Duragesic Patch Warning

FDA Release - July 2005

The Food and Drug Administration announced that Janssen Pharmaceutical is warning health care professionals about misusing Duragesic patch and is taking steps to restrict the patch's use. These actions come after a few isolated instances of misuse of the Duragesic patch were implicated in preventable patient deaths.

The company has sent a letter to all health care professionals, revised the product's labeling, added warning language to the product's packaging, and will revise patient instructions to include warnings of possible side effects. "There is evidence that this product is being misused in ways that put patients in danger," said FDA Commissioner David A. Kessler, M.D. "We are taking steps to protect future patients by making sure that the drug is prescribed safely."

Because serious or life-threatening breathing problems can occur, Duragesic is:

- Not to be used to manage acute or postoperative pain, including pain after outpatient surgery.
- Not to be used for mild or intermittent chronic pain that can be managed with less powerful drugs.
- Not to be started at a dose higher than 25 micrograms per hour.
- Not to be used by children under age 12, or by patients under age 18 who weigh less than 110 lbs., except in FDA-approved research settings.

Duragesic is to be used only for the management of severe, chronic pain (such as cancer pain) that cannot be managed with less powerful drugs such as acetaminophen-opioid combinations and non-steroidal analgesics. Moreover, the patch should be used only by patients who are already on and tolerant to opioid therapy, and who require continuous opioid administration.

The FDA approved the Duragesic patch in 1990. The patch releases fentanyl, a strong opioid, continuously at a fixed rate for 72 hours.