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Sibutramine is banned in Europe

Sales of the drug sibutramine, designed as weight loss medicine, is prohibited in all countries of the European Union. It was found that sibutramine negative effect on the cardiovascular system and increases risk of heart attack and stroke.

Abbott stopped selling the drug for the treatment of obesity Sibutramine in Europe in connection with the recommendations of the European Committee for Medicinal Products (CHMP) on the basis of increased cardiovascular side effects identified in the research process SCOUT, which included patients at high risk of cardiovascular disease .

Committee on Endocrinology and Metabolism FDA still allowed to continue selling sibutramine called Meridia in the U.S. by prescription, thus obliging the user to make a new drug for an additional contraindication, in connection with the investigation SCOUT. To discuss the relationship of risks and benefits of the drug and identify additional regulatory action on its application to a committee of experts to consider a full report on the study SCOUT, being prepared by Abbott by March 2010.

Abbott reported that the study results SCOUT did not change their opinion that the drug has a positive effect in patients not at risk. "We believe that for a large number of patients sibutramine benefits and not entirely agree with the committee's recommendation and suspend sales of the drug. However, we will act exactly as recommended by the committee", said Eugene Sun, vice president, Global Pharmaceutical R & D.

Sibutramine is sold in Europe since 1999 under the brand names: Reductil, Reduxade and Zelium, etc. The drug inhibits the reuptake of norepinephrine and serotonin, as well as many selling antidepressants medication, although it has not been developed as a drug for depression. It increases levels of serotonin and norepinephrine in the brain that helps patients reduce the amount of food consumed. However, the drug showed little efficacy in patients who are losing an average of 2-4 kg compared with placebo.

Doubts about the drug on the cardiovascular system appeared more than ten years ago. FDA previously rejected approval of the drug because of concerns that the potential risk of high blood pressure when using sibutramine more than its effect on weight loss. Nevertheless, FDA approved the drug, including warnings about the use of sibutramine in patients with cardiovascular diseases.

Following doubts about the safety of sibutramine on the cardiovascular system, CHMP ordered Abbott to conduct a study of sibutramine in patients at high risk of cardiovascular disease. As a result, in 2002, Abbott began to conduct research SCOUT Ā«Evaluation of the risk of cardiovascular disease or death in patients with obesity in the application of sibutramine. For 6 years in the study included nearly 10,000 patients aged 55 years and older, obese, overweight and / or type 2 diabetes who have cardiovascular disease or predisposition to them. Patients who have recently undergone a heart attack or stroke, or have congestive heart failure, were not included in the study.

At present a contraindication to the use of sibutramine is the presence in patients of cardiovascular diseases, including heart attack, angina, stroke or transient ischemic attack, arrhythmia, congestive heart failure, uncontrolled hypertension.

FDA recommends that health workers routinely measure blood pressure and heart rate in patients treated with sibutramine, and, if a steady rise in blood pressure or heart palpitations, the use of sibutramine should be discontinued. Also, the use of sibutramine should be discontinued in patients whose weight has not dropped at least 5% during the first three to six months of starting treatment, because continued treatment is ineffective and only exposes the patient to undue risk. EMEA recommends that doctors not to prescribe a drug sibutramine, pharmacists do not let him go, and patients seek emergency medical attention for a change of therapy.

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