Law Articles

Return to Law Dictionary Index

FDA Warns of Dangers From Duragesic Patch Used for Pain

Source: U.S. Food and Drug Administration
Published: July 19, 2005

Food and Drug Administration warned Friday that the pain relief patch Duragesic could cause drug overdoses and said it was looking into reports of 120 deaths and other serious side effects from overdoses in patients using the skin patches for pain control.

Duragesic contains fentanyl, a strong opioid narcotic painkiller. Duragesic can cause serious side effects, including trouble breathing, which can be fatal, especially if used the wrong way. Directions for using Duragesic must be followed exactly to prevent death or other severe side effects that can happen from using too much (overdosing) fentanyl. These directions are provided in the

These safety precautions include but are not limited to patient education regarding signs of overdose, proper patch application, use of other medications while using the patch, safeguards for children, and proper storage and disposal.

The FDA said it is conducting an investigation into the deaths associated with these patches. 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. The agency said 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 and the important recommendations regarding their safe use.

The FDA is working closely with the manufacturers of fentanyl patches to fully evaluate the risks associated with their use and to develop a plan to help patients avoid accidental fentanyl overdose.

Read full story at U.S. Food and Drug Administration

Return to Health Law

Return to Law Dictionary Index