The European Medicines Agency (EMEA) said that it’s Committee for Medicinal Products for Human Use (CHMP) has started a review of sibutramine (Meridia) to investigate data from the SCOUT study (Sibutramine Cardiovascular OUTcome Trial) suggesting a possible increased risk of serious cardiovascular events.

SCOUT  randomized 10,742 overweight or obese patients with an increased risk of cardiovascular disease to either sibutramine or placebo. An analysis of the initial 6-week lead-in period was published in 2007 in the European Heart Journal.

Here is the relevant text from the European Medicines Agency press release:

CHMP started a review of sibutramine-containing medicines (Reductil, Zelium, Reduxade)

The Committee started a safety review of anti-obesity medicines containing sibutramine, because preliminary data suggest a possible increased risk of serious cardiovascular events. The data raising the concern come from the SCOUT study (Sibutramine Cardiovascular OUTcome Trial), which investigates long-term cardiovascular effects of sibutramine treatment in a population with high cardiovascular risk.

The review was triggered by Germany under Article 107 of Directive 2001/83/EC. As part of this procedure the CHMP will assess the impact of the new data on the benefit-risk balance of these medicines and make a recommendation whether their marketing authorisations should be maintained, changed, suspended or revoked.

A more detailed CHMP meeting report will be published shortly.