Refusal to market the Mediator in 1977 in Belgium
PARIS - The Belgian health authorities refused in 1977 to market the Mediator, used in France from 1976 to the end of 2009, according to a document published in the Tuesday edition of Le Figaro and on lefigaro.fr.
In a document that Le Figaro was able to obtain and which is dated November 24, 1977, the head of the General Inspectorate of Belgian Pharmacy announces his refusal to market the Mediator in Belgium. "I allow myself to suggest to the Minister to refuse the registration of this drug", he wrote, according to the daily.
The Belgian Medicines Commission has issued an "unfavorable opinion" to the issuance of a marketing authorization for Mediator. "In question, the insufficiency of data as for the effect (long term) of the drug", according to Le Figaro.
The Servier laboratory appealed against this decision, but in 1978, the Medicines Commission confirmed its "unfavorable opinion".
The head of the General Inspectorate of Belgian Pharmacy writes that "the new clinical data provided (...) do not allow to consider that the product has a hypolipidemic or hypoglycemic activity", still according to the daily.
Le Figaro adds that the Belgians evoke "the anorectic effect of the molecule".
The Mediator, a drug intended for overweight diabetics, also used as an appetite suppressant, was withdrawn from sale in France in late 2009. It was prescribed to some five million people in France from 1976 until its ban and would responsible for the deaths of 500 to 2.000 people.
http://www.romandie.com/infos/news2/110 ... fs240k.asp