Safety Alerts & Recalls

What does this mean?

The FDA has concluded that the benefits of propoxyphene for pain relief at recommended doses outweigh the safety risks at this time. However, if you take Darvon Compound, it is a good idea to regularly review your pain medication use with your doctor to make sure you are getting the right level of pain relief and minimizing your risk of the problems linked to taking too much pain medication.

The most frequent side effects of too much pain medication include unexplained changes in thinking and behavior, shortness of breath, lightheadedness, dizziness, and extreme sleepiness that may make it difficult for someone to wake you up. If you experience any of these side effects, please contact your doctor as soon as possible and discuss your symptoms.

FDA Takes Actions on Pain Medications Containing Propoxyphene

Based on a review of data submitted and available to the FDA, the FDA is acting on concerns about an increased risk of fatal overdose in patients who use medications that contain propoxyphene, a medication used to treat mild to moderate pain. Propoxyphene is a widely prescribed medication of a group of drugs known as opioids and is an ingredient in Darvon, Darvocet, Darvon Compound, and other brands.

The FDA is requiring the manufacturers of propoxyphene-containing products to strengthen the label's boxed warning to address the risk of overdose with these products. These manufacturers will also be required to provide a medication guide to patients stressing the importance of using the drugs as directed. The FDA will continue to work with manufacturers and other government agencies (including Centers for Medicare and Medicaid Services (CMS) and the Department of Veterans Affairs (VA)) to conduct additional studies regarding the safety of products that contain propoxyphene as compared to other commonly used pain medications. The FDA will communicate its findings and will take appropriate regulatory action if needed.

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Source: FDA
Publication Date: 2009-07-14
Last Updated: 2009-12-05

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