Brussels, 20 January 2015
Dear Commissioner Andriukaitis,
On 18 December 2014, despite a negative opinion by France and Ireland, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product “Mysimba”, 8 mg / 90 mg, prolonged-release tablet, intended as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients. The decision of the Commission is now pending.
By writing to you today, I would like to urge you not to give the green light to this new medicine, mainly for two reasons:
1) by all means possible, the European Union has the duty to avoid repeating errors from the past: if we want to avoid a new Mediator scandal we should not authorize a new drug containing a molecula close to amphetamins, namely buprupion, the main active substance in “Mysimba”
2) in the US, this new drug was approved by the FDA under another name, “Contrave”, but only under the condition that a long term study is undertaken. The results will be known only by 2022. For now, you can find the following very alarming information on the website of the company itself:
“CONTRAVE can cause serious side effects of suicidal thoughts or actions. One of the ingredients in CONTRAVE is bupropion HCl. Bupropion has caused some people to have suicidal thoughts or actions or unusual changes in behavior, whether or not they are taking medicines used to treat depression. Bupropion may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. If you already have depression or other mental illnesses, taking bupropion may cause it to get worse, especially within the first few months of treatment.”
If patients commit suicide after Mysimba/Contave intake, it will be impossible to know whether it was due to the medicine, which will by definition compromise any objective and comprehensive study on the long term effects: those side effects will be uncountable.
In order to avoid a new scandal that will, once again, put EU citizens into unnecessary danger and in the end harm their confidence in the EU institutions, I count on your great sense of responsibility. Instead, the Commission should invest in obesity prevention, taking the necessary action to promote balanced diets and physical activity, but also addressing important risk factors such as endocrine disrupting chemicals and food additives.
Michèle Rivasi (MEP Greens/EFA)
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