Sibutramine suspension sets new standard

By suspending the licence for sibutramine (Reductil), the European Medicines Agency has established a high standard for the balance of efficacy and safety for weight-loss drugs.

    The decision was made after an interim analysis of the six-year SCOUT study, a trial in 9800 overweight and obese patients at high cardio­vascular risk, revealed an excess of cardiovascular deaths with sibutramine compared with placebo (11.4 vs 10 per cent). The excess risk was confined to patients with a history of cardiovascular disease.
    Even though such patients are not normally eligible for sibutramine treatment, the EMEA says that being overweight or obese means an individual is at increased cardiovascular risk and sibutramine would therefore pose an additional risk (www.ema.europa.eu). Because the weight loss achievable with sibutramine is modest (2-4kg) and temporary, its benefit does not outweigh the additional risk of cardiovascular events.
    • The MHRA (www.mhra.gov.uk) has warned that counterfeit orlistat OTC (Alli) bought over the internet has been found to contain sibutramine. The counterfeit capsules contain powder, not white pellets, and are supplied in packs of 120 whereas the genuine product is supplied in packs of 42 and 84.