Lose weight before a heart attack or stroke?
From weight loss pills, you can lose weight before a strokeIrina Vlasova, GZT.RU
The European Medicines Agency (EMA) last week recommended doctors not to prescribe sibutramine.
According to the agency's experts, the risk from taking the drug dramatically exceeds the positive effect.
Sibutramine (sibutramine hydrochloride monohydrate) is a medicine prescribed for obesity to suppress appetite. The active substance is sold in European countries, including in Russia ("Reduxin", "Meridia", "Lindaxa" and other trade names).
History
The drug "Meridia" was developed by the German company "Knoll AG" about 10 years ago during the search for a new antidepressant. At the stage of preclinical trials, it was found that sibutramine, acting on the centers of the brain, has the effect of reducing body weight, which turned out to be pronounced in a large number of volunteers. Nevertheless, all patients taking sibutramine note insomnia, irritability or apathy, lethargy, tachycardia, distracted attention. A few years ago, the company "Knoll AG" was bought by the company "Abbott".
Sibutramine was sentenced by the EMA Medicines Committee based on data from a clinical trial involving 10,000 obese patients. As a result, scientists concluded that sibutramine dramatically increases the risk of heart attacks and strokes in people and, accordingly, is dangerous for people with hypertension and cardiovascular diseases.
The European Medicines Agency has recommended doctors to completely abandon the prescription of drugs that include sibutramine, and pharmacies to stop selling such drugs and any marketing.
The EMA noted that sibutramine was not previously recommended for patients with identified cardiovascular diseases. Nevertheless, since the risk of cardiovascular diseases is usually high in overweight and obese patients, and also taking into account the low effectiveness of sibutramine, EMA experts consider it possible to stop using this drug completely.
In Russia, according to the industry marketing agency CMI "Pharmexpert", in 2009 sibutramine was sold for about $33 million in the form of drugs "Meridia" (produced by the American company "Abbott"), "Lindax" (produced by the Czech company "Zentiva", which joined the French group "Sanofi-Aventis") and "Reduxin" (promoted by the international marketing company "Ozone").
"In general, this is about 24.5% of the entire market of weight loss drugs," explained GZT.EN David Melik-Huseynov, General Director of CMI "Pharmexpert". – The maximum number of packages – 510 thousand – sold "Lindaks", followed by "Meridia" – 252 thousand packages, and "Reduxina" sold 148 thousand packages." The average price of the course for a month starts from 50 euros. The entire market of weight loss drugs is now about $134 million.
Last week, the U.S. Food and Drug Administration (FDA) notified American doctors about the high risk of heart attacks and stroke among patients with cardiovascular diseases taking the drug for the treatment of overweight sibutramine. Officials insist that the manufacturer should place a stricter warning in the instructions, which would clearly state that the drug should not be used by patients with cardio-vascular diseases.
Earlier, in November 2009, the department issued a message about the risks associated with the use of sibutramine, after the preliminary results of the SCOUT clinical trial were received. They showed that 11.4% of patients taking Meridia received cardiovascular complications, compared with 10% among those taking placebo. The study involved about 10,000 patients with cardiovascular diseases or type 2 diabetes mellitus with an additional cardiovascular risk factor.
After the EMA ban, the manufacturer of "Meridia" Abbot stated that it is ready to follow the recommendations of the EMA in the European Union, but will continue to promote in other territories. "When three years ago the Ministry of Health and Social Development introduced sibutramine into the lists of potent and narcotic drugs requiring prescriptions, but did not specifically stipulate restrictions on trade names, the manufacturer of Meridia continued to supply the drug for free sale," GZT said.EN Executive Director of the non-commercial partnership "Pharmacy Guild" Elena Nevolina.
"I don't think that the European ban will reduce sales in Russia, the sales field for weight loss products in Russia is large," said Sergey Shulyak, CEO of DSM.GROUP, on January 25. "Given the mentality of Russians and the high cost of the drug, companies will actively promote a specific drug and maybe even lower the price." The expert recalled that even now it is not difficult to buy sibutramine without a prescription, and regulatory authorities should pay attention to this.
In the meantime, manufacturers tell on their websites that "the drug "Meridia" is safe and well tolerated. Side effects are mild and temporary, usually do not require discontinuation of treatment," and only casually mention that "blood pressure and heart rate should be monitored when taking it." Hotlines for the promotion of sibutramine also continue to work.
Portal "Eternal youth" http://vechnayamolodost.ru26.01.2010