J & J Is Recalling a Pain Patch

Wall Street JournalJ & J Is Recalling a Pain Patch
The Wall Street Journal,
February 13, 2008.

Johnson & Johnson is voluntarily recalling a version of its blockbuster pain patch Duragesic because of manufacturing issues that could lead to accidental overdoses.

Duragesic, for patients experiencing moderate to severe chronic pain, contains fentanyl, an opioid that could lead to problems such as respiratory depression and fatal overdose.

The recall includes all 25 microgram-per hour patches that are sold in the U.S. by J&J PriCara unit and Sandoz; they are made by another J&J unit, Alza Corp.

In all about 32 million patches will be recalled PriCara estimates that two per million – 64 total – have the defect The Food and Drug Administration issued an alert about fentanyl patches in July 2005.

The issue involves a sliced edge in the pouch that contains the fentanyl gel, which could re¬sult in the gel leaking. That could result in an overdose or leave insufficient medicine.

A handful of product returns alerted PriCara to a possible problem in January, and the company "acted immediately;" says PriCara spokesman Greg Panico. No fatalities were reported, the company said. An FDA spokeswoman says, “The FDA continues to engage with the company in its voluntary recall and, is investigating the situation.

Recalls in 2004 were limited to some batches of the 75-micro-gram patch. The more-widely used 25-Microgram patch is pre¬scribed mainly for lower-weight patients, children and patients just starting on the medicine. Duragesic lost U.S. patent protection in 2005. Nonetheless the patch still brought in $1.16 billion in 2007, largely because international sales remain strong. J&J's follow-up pain medicine, called Ionsys, has been delayed coming to market in the U.S. because of manu¬facturing difficulties. In its most recent public filing with the Securites and Exchange Commission, J&J said 72 people have sued the company alleging injury from Duragesic. A case this past summer yielded a $5.5 million verdict. The recall may boost the hopes of plaintiffs’attorneys who are claiming that the product is responsible for dozens of deaths.

“Perhaps it is time for the FDA to consider removing the Duragesic patch from the American marketplace, because there are safer alternatives,” says Alex H. MacDonald of MacDonald, Rothweiler & Eisenberg, LLP, which has filed four wrongful-death suits related to Duragesic.

“We’re acting responsibly by recalling the defective lot,” says the PriCara spokesman, Mr. Panico, adding that the company can’t comment on pending lawsuits. “Despite the defect, there’s much unaffected product on the market and we think overall the patients have been served by this therapeutic option.”