Johnson & Johnson Pain Patch Recall - J&J sais Leak Can Cause Accidental Overdose

Recall Alert: February 13, 2008

Johnson & Johnson announced that it and Novartis AG's Sandoz unit are recalling patches comprising of  fentany because of possible cuts in the drug reservoir that could cause a leak and expose people.

The patches are produced by J&J's ALZA Corp., J&J said now in an assertion put out  today by PR Newswire. The patches release 25 micrograms of the drug in an hour. Other strengths aren't affected by the recall, which is voluntary, the company said. J&J's patches are of the the Duragesic brand.

The Food and Drug Administration issued a safety warning in December over the Duragesic and its generic equivalents, saying improper use continues to cause deaths and life-threatening difficulties breathing.

Fentanyl is mostly used to treat cancer pain, according to the FDA. The agency issued an alert on the patch in July 2005 after 120 patients taking the drug died.

The patches in the  recall from today have expiration dates on or before December 2009, according to Jhonson and Jhonson. This recall includes Canada, the New Brunswick, New Jersey, company said.Johnson & Johnson Duragesic Pain Patch Flaw Recall.

A recall has been issued by Johnson & Johnson and Novartis AG's Sandoz on 5-microgram-per-hour patches with expiration dates on or before December 2009.

It was found that a manufacturing problem led to some of the patches having a cut in the internal reservoir lining. This cut may cause a leaking problem of the patch.

The danger is if anyone touches a defective pain patch they may be delivered a dose of the prescription painkiller fentanyl which may lead to breathing problems or even an accidental overdose.

Back in December the FDA issued a safety warning on the Duragesic patch, citing improper use may cause breathing difficulties and death. The FDA continues to work with J& J on this voluntary recall and is investigating this latest issue.

The U.S. Food and Drug Administration issued a safety
warning in December over the patches, saying improper use can
cause breathing difficulties and death. That followed a July 2005
alert put out by the FDA after 120 patients taking the drug died.
Johnson & Johnson said in November that it faced 72 lawsuits over
the patches.

``The FDA continues to engage with the company in its
voluntary recall and is investigating the situation,'' FDA
spokeswoman Susan Cruzan said in an e-mail.

Johnson & Johnson rose $1.09, or 1.8 percent, to $62.97 in
New York Stock Exchange composite trading today. The shares have
fallen 5.6 percent this year.

The recall ``is small enough that I doubt this will impact
the bottom line,'' said Jon Fisher, a portfolio manager at Fifth
Third Asset Management in Minneapolis. The fund held 3.1 million
shares of Johnson & Johnson as of September, according to data
compiled by Bloomberg.

Fentanyl is mostly used to treat cancer pain, according to
the FDA, and doctors say it's a stronger painkiller than
morphine. Duragesic patches contain fentanyl in a pouch between
two membranes. In January, Johnson & Johnson received returned
patches that had cut edges, prompting the company to notify the
FDA, Panico said.

`Small Percentage'

``Patches that have this defect were not in place properly
when they were cut,'' Panico said in an interview. The 25-
microgram patches ``account for small percentage of sales,''
since Johnson & Johnson sells higher-dose versions, he said.

Different manufacturing problems caused Johnson & Johnson to
recall versions of the patches in 1994 and 1996, Panico said. A
2004 recall covered patches supplying 75 micrograms of the drug.

``At some point, the FDA is going to have to say five
strikes and you're out,'' said MacDonald, a partner at MacDonald,
Rothweiler & Eisenberg in Boston.

Reports of leaking patches have prompted the families of
some users who died to seek millions of dollars in damages from
Johnson & Johnson.

Juries in Texas and Florida concluded that defective patches
caused the deaths of Michaelynn Thompson and Adam Hendelson. A
Texas state court jury awarded Thompson's family more than
$772,000 in damages, and a federal jury in Florida ordered the
company to pay Hendelson's family $5.5 million.

More Information: Duragesic Fentanyl Patch