In a communicated dated February 11, the National Medicines Safety Agency (ANSM) declares that France voted against the marketing authorization of the new anti-obesity drug Mysimba, “considering that the safety of the product was not sufficiently established. “
She therefore requested the arbitration of Brussels for a re-examination of the file of this appetite suppressant, in order to define if the risks are not greater than the benefits.
Already marketed in the United States under the name Contrave, Mysimba received on December 19, 2014 a favorable opinion for its marketing by the European Medicines Agency (EMA) for the treatment ofobesity or being overweight in adults.
Mysimba contains two combined active ingredients: naltrexone, used in the treatment of dependence (tobacco, opioids, alcohol) and bupropion, already prescribed as an antidepressant. This extended-release formulation will only be available by prescription to overweight (BMI greater than 27) or obese (BMI equal to 30) patients with at least one complication, such as diabetes, high blood pressure and cholesterol.
The EMA recommends follow-up after 16 weeks, and discontinuation of treatment if patients have not lost at least 5% of their initial weight by the end of this period.
Adverse effects to reconsider
But if France voted against, it is because uncertainties persist at the level of the neuropsychiatric risks of bupropion, and the cardiovascular risks of this appetite suppressant.
At the very beginning of January already, the independent medical journal Prescribe rebelled against such commercialization, which she said would be “a major regression for the health of patients.” “She feared a new scandal of the type” Mediator », Withdrawn from the market in 2009 in view of its cardiovascular effects. Prescribe underlined then that the health authorities had to “draw the lessons of past health catastrophes, in particular those relating to appetite suppressants banned subsequently on the European market because of serious undesirable effects. “
At the end of 2014, France and Ireland were the only two countries to vote against the opinion in favor of the marketing of Mysimba, judging the balance of benefits / risks unfavorable. The marketing review of mysimba is expected to take place in March, at the next meeting of the Standing Committee for Medicinal Products for Human Use (CHMP).
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