Drug Recall Alert: Actavis Fentanyl Patch

Numerous Brands Of The Pain Patch All Have The Same Defect Allowing For Possible Overdose

On February 17, 2008, the pharmaceutical company Actavis, formerly known as Abrika Pharmaceuticals, announced a recall of 14 lots of their generic fentanyl transdermal system. The drugs may have had a fold-over defect, which can cause a leaking of the narcotic gel. They ranged from 25 to 100 mcg/hr doses and had expiration dates between May and August 2009. The product bore both the Actavis logo and an Abrika Pharmaceuticals label.

The recall occurred only days after PriCara, a division of Ortho-McNeil-Janssen Pharmaceutical and part of the Johnson & Johnson group, issued one of its own for the Duragesic brand. These potentially defective products may have contained a cut along one side of the drug reservoir, which could cause the gel to leak out of the reservoir and into the packaging pouch, exposing patients or their caregivers to the opioid directly. Duragesic patch side effects can be very serious.

Two weeks later, on March 3, 2008, Actavis extended the action to every remaining Actavis fentanyl patch being sold in the United States. The company noted that this was a “precautionary measure,” as they lacked assurance that all were free from defects. Again, the effected doses were between 25 and 100 mcg/hr, though the expiration dates expanded to span May to December 2009.

There are a number of different types of deficiencies possible in these products, according to information gathered by the FDA. The fold-over imperfection suspected in the Actavis fentanyl patches is one of several that can cause leaking. This direct exposure to the gel may lead to serious injury or even death.

Transdermal systems are only prescribed when other painkillers have proved ineffective for patients with severe chronic pain. Fentanyl is about 100 times stronger than morphine and should only be used by victims of this kind of “breakthrough pain,” such as cancer patients and others conditioned to narcotic pain medication.

The narcotic is in gel form and intended for release over a period of about 72 hours. In a transdermal system mcg refers to “micrograms,” and mcg/hr indicates the dose that is released over time. They come in doses of 25, 50, 75, and 100 mcg/hr. Any increase in a prescribed dose is very dangerous; an imperfection leading to a leak carries the risk of serious injury, including a potentially fatal overdose.

Slowed heartbeat and breathing, pinpoint pupils, clammy skin, loss of consciousness, and seizures are all signs. The victim could also stop breathing completely. The U.S. Department of Justice has reported hundreds of deaths from these overdoses.

This experience with defective products was not the first, and in fact, the Duragesic brand has had more than one since 1990 when it was originally approved in the United States. In April 2004, several lots of 75 microgram/hour doses were found to be leaking along one edge.

Actavis directed consumers to flush any damaged products that they discovered. They should also wash any skin exposed directly to the gel with water, but not soap. Anyone who experiences the symptoms of a fentanyl overdose after using one of these should immediately contact a medical professional.