FEBRUARY 14, 2008 ALERT:

Johnson and Johnson has issued a recall on its Duragesic Pain Patch after it was found that a leak of the active ingredient, Fentanyl, could prove potentially fatal to patients or those around them.

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Flawed Duragesic Pain Patches Recalled Because Of Potential For Lethal Overdose

A unit of Johnson & Johnson has announced a voluntary recall of its Duragesic pain patch over fears that a leak could expose patients or caregivers to a lethal dose of a potent painkiller.

The recall, announced Feb. 12, is being conducted in cooperation with the U.S. Food and Drug Administration. News reports indicate that as many as 32 million of the Duragesic pain patches could be recalled. An estimated two patches out of every million may leak.

The recall is for the Duragesic 25 microgram-per-hour patches with expiration dates on or before December 2009. All are manufactured by ALZA Corporation. Also on the recall list is a generic Sandoz Inc. 25 microgram-per-hour pain patch.

The Duragesic and Sandoz patches contain the painkiller fentanyl. That Schedule II opioid medication was originally approved in 1990 to treat acute, postoperative and moderate-to-severe pain. Applied to the skin, the Duragesic adhesive patch delivers a powerful and constant dose of fentanyl in gel form, providing pain relief for up to 3 days.

The problem, according to a press release on Johnson & Johnson’s Web site: the recalled patches may have a cut along one side of the drug reservoir within the patch, allowing the gel to seep out. The cut edge in affected patches can be seen upon opening the sealed foil pouch that holds the patch. At least six defective patches have already turned up.

The leak has the potential to deliver a deadly dose of the drug. Too much fentanyl gel can lead to “serious adverse events, including respiratory depression and possible overdose, which may be fatal,” the recall notice said.

The company warned anyone who comes in contact with fentanyl gel to “thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches with cut edges by flushing them down the toilet, using caution not to handle them directly.”

Patches with a cut edge that have leaked gel will not provide effective pain relief, the press release said.

Patients with the recalled 25 mcg/hr Duragesic patches were asked to call (800) 547-6446, while patients with the recalled 25 mcg/hr Sandoz Inc. patches were asked to call (800) 901-7236.

This is not the first time that pain patches have made headlines. Janssen Pharmaceutica Products, owned by Johnson & Johnson, issued a recall of all of their 75mcg/hr Duragesic patches in February 2004 due to a potential breach in the seal on one edge of the patch.

In July 2005, the FDA launched an investigation after 120 deaths were linked to patches which utilized fentanyl for pain control. And last December, the U.S. Food and Drug Administration issued a safety warning about the patches, saying improper use could cause breathing difficulties and death.

You should be alert to the possibility of receiving a defective patch and its associated risks of overdose or inadequate control of pain. If you or someone you love believes they have experienced adverse effects resulting from the Duragesic patch, it is important to contact your doctor for health advice. It is also in your best interests to consult with a qualified personal injury attorney who can help protect your legal rights. It is important to act quickly since there may be a limited timeframe in which to file a claim. When you need top-notch legal skills and the support of an experienced team of professionals -- call Brown & Crouppen.

At Brown & Crouppen our experienced team of defective drug lawyers provides tough, aggressive representation for Duragesic pain patch victims and their families. When you choose us to handle your lawsuit, our entire team becomes fully committed to your cause. We’ll find answers, hold negligent companies responsible and get you the compensation you deserve.

Brown & Crouppen can help you make informed decisions about your legal rights, so please call Brown & Crouppen at Toll Free: 866-991-4700 for your free legal consultation or save time with our online Contact Form.