Duragesic Recall

In February 2004, the FDA and Janssen Pharmaceutica issued a Class I recall of 400,000 Duragesic patches after discovering that the patches often failed to adequately seal to the skin. This causes the drug to leak a harmful amount of fentanyl, the opioid drug contained in the patch.

Releasing too much fentanyl causes the user to experience intensified drug effects.

Alternatively, the FDA discovered that the defective seal could result in not enough fentanyl being delivered to the user, causing withdrawal symptoms of sleeplessness and abdominal pain.

On April 5, 2004, Janssen announced that it was issuing a second Duragesic recall because of a flaw that caused leakage of the active chemical fentanyl, a chemical 100 times more potent than conventional morphine.

This recall affected almost 2.2 million patches, about 20% of which were still in active use.

Duragesic is no longer the only fentanyl pain patch being marketed. On January 28, 2005, the FDA granted final approval for Mylan Laboratories to market a generic fentanyl transdermal system.

Johnson & Johnson has also begun to market a generic version of the fentanyl patch through an agreement with Sandoz. Other companies have applications pending at the FDA to market similar fentanyl patches. And thus, other generic versions may soon be available. Problems associated with these newer generic patches have also been reported.