Duragesic Patch Injuries

Duragesic and Durogesic are the trade names of fentanyl transdermal therapeutic systems, and are used for moderate to severe pain relief. Since Duragesic/Durogesic release fentanyl, a potent opioid, slowly through the skin, one patch may provide 72 hours of pain relief. It's initial onset after a patch has been applied is roughly 8-12 hours under normal conditions, thus Duragesic patches are often prescribed with another opioid (such as morphine sulfate) to handle breakthrough pain.

Contents
1 Approval and usage
2 Warnings
3 Recalls
4 Legal action
5 External links 

Approval and usage
Durogesic was first approved by the CBG in the Netherlands on 17 July 1995 as 25, 50, 75 and 100 µg/hour formulations, and on 27 October 2004 the 12 µg/hour formulations was approved as well. On Jan 28, 2005, the U.S. Food and Drug Administration approved first-time generic formulations of 25, 50, 75, and 100 µg/hour fentanyl transdermal systems (made by Mylan Technologies, Inc.; brand name Duragesic, made by Alza Corp.) The generic bioequivalent of Duragesic is available in 12, 25, 50, 75, and 100 µg dosages, while the trade names Duragesic and Durogesic are available in 12.5, 25, 50, 75, and 100 µg dosages. In some cases, physicians instruct patients to apply more than one patch at a time, giving a much wider range of possible dosages. For example, a patient may be prescribed a 37.5µg dosage by applying one 12.5µg patch and one 25µg patch simultaneously.

Duragesic is manufactured by ALZA Corporation and marketed by Janssen Pharmaceutica (both subsidiaries of Johnson & Johnson). During the period of June 2002 through June 2003, Duragesic sales totaled over one billion dollars.

Warnings
Since Duragesic and Durogesic are highly potent, there are many black box warnings in Duragesic's and Durogesic's prescribing information (PDF file). Additionally, due to the risk of serious adverse drug reactions, it is highly important that the patches be applied correctly and as prescribed.

In July of 2005, the FDA issued a Public Health Advisory, which advised that "deaths and overdoses have occurred in patients using both the brand name product Duragesic and the generic product." In December of 2007, as part of this continuing investigation, the FDA issued a second Public Health Advisory stating, "The FDA has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or after people incorrectly used it."

Recalls
In February 2004, a leading fentanyl supplier, Janssen Pharmaceutica Products, L.P. recalled one lot of fentanyl (brand name: Duragesic) patches due to of seal breaches which may allow the drug to leak from the patch. The recall notice warned that "exposure to the Duragesic hydrogel contents could result in an increased absorption of the opioid component, fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness, or potentially life threatening complications." Janssen also later recalled additional lots; a series of Class II Recalls were then initiated in March 2004 due to a potentially life-threatening manufacturing defect. At least one fatality, possibly due to the defect, has been reported to the American FDA.

The 25 mcg/hr Duragesic patches manufactured by ALZA Corporation were also recalled in February 2008 due to a concern that small cuts in the gel reservoir could result in accidental exposure of patients or health care providers to the fentanyl gel. Overexposure in patients, or even slight exposure in non opioid tolerant people, could possibly result in a fatal overdose. [1]

Legal action
On June 19, 2007, a $5.5 million jury verdict was awarded in a case against Johnson & Johnson subsidiaries, Alza Corporation and Janssen Pharmaceutica Products, the manufacturers of the Duragesic fentanyl transdermal pain patch. This case, the first Federal trial involving the Duragesic fentanyl patch, was tried in the Federal District Court for the Southern District of Florida, West Palm Beach Division.

....