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New Warnings on Propoxyphene Overdose

Started by ronr, September 06, 2009, 08:13:00 AM

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FDA is taking action to reduce the risk of fatal overdoses in patients taking the pain medication propoxyphene, an ingredient in drugs such as Darvon and Darvocet. Some European studies have indicated that propoxyphene may be more lethal than other pain medications when taken in higher-than-recommended doses. Because of these concerns, FDA is requiring manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, to emphasize the danger of overdosing. Manufacturers will also be required to develop a Medication Guide to be given to patients with each prescription, that stresses the importance of using the drugs only as directed.

Based on the available evidence, FDA believes that the benefits of using propoxyphene for pain relief outweigh the risks when it is taken at recommended doses. But FDA also recognizes that more safety information is needed about propoxyphene's effects at higher doses, especially on the heart. And so the manufacturer will be required to conduct a safety study to provide more information on this potential risk. FDA will also work with other Federal agencies to explore additional sources of data for comparing propoxyphene's safety with other pain medications.

In the meantime, physicians and patients need to be aware of the possible danger involved if propoxyphene is taken at doses higher than those in the labeling.

Additional Information:

    * FDA MedWatch Safety Alert. Propoxyphene-containing Products. July 7, 2009.

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