Mysimba is the name of the new anti-obesity whose marketing was authorized on December 19 by the European Medicines Agency.
This medication contains two active ingredients: naltrexone, used in the treatment of addiction dependence (tobacco, opioids, alcohol), and bupropion, prescribed as an antidepressant. This prolonged-release formulation will only be available on medical prescription, and a priori reserved for overweight or obese adults with significant health problems, such as hypertension, diabetes or cholesterol.
Orexigen Therapeutics, the maker of Mysimba, says its drug targets key circuits in the brain: the arched nucleus of the hypothalamus, linked to food intake and energy expenditure, and the reward system, controlling the pleasure of eating. . Its use, combined with sports, would allow 45% of patients to lose at least 5% of their weight.
“A major regression for the health of patients”
However, this drug is based on a principle of central nervous system control similar to other drugs, the dangerousness of which has clearly been demonstrated, such as Mediator or Sibutral. Thus, the review Prescribe, reported by the British Medical Journal, sounds the alarm, indicating that this drug constitutes “a major regression for the health of patients”.
The journal Prescrire thus denounces “the unacceptable decision of the European Medicines Agency”, which would have taken the decision to market Mysimba despite “uncertainties regarding the long-term cardiovascular effects”.
According to clinical trials on which the European Medicines Agency was based and carried out on more than 4,500 participants, the drug induces a significant weight loss of 9.3% of the initial weight, compared to taking a placebo. Mild side effects have been confirmed, such as nausea, headache, constipation, dizziness, vomiting and dry mouth.
But according to Prescribe, “A loss of weight of a few kilograms obtained by drug therapy cannot justify exposing obese or simply overweight patients to a disproportionate risk of adverse reactions, especially since the weight lost is very often regained in a few months at discontinuation of treatment ”. The review therefore calls on the European Medicines Agency to reconsider its decision, and “to learn the lessons of past health disasters, in particular those relating to appetite suppressants subsequently banned on the European market due to serious adverse effects. “.
Just like the Pick, Mysimba indeed contains an amphetamine derivative (bupriopion), a psychostimulant substance with many more or less long-term undesirable effects.
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