Safety Alerts & Recalls

What does this mean?

The FDA has determined that the heart related risks of propoxyphene outweigh the pain relieving benefits of this medicine and recommends that patients no longer use this medicine. If you currently take a propoxyphene-containing products, you should:

1) Talk to your healthcare professional about discontinuing propoxyphene and switching to alternative pain medicines.

2) Talk to your healthcare professional if you have any concerns about propoxyphene.

3) Contact your healthcare professional right away if you experience an abnormal heart rate or rhythm or other symptoms including dizziness, lightheadedness, fainting or heart palpitations.

4) Report any side effects with propoxyphene to FDA's MedWatch Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

5) Dispose of unused propoxyphene in your household trash by following the recommendations outlined in the Federal Drug Disposal Guidelines. Take your propoxyphene out of its original container and mix it with an undesirable substance, such as used coffee grounds or kitty litter. The medication will be less appealing to children and pets, and unrecognizable to people who may intentionally go through your trash. Put the medication in a sealable bag, empty can, or other container to prevent it from breaking out of a garbage bag. More information about disposing of unused medicine can be found at this website: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm226353.htm

FDA Recommends Against the Continued Use of Propoxyphene (Darvon, Darvocet, and Others)

On November 19, 2010, the U.S. Food and Drug Administration (FDA) announced that it intends to withdraw the pain medicine propoxyphene from the United States market, because this drug may cause serious toxicity to the heart. The FDA is basing this decision on new study information that shows propoxyphene can cause significant changes to the electrical activity of the heart, even when the drug is used at therapeutic doses. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms.

At this time, Xanodyne Pharmaceuticals Inc., which makes Darvon and Darvocet, the brand version of propoxyphene, has agreed to withdraw the medication from the U.S. market. The FDA has notified the generic manufacturers and requested that they voluntarily remove their propoxyphene products as well.

Propoxyphene is an opioid pain reliever used to treat mild to moderate pain. It is sold under various names as a single-ingredient product (Darvon) and as part of a combination product with acetaminophen (Darvocet). Propoxyphene is also known by such names as Dolene, Propacet 100, Wygesic, Trycet, Genagesic, E-Lor, and Balacet.

To answer some of the questions and concerns about this decision, the FDA has published a web page titled "Questions and Answers: FDA recommends against the continued use of propoxyphene." To view the FDA's Question and Answer web page, please visit: more information here

For more information, please visit: more information here

Source: FDA
Publication Date: 2010-11-19
Last Updated: 2010-11-19
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