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Duragesic Patch

There has been an expanded recall of Duragesic Patches (fentanyl transdermal) 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 its 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.

The Duragesic 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.

Moreover, only patients who are already on and tolerant to opioid therapy, and who require continuous opioid administration should use the patch. Approved by the U.S. 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.

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