Between the authorization of a new drug, Mysimba, and the diversion of baclofen, the Drug Safety Agency (ANSM) warns about new appetite suppressant drugs
The Mediator affair obviously did not serve as a lesson. The National Medicines Safety Agency (ANSM) is warning of the appearance of a new appetite suppressant, Mysimba. It also reports the misuse of baclofen, authorized in multiple sclerosis and alcohol dependence, in slimming diets.
Since the end of December, the drug Mysimba (nalterxone / bupropion) can be marketed in Europe. The Committee for Medicinal Products for Human Use (CHMP) has given the green light in this direction. But in France, the ANSM is wary of this anti-obesity pill: “This treatment is recommended in addition to a low-calorie diet and physical activity. France voted against this opinion considering that the safety of the product was not sufficiently established and thus filed a “minority statement” “, reports the Agency on its website.
The ANSM therefore remains on its guard, and the European Medicines Agency (EMA) itself has taken several years to grant the green light. She said that the authorization given to Mysimba stems from the positive results of 4 pivotal studies. In the United States, the Food and Drug Administration (FDA) only mentions gastrointestinal or central nervous system disorders, but recognizes that “uncertainties remain regarding long-term cardiovascular outcomes. “
The diverted baclofen
Mysimba is not the only drug of concern to the ANSM. The Agency has also noted the use of baclofen to treat eating disorders, although the drug does not benefit from a prescription authorization in this specific context. Such use is strongly discouraged. “In the absence of demonstration of a benefit in these situations, and of a considerable risk of occurrence of potentially serious undesirable effects”. In the treatment of alcohol dependence, the ANSM indeed mentions side effects which can range from nausea and vomiting to suicide attempts to heart problems.
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