The Duragesic pain patch, manufactured by Janssen Pharmaceutical Products, is a medication delivery system intended to release the painkiller fentanyl into the skin over a period of a few days. A generic form of this patch (fentanyl transdermal skin patch) was brought out by Mylan Laboratories in 2005, and a later generic version was produced by Actavis, Inc. The Duragesic patch claim is that medication given through the skin goes directly into the bloodstream, bypassing the liver and stomach, which often means that lower doses are required. The Duragesic pain patch was approved by the FDA (Food and Drug Administration) in 1997.

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In 2004 Janssen recalled several batches of the Duragesic pain patch because of a faulty seal that can cause an overdose. More than 400,000 patches were involved in the recall. In 2008 patches marketed under the brand Duragesic by PriCara and as a generic product by Sandoz Inc. were recalled. That recall involved all 25-microgram-per-hour patches with expiration dates on or before December 2009. The patches were recalled because they might be cut and cause the gel to leak onto the skin of the patient or caregiver, causing serious injury or death. In 2008 Actavis Inc. recalled all its fentanyl patches with expiration dates between May 2009 and December 2009. These recalls have raised concern about whether these patches can be manufactured safely

The FDA issued a Public Health Advisory warning on July 7, 2005, saying that the FDA is investigating reports of death and other serious side effects from overdoses of the narcotic fentanyl in fentanyl transdermal skin patches.

Reports indicate that not only faulty seal, but factors such as heat, exercise, and fever can alter the dosage of narcotic released by these patches. Fentanyl, a drug up to 100 times more potent than morphine, is dangerous in high doses. See Duragesic Patch Information and Warnings for more information. The FDA has announced that at least 120 deaths have been linked to use of fentanyl patches.

In 2007 the FDA issued an additional safety warning.

Check out the following articles for more information about Duragesic Patch, filing a Duragesic Patch lawsuit and finding Duragesic Patch attorney.

• For more information about Duragesic Patch side effects, see Duragesic Patch Side Effects
• For more information about Duragesic Patch updates, see Duragesic Patch Information and Warnings
• To find out more about the FDA warning, see Duragesic Patch Side Effects and Risks
• If you would like to learn more about Duragesic Patch lawsuits, see Duragesic Patch Lawsuits, Litigation & Lawyers
• To learn more about Duragesic Patch attorneys and how to find one, see Hiring a Duragesic Patch Attorney and Lawyer

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