Overdoses from pain relief patch suspected in 120 deaths

WASHINGTON — Federal regulators are investigating about 120 reported deaths that may be linked to overdoses from a pain relief patch that administers a potent narcotic through the skin, the Food and Drug Administration said Friday.

Johnson & Johnson's Duragesic patch can provide up to three days' relief from severe chronic pain, such as that experienced by bone cancer patients. But fentanyl, its active ingredient, is highly dangerous.

An overdose of the morphine-like drug can put a patient into a coma and shut down breathing.

Fentanyl gained international notoriety in 2002, when Russian authorities trying to end a hostage crisis at a Moscow theater pumped in a gas reportedly containing the drug, intending to put the hostages and their Chechen captors to sleep.

Of the 750 hostages, about 120 died, nearly all from breathing the gas.

FDA officials said they are investigating whether the deaths among U.S. patients could be the result of unintentional fentanyl overdose.

Such overdoses could come about if patients and doctors do not faithfully follow a series of precautions contained in the prescribing literature, or label, for the drug.

Other possible explanations include rare problems or defects with the patches themselves that would cause too much of the drug to be released into the body too quickly.

Doctors and patients should be aware of the signs of fentanyl overdose, which include trouble breathing or shallow breathing, tiredness, extreme sleepiness, inability to think, talk or walk normally and feeling faint, dizzy or confused, the FDA said. Patients experiencing these symptoms should get medical attention right away, the FDA said.

"The way people die is that it decreases the drive to breathe, so people will not breathe effectively" said Meyer. "It (can) make patients very sedated, or comatose."

FDA officials said the agency announced the investigation in keeping with its new commitment to give the public warning of possible problems with prescription drugs. The FDA has been strongly criticized for taking too long to respond to evidence of heart attack risks with Vioxx and other arthritis drugs, and to evidence of suicide risks for teenagers taking anti-depressants.

The fentanyl investigation is in its early stages, FDA officials said, and the agency has reached no decision on whether the patches should be recalled, or their use limited.