FDA Renews Warnings on Pain-Relief Patch

By Steven Reinberg
HealthDay Reporter
Friday, December 21, 2007; 3:00 PM

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FRIDAY, Dec. 21 (HealthDay News) -- For the second time in two years, U.S. health officials are warning of reports of deaths and dangerous side effects tied to misuse of fentanyl skin patches that are prescribed to treat chronic pain.

The patches deliver a potent pain killer containing the narcotic fentanyl. They are primarily used by cancer patients who are tolerant to the side effects of narcotic pain medications, according to U.S. Food and Drug Administration officials who issued Friday's warning.

"There are a small number of cases [of deaths and life-threatening side effects] that are very concerning, because they are preventable," Dr. Bob Rappaport, the FDA's director of the Division of Anesthesia, Analgesia and Rheumatology Products, said during a morning teleconference.

"Unfortunately, we are still seeing prescribers giving these patches to patients who are not opioid-tolerant, or for treatment post surgery, for mild pain. We've even seen cases for headache," Rappaport said. "There are still cases of patients who are not using the product correctly."

Rappaport could not say how many cases of death or life-threatening side effects have been caused by fentanyl patches since the agency issued its first warning in July 2005.

Fentanyl skin patches are only for use with patients who have become used to narcotic drugs and are less likely to have side effects, such as difficulty breathing, Rappaport said. "That's why somebody who has been on high-dose opioids for a long time can get large doses that would be a fatal dose in somebody who had never been exposed to opioids," he said.

However, recent reports describe deaths and life-threatening side effects after patches were inappropriately prescribed to relieve pain after surgery, for headaches, and for occasional or mild pain in patients who were not opioid tolerant, he said.

In some cases, patients used the patch incorrectly -- replacing it more frequently than directed, using more patches than prescribed, or applying heat to the patch. These all can cause dangerously high fentanyl levels in the blood, according to the FDA.