Meridia/Sibutramine Sales Were Suspended In Europe For Several Months During 2002

Action Taken By Italy's Health Safety Ministry Was Reversed Quickly By European Drug Agency

On March 7, 2002, Italy's Health Ministry suspended the sale of weight-loss products containing sibutramine, the active ingredient for Meridia. Sibutramine is sold as Reductil, Reduxade, and Ectiva in Europe. The drug had only been for sale in Italy since April 2001. This decision was based on 50 reports of serious adverse events, including 2 cardiovascular deaths, during treatment with sibutramine-based drugs. Regulators in France and the United Kingdom were said to be reviewing the safety of weight-loss drugs containing sibutramine at that time, also.

In late June 2002 Europe's Committee for Proprietary Medicinal Products (CPMP) concluded that the obesity drug sibutramine had a favorable risk/benefit profile; however, the CPMP requested that a letter be sent by Abbott Laboratories to physicians in Europe explaining and reinforcing appropriate use of their sibutramine products, Reductil, Reduxade, and Ectiva. Furthermore, the European drugs agency said its scientific committee would keep the diet drugs Reductil, Reduxade, and Ectiva -- also known as Meridia -- under review, and would follow up a sibutramine safety and efficacy trial it asked Abbott to do in 2002.

Thereafter, Abbott worked with the Italian government to return its sibutramine products to market.

In Europe sibutramine is sold by Abbott as Reductil.  This diet drug is also sold by Abbott together with its co-marketing partners GlaxoSmithKline and Bracco under the names Reduxade and Ectiva in Europe.

Update: In January 2010, at the request of European drug regulators, Abbott agreed to suspend sales of its sibutramine products in Europe.

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