FDA warns on pain patch

WASHINGTON, Jul 15, 2005 (United Press International via COMTEX) -- The Food and Drug Administration is warning consumers that deaths have been associated with use of the pain management medication transdermal fentanyl.

The Los Angeles Times reported federal regulators are investigating about 120 death that may be associated with Johnson & Johnson's Duragesic patch -- which can provide up to three days' relief from severe chronic pain. Fentanyl, the patch's active ingredient, can put patients into a coma and shut down breathing in too-high doses, the newspaper said.

The FDA issued a Public Health Advisory and an alert to healthcare professionals on what it described as the "potent narcotic medication," identifying safety precautions for its use.

"These safety precautions include but are not limited to patient education regarding signs of overdose, proper patch application, use of other medications while using the patch, safeguards for children and proper storage and disposal," said the FDA in a statement Friday.

FDA investigators are trying to determine whether the deaths were related to inappropriate use of the patch or "factors related to the quality" of the product.

"It is possible that some patients and their health care providers may not be completely aware of the dangers of these potent narcotic drug products and the important recommendations regarding their safe use," said the FDA.