Drug for the treatment of obesity Sibutramine banned in Europe
Selling the drug sibutramine, designed for weight loss, is prohibited in the European Union. As has been established, sibutramine affects the cardiovascular system and increases the risk of heart attack and stroke.
Abbott has suspended sales of the drug to treat obesity Sibutramine in Europe in connection with the recommendations of the European Committee for Medicinal Products (CHMP) on the basis of increase in cardiovascular side effects found during investigations SCOUT, which included patients at high risk of cardiovascular disease .
Committee for Endocrinology FDA has allowed to continue selling under the name Meridia sibutramine in the U.S. by prescription, ordering with instructions to make new additional drug contraindication, in connection with the investigation SCOUT. For a discussion of the risks and benefits of the drug and identify additional regulatory action on its application to a committee of experts, which will consider the full report on the study SCOUT, preparing Abbott by March 2010.
Abbott said that the SCOUT study results did not change their opinion that the drug has a positive effect in patients who are not at risk. “We believe that for a large number of patients sibutramine benefits and do not fully 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 is an inhibitor of the reuptake of norepinephrine and serotonin, as well as many sold antidepressants, although it was not developed as a drug for depression. It increases the levels of serotonin and norepinephrine in the brain, which helps patients to reduce food intake. However, the drug has shown little effectiveness in patients who are losing by an average of 4.2 kg compared to placebo.
Doubts about the impact of the drug on the cardiovascular system appeared more than ten years ago. FDA approval of the drug previously rejected because of concerns that the potential risk of high blood pressure when using sibutramine 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 in the cardiovascular system, CHMP Abbott ordered the company to conduct a study of sibutramine in patients at risk for cardiovascular disease. As a result, in 2002, Abbott began to do research SCOUT «Assessment of risk of cardiovascular disease or death in patients with obesity in the application of sibutramine.” Over 6 years in the study included 10 000 patients aged 55 years and older, obese, overweight and / or type 2 diabetes who have cardiovascular disease or predisposition to them. Patients with recent heart attack or stroke, or have congestive heart failure, were not included in the study.
Currently contraindication to the use of sibutramine in patients is the presence of cardiovascular disease, including heart attack, angina, stroke or transient ischemic attack, arrhythmia, congestive heart failure, uncontrolled hypertension.
FDA recommends that health care workers regularly measure blood pressure and heart rate in patients treated with sibutramine, and if there is sustained increase in blood pressure or heart rate, use of sibutramine should be discontinued. Also, the use of sibutramine should be discontinued in patients whose weight has not decreased by at least 5% during the first three to six months of treatment, as continued treatment is ineffective and only exposes the patient to unnecessary 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.