So far, the Food and Drug Administration has issued two warnings about the risk of overdose from the Duragesic pain patch.
In July 2005, after investigating 120 deaths linked to the use of the Duragesic patch, the FDA alerted patients and health care providers of the potentially fatal dangers of the fentanyl-releasing skin patch.
Despite this warning, the FDA said that it continued to receive reports of overdose and death from patients who misuse the Duragesic patch. The company issued a second warning in December 2007 stating that patients who use too many fentanyl patches, replace them more often than directed or who expose the patch to heat (such as in a shower or hot tub) are at an increased risk of death from a fentanyl overdose.
The Duragesic patch (made by Janssen Pharmaceutica, a subsidiary of Johnson & Johnson) is prescribed as a powerful pain medication to manage chronic aches by giving a constant dose of fentanyl, an opioid drug. The transdermal patch steadily releases the medication through the skin and into the bloodstream.
120 deaths had been linked to the use of the Duragesic patch as of July 2005.
FDA approval, then side effects
The Duragesic patch was approved for use by the FDA in 1990; users of the patch were initially informed of side effects that included:
• Vomiting
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• Dry mouth |
| • Drowsiness |
• Hypotension |
| • Weakness |
• Loss of appetite |
| • Constipation |
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The FDA has since associated the Duragesic patch with more serious side effects including extreme sleepiness and even death. A Duragesic lawsuit was resolved on July 8, 2006, as a jury found Johnson & Johnson responsible for the death of a woman who used the Duragesic patch.
Jurors awarded damages to the victim’s daughter after a defective patch released 10 times the therapeutic amount of fentanyl into her body.
There was a partial recall of Duragesic in 2004, but it is still on the market. If you or a loved one have been injured by using the Duragesic patch, call the law office of Sam Levine at (888) 404-LAWYER.
Or you may fill out our online contact form.