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Sibutramine Withdrawn from Market Per FDA(Meridia)

Posted by Phillipa on October 8, 2010, at 15:27:58 [reposted on October 12, 2010, at 13:38:54 | original URL]

The weight loss med sibtramine (meridia) was withdrawn from market today per Fda to Abbott. Phillipa

Abbott Withdraws Sibutramine From Market
Robert Lowes

October 8, 2010 Abbott Laboratories has withdrawn the obesity drug sibutramine (Meridia) from the market in light of clinical trial data pointing to an increased risk for stroke and myocardial infarction, the US Food and Drug Administration (FDA) announced today.

The agency asked Abbott Laboratories to pull the drug from the market after it evaluated data from a postmarketing study of the drug's cardiovascular safety. The study, called the Sibutramine Cardiovascular Outcomes Trial (SCOUT), demonstrated a 16% increase in the risk for serious cardiovascular events such as nonfatal heart attack, nonfatal stroke, the need for resuscitation after the heart stopped, and death in a cohort of patients given sibutramine compared with another given a placebo.

The FDA is advising physicians to stop prescribing sibutramine and for patients to stop taking it and talk to their healthcare provider about alternative weight-loss regimens.

More information about today's announcement is available on the FDA's Web site.

To report adverse events related to sibutramine, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.




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