Drug Recall Alert: PriCara Fentanyl Transdermal System

Fentanyl Is To Be Delivered Onto The Skin In A Controlled Fashion Where It Is Absorbed

On February 12, 2008, PriCara, a division of Ortho-McNeil-Janssen Pharmaceutical and part of the Johnson & Johnson group, issued a recall for all lots of 25 microgram/hour dose Duragesic. This included the same product sold as an authorized generic as well as those sold in Canada. These were all manufactured by Alza, an affiliate of the pharmaceutical company, and had an expiration date on or before December 2009.

The action was performed in cooperation with the U.S. Food and Drug Administration (FDA). The Canadian regulatory authority, Health Canada, also issued a public health warning against using these products.

Duragesic is a type of fentanyl transdermal system prescribed by doctors for patients with the most severe chronic pain. These are generally only prescribed when lesser painkillers have proved ineffective. The most common prescriptions are to those conditioned to narcotic medications, such as cancer patients.

Fentanyl is an opioid about 100 times more powerful than morphine. It is stored in gel form in a reservoir inside the Duragesic patches, which are intended to deliver the painkiller over a period of about 72 hours. However, a defective fentanyl transdermal system carries the risk of serious adverse effects, including overdose.
According to PriCara, the recalled patches may have contained a cut along one side of the drug reservoir. This cut means a possibility that the gel could leak out of the reservoir and into the packaging pouch, exposing someone to the narcotic directly as opposed to on a time-released system. This defect would also cause ineffective pain relief.

Exposure to the gel directly can lead to serious adverse effects, including respiratory depression and a potentially fatal overdose. Symptoms are characteristic of a central nervous system depression, including slowed heartbeat and breathing, pinpoint pupils, clammy skin, loss of consciousness, and seizures. In many cases, the victim will stop breathing completely.

The 2008 recall was not the first for Duragesic. There have been a number since 1990 when it was originally approved in the United States. In April 2004, several lots of 75 microgram/hour doses were recalled finding that some were leaking along one edge. Additionally, one of PriCara’s generic competitors, Actavis, has had similar experiences.

The company advised during the recall that any of these found to have a cut or tear in the inner lining should be flushed. Patients should also wash any exposed skin with water, but not soap.

The FDA has been closely monitoring this and other fentanyl transdermal systems, including issuing safety warnings to physicians, and has required alterations to the packaging on several occasions. The prescribing information currently includes many black box warnings, which indicate that the medication carries a significant risk of serious or even life-threatening adverse effects.

Though the recalled products had an expiration date of on or before December 2009, any fentanyl patch should be carefully checked for any potential defects before use.