Fentanyl

On Friday, July 15, 2005, the Food and Drug Administration warned that the pain relief patch Duragesic could cause drug overdoses and said it was looking into reports of 120 deaths and other serious side effects from overdoses in patients using the skin patches for pain control. Johnson & Johnson's Duragesic patch contains fentanyl a strong, opioid narcotic painkiller.

Deaths and overdoses have occurred in patients using both the brand name product Duragesic and the generic product fentanyl. The FDA believes that the chief cause of the deaths and overdoses of patients using fentanyl transdermal (skin) patches is lack of knowledge: The agency has stated that some patients and health care providers may not be fully aware of the dangers of the potent morphine-like drug. The directions for using the patch must be followed exactly to prevent death or other serious side effects.

The FDA has proposed precautions regarding the safe use of the patches, including 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.

Duragesic has been on the market since 1990, and the FDA said the 120 deaths reported to the agency spanned the entire period from 1990 to present.

Mylan Laboratories Inc. began marketing a generic version of the drug this year. The Duragesic patch can provide up to three days' relief from severe chronic pain, but an overdose of the morphine-like drug can put a patient into a coma and shut down breathing. In addition to trouble breathing or shallow breathing, here are other signs of fentanyl overdose:

• Tiredness
• Extreme sleepiness
• Inability to think, talk or walk normally
• Feeling faint, dizzy or confused

People experiencing the symptoms should get medical attention immediately.

The FDA also alerted doctors that they should prescribe the lowest effective dose of the medication, and that the patches should not be used to treat short-term pain or pain after an operation. Patients should not use patches that are damaged or broken, the FDA said. They also should not drink alcoholic beverages or sit in the sun while taking the drug, because alcohol and a rise in body temperature can accentuate the narcotic effects.

While the FDA is primarily targeting patient education, it is not ruling out the possibility that problems or defects with the patches may have caused some of the 120 deaths. 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.

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