EMEA starts sibutramine review, as FDA investigates Meridia

The European Medicines Agency (EMEA) says it has started a review of sibutramine-containing anti-obesity medicines (marketed in Europe under trade names such as Reductil, Zelium, Reduxade), because preliminary data suggest a possible increased risk of serious cardiovascular events. The decision to do so came at the agency's November 16-19 meetings, which also saw decisions on a number of other drugs, reported separately today. under the heading of 'Meeting highlights.'

The data raising the concern about the anti-obesity drug come from the SCOUT study (Sibutramine Cardiovascular OUTcome Trial), which investigated 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 as to whether their marketing authorizations should be maintained, changed, suspended or revoked.

Meantime, the US Food and Drug Administration has also said it is conducting a review of sibutramine, marketed in prescription form as Meridia by drug major Abbott Laboratories, due to a recent study suggesting heart problems may be associated with the medication.

The FDA approved Meridia for weight loss in 1997. This medication is only intended for use in obese patients with certain risk factors, such as diabetes or high cholesterol, and is contraindicated in those with any history of heart problems.

'Sibutramine is approved for patients who are obese and have no history of cardiovascular disease,' stated Abbott spokesman Kurt Ebenhoch, noting that the company is reviewing the data. However, Abbott said it does not believe there is a need for a change in the safety profile of the drug when it is used in the approved patient population according to prescribing instructions.