Litigation

Fentanyl Painkiller Patches Recalled

By Angel L. Reyes, III

In several of my articles, I’ve talked about the dangers of the Duragesic Pain Patch containing the prescription painkiller, fentanyl. The Duragesic Patch, which is approximately 80 times more powerful than morphine, certainly does kill pain, but unfortunately, it also kills people.  In my last article I asked, “With all the severe side effects, and even deaths caused by this patch, what is it going to take before the manufacturer finally recalls this dangerous drug from the market?”  It seems they finally got a clue. All fentanyl pain patches have been recalled, including the 25-microgram-per-hour ones.  Read the AP article in its entirety below.

Painkiller Patches Recalled
By NATASHA T. METZLER
Associated Press Writer

WASHINGTON (AP) -- Patches containing the prescription painkiller fentanyl were recalled Tuesday, because of a flaw that could cause patients or caregivers to overdose on the potent drug inside.

Sold in the United States under the brand name Duragesic by PriCara and generically by Sandoz Inc., the recall includes all 25-microgram-per-hour patches with expiration dates on or before December 2009.

Some of the patches may have a cut in the lining of the internal reservoir where the drug is stored in gel form. If the fentanyl gel leaks into the drug's packaging, it could cause a patient or caregiver to come into direct contact with this powerful "opioid" drug. This could result in difficulty breathing and a potentially fatal overdose.

If this reservoir is cut, it can be seen when the foil pouch containing an individual patch is opened. Damaged patches should be flushed down the toilet and not handled. Skin that has been exposed to the gel should be thoroughly rinsed with water, but not washed with soap.

In December, the FDA put out its second warning in two years about the dangers of misusing the powerful drug.

The drug is intended for chronic pain in people used to narcotics, such as cancer patients, and can cause trouble breathing in people not used to this family of painkillers. Yet the FDA found cases where doctors prescribed it for headaches or post-surgical pain.

PriCara estimates that two patches out of every million included in the recall have the defect that causes the leak.

For details on Duragesic patches sold by PriCara, call 800-547-6446. For details on generic fentanyl patches sold by Sandoz, call 800-901-7236.

The recalled patches were also sold in Canada under the Duragesic brand by Janssen-Ortho Inc.Ranbaxy Laboratories Ltd.

All of the patches were manufactured by PriCara affiliate ALZA Corp. PriCara is a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

and generically by

Full post as published by Angel Reyes Blog on February 12, 2008 (boomark / email).