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2/17/2004

Leaky Fentanyl Patches Recalled

Kate Traynor

Janssen Pharmaceutica Products yesterday announced an urgent recall of a single lot of the company's Duragesic fentanyl transdermal patch.

According to the recall notice, some patches in Duragesic-75 lot number 0327192 were improperly sealed along one edge and may leak medication. Duragesic-75 releases 75 mcg of fentanyl per hour for 72 hours; before use, the intact patch contains 7.5 mg of fentanyl.

Janssen stated that the leakage could result in excessive absorption of fentanyl through the wearer's skin, causing adverse events such as "nausea, sedation, drowsiness, or potentially life-threatening complications." If fentanyl leaks from the patch before it is applied to the skin, insufficient analgesic could be absorbed to control the wearer's pain.

The company also stated that health care providers who come into contact with medication that leaked from a patch are at risk for adverse events associated with exposure to opiates. If such contact occurs, Janssen recommends thoroughly rinsing the exposed skin with water, not soap.

Anyone who is using a recalled patch should remove it and promptly apply an intact patch, according to the company. Janssen noted that prompt replacement of the damaged patch is necessary to avoid symptoms associated with sudden discontinuation of the product.

Janssen recommends that rubber gloves be worn while removing the damaged patch or that a tissue be used to protect the skin of the person who removes the patch. The patient's skin should be wiped gently with a soft cloth and rinsed with water, and a new patch applied immediately.

Janssen's Web site includes images of the recalled product and instructions for locating the patches' lot number. According to instructions at the company's Web site, pharmacists and other health care providers should help patients determine whether their patches are included in the recall.

The company has instructed patients to return unused, unopened patches to their pharmacist, and stated that an announcement of Janssen's return policy will be forthcoming.