US FDA is recommending against continued prescribing and use of Sibutramine because this drug may pose cardiovascular risks to patients.
FDA has requested that Abbott Laboratories—the manufacturer of Sibutramine— to voluntarily withdraw it from US market. Abbott has agreed to voluntarily stop marketing of Meridia in US.
Sibutramine was FDA-approved in 1997 for weight loss and maintenance of weight loss in patients with BMI ≥30 kg/m2 or for patients with a BMI ≥27 kg/m2 who have other cardiovascular risk factors.
FDA’s decision is based on the results of Sibutramine Cardiovascular Outcomes (SCOUT) trial, which demonstrated a 16% increase in risk of major adverse CV events (non-fatal heart attack, non-fatal stroke, resuscitation after cardiac arrest and CV death) in patients treated with Sibutramine.
FDA has concluded that the risk for an adverse CV event from Sibutramine in the population studied outweighed any benefit from the modest weight loss observed with the drug.
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