Slimming drugs stopped
According to a recommendation of the European Medicines Agency: pharmaceutical manufacturers will stop the marketing of the "slimming" drugs of anti-obesity with the active ingredient sibutramine
Long-term use may even increase the risk of cardiovascular disease
The drug master stopped the marketing of anti-obesity drugs with the active ingredient sibutramine in the European Union, Iceland and Norway. Thus, the drug will no longer be available on the German market. The impetus for this decision was apparently the recommendation of the European Medicines Agency (EMA), which wants to "let the authorization of anti-obesity with the active ingredient sibutramine".
Sibutramine-containing medicines were first approved in 1999 for the treatment of diet-related obesity as part of a comprehensive weight-loss program. These include u. a. a change in eating habits and expansion of physical activity.
According to the Federal Institute for Drugs and Medical Devices, a long-term study has shown that no significant weight reduction takes place in the patients. In addition, it could not be proven that the drug reduces the risk of cardiovascular diseases, according to the Federal Institute. It is expected to increase the risk of cardiovascular disease even after long-term use. The Scientific Committee for Medicinal Products for Human Use (CHMP) stated: "The results of this study indicate that for overweight patients with additional risk factors, taking sibutramine is associated with an increased risk of serious cardiovascular events such as heart attack or stroke is. "
The pharmaceutical company had the active ingredient sibutramine Europe-wide under the brand names Reductil, Meridia, Sibutral, Ectiva and Raductil distributed in pharmacies. Outside the European Union, however, the active ingredient sibutramine will continue to be available, say the pharmaceutical companies. You do not want to take the drug from the US market. „The product remains in the US in the market“, informed the manufacturer. The manufacturer assumes a positive "benefit-risk profile" and does not share the opinion of the Committee and the recommendation to suspend the medicinal product.
Patients taking the medicine should contact their family doctor to discuss further treatment. However, patients do not incur any damage in case of an unauthorized discontinuation of the drug, said a spokesman for the Federal Institute for Drugs. The pharmacies will receive so-called "Rote-Hand-Briefe" in the next few weeks. In it, the Apothcs are informed about the decision. (sb, 22.01.2010)
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