US issues new warning on misuse of pain patch

Last Updated: 2007-12-21 13:01:15 -0400 (Reuters Health)

By Lisa Richwine

WASHINGTON (Reuters) - U.S. health officials issued a second warning on Friday about reports of deaths and dangerous side effects in patients who used Johnson & Johnson's Duragesic pain-killing skin patch or generic versions.

The Food and Drug Administration said it "has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or patients have incorrectly used it."

The patch contains a potent narcotic called fentanyl, which is delivered through the skin. It was approved in 1990 for patients with persistent, moderate-to-severe pain who find other opioid painkillers inadequate. The patch is most commonly prescribed for patients with cancer, the FDA said.

Reports to the FDA describe deaths and dangerous side effects after doctors prescribed the patch inappropriately to relieve pain after surgery, for headaches or for occasional or mild pain in patients who could have been treated with other opioid painkillers, the agency said.

In some cases, patients replaced the patch more often than directed, applied more patches than prescribed or applied heat to the patch, which led to dangerously high fentanyl levels in the blood, the FDA said.

The agency said it was asking all manufacturers of fentanyl patches to update safety information and issue a patient-friendly guide to highlight the risks.

Greg Panico, a spokesman for Johnson & Johnson unit Ortho-McNeil, said the company would strengthen the product warnings and develop the patient guide. "We've been working with the FDA on these changes," he said.