Duragesic recall issued due to leaking fentanyl gel

By Austin Kirk
Posted February 13, 2008

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Yesterday, Johnson & Johnson issued a Duragesic recall for all lots of their 25 microgram-per-hour fentanyl patches. Some of the powerful painkilling patches could contain a cut in the lining of the internal reservoir where the fentanyl gel is stored. This may allow the gel to leak directly onto the skin, resulting in serious and potentially fatal problems, such as respiratory depression or a possible fentanyl overdose.

>>INFORMATION: Duragesic Recall Lawsuits

The announcement marks the fifth Duragesic recall since 1994. Hundreds of fentanyl overdose deaths have been suffered by users of the patch which could be attributed to inadequate warnings or production problems since the medication was approved by the FDA. This recall appears to have been caused by a manufacturing defect where the fentanyl patches were not properly put in place when they were cut.

>>INFORMATION: Fentanyl Patch Problems

The Duragesic patch is a powerful opioid painkiller, which is worn on the skin for extended periods of time. It is intended to treat severe chronic pain in people who are tolerant of such narcotics, such as cancer patients. However, it has also been prescribed frequently “off-label” for unapproved uses, such as management of temporary post-surgical pain or headaches. The FDA has issued several health alerts to physicians warning about the risk of overdose associated with the use of the fentanyl patch.

This weeks Duragesic recall applies to millions of 25 mcg/hr fentanyl patches which have an expiration date of December 2009 or before. About 80 lots of the patches have been distributed in the United States and 15 lots were distributed in Canada, with 400,000 units in each lot. The recall does not apply to other fentanyl patches with strengths of 12.5, 50, 75 and 100 micrograms-per-hour.

The Duragesic recall was issued by PriCara, which is a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., a unit of the mega-corporation Johnson & Johnson. Some generic forms of the patch sold by Sandoz, Inc., a unit of Novartis AG, were also impacted by the recall. The Sandoz fentanyl patches were manufactured by the same company which produced the defective brand name Duragesic patches.

Individuals who have 25 microgram-per-hour fentanyl patches have been advised to check the box or foil pouch to determine if it has an expiration date of December 2009 or earlier. Although the cut edge in defective patches can be seen upon opening the sealed foil pouch, users should not attempt to handle the potentially defective patches. If the skin does come into direct contact with fentanyl gel which leaks out, the area of the skin should be thoroughly rinsed with large amounts of water, but soap should not be used.

DURAGESIC RECALL LAWSUITS

The fentanyl lawyers at Saiontz & Kirk, P.A. are reviewing potential Duragesic lawsuits on behalf of individuals who suffered an overdose death after use of a fentanyl patch. To have a potential claim evaluated, request a free consultation.