The Duragesic (fentanyl transdermal system) patch is indicated 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 nonsteroidal analgesics. Approved by the Food and Drug Administration (FDA) in 1990, Duragesic releases fentanyl, a strong opioid, through the skin at a fixed rate for 72 hours. The patch is available only by prescription.

On July 15, 2005 the FDA issued a Public Health Advisory concerning the safe use of Duragesic patches, in response to reports of deaths in patients using this potent narcotic medication for pain management. The FDA is conducting an investigation into the deaths associated with these patches.

The FDA has been examining the circumstances of product use to determine whether the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product. It is possible that some patients and their healthcare providers may not be completely aware of the dangers of these potent narcotic drug products or the important recommendations regarding their safe use.

There has been an expanded recall of Duragesic patches due to possible leaks. Janssen Pharmaceutica notified healthcare professionals of an expanded recall of Duragesic 75 mcg/h, in February 2004. Four additional lots are subject to the present expanded recall. Some patches from the recalled lots may leak medication due to improper sealing of one of their edges.

If the medication leaks out of the patch, exposure to the medication can result in inadvertent ingestion or increased transdermal absorption of the active opiate component fentanyl, leading to potentially life-threatening complications. In addition, leakage of the medication could lead to inadequate dosing, resulting in treatment failure and/or opiate withdrawal.

Only patients who are already on and tolerant to opioid therapy and who require continuous opioid administration should use the patch.