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Doctors notified over suspension of Reductil

Abbott Laboratories Ireland has issued an important safety information notice to doctors on the suspension of marketing authorisations for sibutramine (Reductil), due to increased cardiovascular risk observed in the SCOUT trial.

The notice from Abbott’s Medical Director Dr Michelle Costello-Smith advised prescribers that they should not issue any further prescriptions for the weight-loss medication, and should review the treatment of patients currently taking the obesity drug.

Based on the results of the Sibutramine Cardiovascular OUTcomes (SCOUT) study, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the risk/benefit profile of Reductil no longer remained favourable.

SCOUT was a randomised, double blind, placebo-controlled study, with a six-week lead-in period during which all participants received sibutramine. The study was conducted as a post approval commitment to the CHMP to evaluate the cardiovascular safety of long-term sibutramine use.

The study included about 9,800 overweight or obese patients, aged 55 years or older, at high risk of cardiovascular events. In the study, these high-risk cardiovascular patients were treated with sibutramine for up to six years.

Patients treated with sibutramine experienced a 16 per cent increased risk of a primary outcome event of non-fatal myocardial infarction, non-fatal stroke, resuscitated cardiac arrest, or cardiovascular death (561/4906, 11.4 per cent) compared with placebo-treated patients (490/4898, 10.0%) (hazard ratio 1.161 [95 per cent CI 1.029, 1.311]; p=0.016). This result was driven by an increased incidence of non-fatal myocardial infarction and stroke.

In the message posted online yesterday (January 26, 2010) by the Irish Medicines Board (IMB), Dr Costello-Smith added that any suspected adverse reaction following the use of sibutramine containing medicinal products should be reported to her company’s medical department and/or the IMB, in the usual way.

For further information visit www.imb.ie.

Posted in Regulation on 27 January 2010
Tags: IMB, obesity