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Europe…cautious approval of an American drug against obesity

An anti-obesity drug produced by American laboratories, Orexigen Therapeutics, has received the green light to be marketed in Europe, according to what the European Medicines Agency (EMA) revealed.

 

The agency’s Committee for Human Medicines (CHMP) recommended stopping the release of Mezimba (known in the United States as Contrave) on the market.

 

This medication is based on a combination of two main agents: naltrexone, which is used to treat alcohol and opioid addiction, and buproprion, which is used as an antidepressant, which also helps to stop smoking.

 

After several years of hesitation due to the risk of heart attacks, the United States Food and Drug Administration approved its marketing last September.

 

The European Medicines Agency explained in its statement that the drug “Mizimba” will only be available based on a prescription, and is intended for adults who suffer from obesity or overweight, and also face high blood pressure or cholesterol levels.

 

The agency stated that among the possible side effects of this drug are problems in the stomach, intestines, and central nervous system, noting that the long-term effects on the heart and blood vessels are not yet certain.

 

The agency added that the average results of a clinical test are “reassuring regarding the possibility of developing serious cardiovascular diseases.”

 

Patients who are prescribed Mezimba should see their doctors after 16 weeks and stop treatment if they do not lose 5% of their weight, according to the EMA.

 

The European Commission still has to give its official approval before starting to market the drug in member countries of the Union

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