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--- Reductil (Sibutramine) Withdrawn --- PDF Print Email


Abbott Laboratories' medication, Reductil (Sibutramine), taken by approximately 86,000 people in the UK last year, should no longer be prescribed, nor should pharmacists fill any further prescriptions. Patients on Reductil should seek immediate review with their doctor. Patients may stop treatment before their appointment if they wish.

Based on the results of a major study involving 9,800 overweight or obese patients, aged 55 years or older and at high risk of cardiovascular events treated with sibutramine for up to six years, the European Medicines Agency and the Committee for Medicinal Products for Human Use (CHMP) concluded that the risk/benefit profile of Reductil no longer remained favourable.

The Sibutramine Cardiovascular OUTcomes (SCOUT) study was conducted as a post approval commitment to the CHMP to evaluate the cardiovascular safety of long-term sibutramine use. Patients treated with sibutramine experienced a 16 per cent increased risk of non-fatal myocardial infarction, non-fatal stroke, resuscitated cardiac arrest, or cardiovascular death compared with placebo-treated patients. This result was driven by an increased incidence of non-fatal myocardial infarction and stroke.