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Duragesic Lawsuit

A public health advisory on Duragesic (fentanyl) was issued on July 15, 2005 by the U.S. Food and Drug Administration while the agency was investigating about 120 deaths that may have been related to the use of the transdermal pain patches.

In a statement, the FDA said in part: "The agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product. It is possible that some patients and their health care providers may not be completely aware of the dangers of these potent narcotic drug products ..." (See the full FDA statement below.)

The FDA was looking into reports of deaths and serious side effects caused by overdosing and cited deaths among patients who took the brand name Duragesic, made by a division of Johnson & Johnson, and fentanyl, the generic form of the opioid analgesic manufactured by Mylan Laboratories.

According to one report, in the health news website medpagetoday.com, the FDA said it "has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product."

Signs of Duragesic/fentanyl overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness or coma, confusion, tiredness, cold and clammy skin, and small pupils. Continued exposure to uncontrolled amounts of fentanyl can lead to addiction and dependency.

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