Washington, DCThe US Food and Drug Administration (FDA) is recommending against continued prescribing and use of Meridia (sibutramine) because this drug may pose unnecessary cardiovascular risks to patients.
The FDA has requested that Abbott Laboratories—the manufacturer of Meridia—voluntarily withdraw this drug product from the United States market. Abbott has agreed to voluntarily stop marketing of Meridia in the United States.
Meridia was FDA-approved in November 1997 for weight loss and maintenance of weight loss in certain patients.
READ MORE drugs-medical-devices LEGAL NEWS
The FDA's recommendation is based on new data from the Sibutramine Cardiovascular Outcomes (SCOUT) trial
, which demonstrated a 16 percent increase in risk of major adverse cardiovascular events (a composite of non-fatal heart attack, non-fatal stroke, resuscitation after cardiac arrest and cardiovascular death) in patients treated with Meridia compared to patients taking a placebo. At the end of the 60-month trial, patients in the Meridia group lost a small amount of body weight compared to patients in the placebo group. The FDA has concluded that the risk for an adverse cardiovascular event from Meridia in the population studied outweighed any benefit from the modest weight loss observed with the drug.
In a similar move, Health Canada is informing healthcare practitioners and Canadians that Abbott Laboratories is voluntarily withdrawing Meridia from the Canadian market. Of note, Sibutramine is also authorized in Canada in generic forms. Health Canada has stated they will take appropriate action with respect to all sibutramine-containing products on the market.