Abbott Laboratories is retirement of the obesity Drug Meridia

SILVER SPRING, Maryland, October 8,/PRNewswire-USNewswire/--Abbott Laboratories has accepted the voluntary obesity drug Meridia (sibutramine) to pull out of the American market because of the clinical trial data that an increased risk of heart attack and stroke, the u.s. food and drug administration, announced today.

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"Meridia continued availability is not justified when you compare the very modest weight loss that people on this drug their risk of heart attack or stroke," said John Jenkins, m.d., Director of the Office of the new drugs in the FDA Center for Drug Evaluation and Research (CDER)."Doctors are advised to stop to prescribe Meridia to their patients and patients should stop taking this medication. patients should talk with their health care provider about alternative weight loss and maintenance programs of the loss of weight."

Meridia in november 1997 was approved by the FDA for weight loss and maintenance of weight loss in obese people, as well as in some overweight people with other risks for heart disease.The approval is based on clinical data showing that more people received sibutramine lost at least 5% of their body weight than people on placebo that are on a diet and exercise alone.

The FDA requested the market after reading of data from the Sibutramine BOY SCOUTS (cardiovascular outcomes trial). SCOUTING has been set up as part of a postmarket cardiovascular safety of sibutramine requirement after a look to the European approval of these drugs. the process demonstrated an increase of 16% of the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated as soon as the heart stopped and dead, who in a group of patients receive sibutramine in comparison with other placebo. There was a slight difference in the weight loss between the placebo group and the group that received sibutramine.

"The patients in the European Scouting process do not have the same features as the patients the approved indication in the United States, but these results, in combination with other available safety data serious questions about Meridia of security for all groups of patients," said Gerald Valley Pan, MD, m.h.s., Director of the Office of the surveillance and epidemiology in CDER.

The analysis of the Agency is of the Scout movement was the subject of the FDA is Endocrinologic and metabolic Drugs Advisory Committee meeting on 15 September.

For more information:

Drug Safety: FDA recommends that communication against the continued use of Meridia (sibutramine)

http://www.fda.gov/drugs/drugsafety/ucm228746.htm

Media questions about:

Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov

Erica Jefferson, 301-796-4988; erica.jefferson@fda.hhs.gov

Consumer questions about: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

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