March 2002: Sibutramine (Reductil/Meridia) Sales Banned By Italian Government

This Action Was Early Indication That Meridia Might Be An Unsafe Drug

In early March 2002, safety concerns were expressed about a prescription diet drug called Meridia (sibutramine) in the United States and in Europe.

Italy's Health Ministry suspended the sale of diet drugs containing sibutramine on March 7, 2002. Drugs containing sibutramine had only been for sale in Italy since April 2002. The 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.

About a week after the March 2002 Italian ban on sibutramine, a spokesman for Abbott Laboratories said that the company had received reports of 34 deaths in people who were taking sibutramine, with 28 in the U.S., 2 in Italy, 2 in Britain, 1 in Switzerland, and 1 in South Africa.

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.

This safety-based regulatory action concerning Meridia in Italy was referred to the European Medicines Evaluation Agency Secretariat for further assessment. Other European countries such as France, Germany, England, the Netherlands, Denmark, Portugal, Sweden, Finland and Spain issued statements informing the public of the market suspension of sibutramine. Further reviews were conducted in France, Germany and England.

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