Duragesic Fentanyl Patch Recall

The manufacturer of the Duragesic patch, Johnson & Johnson's subsidiary PriCara, announced the recall December 31, 2008. At the same time, PriCara said the company identified a problem with the manufacturing equipment, causing patches to have a cut edge and a possible release of fentanyl gel.

The recall affects all Duragesic patches with an expiry date on or before December 2009. One lot of 50 microgram/hour (mcg/hr) Duragesic (fentanyl transdermal system) CII patches (lot number 0817239 ) sold by PriCara in the US and one lot of 50 mcg/hr fentanyl patches sold by Sandoz Inc. (lot number 0816851) were recalled.

The Duragesic pain patch was first approved by the Food and Drug Administration in August 1990 to treat certain patients with chronic pain. The Duragesic-brand patch is manufactured by Alza Corp., which is owned by Johnson & Johnson. Several generic versions of the pain patch, marketed under the name fentanyl, are also sold by several other companies.

This is the 5th recall of the duragesic transdermal pain patches since 1994. In February 2008, 95 lots of 25 mcg/hr Duragesic pain patch products and generic Sandoz fentanyl patches were recalled because they were not properly cut. Just one month later, another drug company, Actavis Inc., announced that its subsidiary (Actavis South Atlantic LLC) was proceeding with the voluntarily recall from wholesalers and pharmacies of all lots of Fentanyl transdermal system CII patches sold in the US.

In the wake of these recalls, hundreds of lawsuits have been filed against the manufacturers of fentanyl pain patches. Currently, more than 60 suits are pending against Johnson & Johnson and its subsidiaries; in the first four lawsuits that went to trial, the drug maker was ordered to pay more than $35 million to the families of individuals who died.

Who Uses the Fentanyl Pain Patch?

According to the FDA, fentanyl is about 80 times stronger than morphine. The pain patch delivers a steady dose of fentanyl (a powerful opiate pain medication), over an extended period of time, to persons suffering from chronic and/or debilitating pain, patients who have chronic pain that is not well controlled with shorter-acting painkillers, and/or patients who have developed a tolerance to opiod treatment.

Due to the dangerous nature of the drug, in June 2005 the Duragesic product label was given a black-box warning label explaining the risk of accidental fatal overdose and respiratory depression or hypoventilation. Patients and their caregivers have been advised to follow directions exactly from the patient package insert.

Fentanyl Overdose Symptoms

Symptoms of a fentanyl overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness or coma, confusion, tiredness, cold and clammy skin, and small pupils. Continued exposure to uncontrolled amounts of fentanyl can lead to addiction and dependency. The opioid drug stays in the system for up to 72 hours. As well, there are warnings of withdrawal side effects and potential damage to the cardiovascular system (bradycardia) and the central nervous system. Long term side effects of Fentanyl are not known.