Safety Alerts & Recalls

What does this mean?

Meridia will no longer be available on the U.S. market and patients taking Meridia should stop taking this medicine. Weight changes may occur in some patients after stopping Meridia. However, there are no known adverse effects of stopping Meridia.

If you currently take Meridia, you should:

1) Stop taking Meridia and talk to your healthcare professional about alternative weight loss and weight loss management programs.

2) Contact your healthcare professional right away if you experience pain in the chest, heart palpitations, abnormal heart rate or rhythm, or other symptoms including dizziness and lightheadedness. These can be early signs of heart attack or stroke.

3) Dispose of unused Meridia in your household trash by taking your Meridia out of its original container and mixing it with an undesirable substance, such as used coffee grounds or kitty litter. Place this mixture in a sealable bag, empty can, or other container to prevent it from breaking out of a garbage bag. Additional disposal information can be found in the Federal Drug Disposal Guidelines: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm226353.htm

4) Report any side effects with Meridia to FDA's MedWatch Program by phone 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

Abbott Laboratories Agrees to Withdraw Its Obesity Drug Meridia

Abbott Laboratories has agreed to voluntarily withdraw its obesity drug Meridia (sibutramine) from the U.S. market because of clinical study data indicating an increased risk of heart attack and stroke. The FDA requested the market withdrawal after determining that the small weight loss that people achieve on Meridia does not outweigh the risk of heart attack or stroke.

To view the FDA's Meridia Questions and Answers web page, please visit: more information here

For more information, please visit: more information here

Source: FDA
Publication Date: 2010-10-08
Last Updated: 2010-10-08

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