
"Some of these cases have resulted in life-threatening events and some
even in death," says Rappaport, adding that the FDA will provide the number
of those cases in the next week or so.
Some cases are related to prescribers who prescribe the patches for patients
who aren't opioid-tolerant. In other cases, patients use the patches
"For instance, they cannot be used in a setting where they would be
exposed to heat, such as with a heating pad or a hot tub or a heated water
bed," says Rappaport. "That increases the amount of the drug that's
absorbed from the patch and can cause a life-threatening situation."
Patients and prescribers need to fully understand how to use fentanyl
patches, says Rappaport.
Fentanyl Overdose Symptoms
The FDA wants doctors and patients to learn the symptoms of fentanyl overdose, including:
- Trouble with breathing, or slow or shallow breathing
- Slow heartbeat
- Severe sleepiness
- Cold, clammy skin
- Trouble with walking or talking
- Feeling faint, dizzy, or confused
Patients using the fentanyl patch who experience those symptoms should get
medical attention right away, says the FDA.
Patients or caregivers should call the patient's doctor immediately if the
patient's temperature exceeds 102 degrees while wearing a fentanyl patch, the