Duragesic Pain Patch

The Duragesic Pain Patch is used to manage persistent moderate to severe chronic pain that needs to be treated around the clock and which cannot be treated by: combination narcotic, short-acting, or non-narcotic pain treatment products. It should only be used by people who are receiving or have developed a tolerance to pain therapy with opioids.

On February 12, 2008, PriCara, a Division of Ortho-McNeil-Janssen Pharmaceuticals recalled all lots of 25 microgram/hour (mcg/hr) DURAGESIC� (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies.

The fentanyl patches being recalled may have a cut along one side of the drug reservoir within the patch. The result is possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches with cut edges by flushing them down the toilet, using caution not to handle them directly. Patches with a cut edge that have leaked gel will not provide effective pain relief.

Fentanyl Side Effects

respiratory depression

fatal overdose

coma

Duragesic Pain Patch History

Duragesic has been potentially linked to hundreds of accidental fentanyl overdoses and deaths. The Duragesic Fentanyl Pain Patch was approved in 1990. It's one of Johnson & Johnson's top selling drugs. Though it's only for those with severe pain it has been given to those with less severe pain who should not have been so prescribed.

In February of 2004, Johnson & Johnson recalled the Duragesic Fentanyl Patch for the same exact reason, a potential cut or breach along the side of the patch, which can release Fentanyl into the body.

In July of 2005, the FDA launched an investigation into the Duragesic Fentanyl Patch after 120 deaths were reported due to use of the Fentanyl patch.

The FDA followed up recently with a warning letter restating that the patch is only to be used for constant pain and only to be used by those who aren't getting relief from other pain killers.

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