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Benfluorex (Mediator° or other brands): marketing authorisation withdrawn throughout the European Union

After years of dithering, Benfluorex’s European marketing authorisation has at long last been withdrawn, due to the drug’s serious adverse cardiovascular effects (valve damage in particular).

The European Commission decided in June 2010 that no pharmaceutical products containing benfluorex could remain on sale in the countries of the European Union.

Benfluorex is a drug of the amphetamine family, with which it shares the sometimes serious adverse effects, including allergic, neuropsychiatric and cardiovascular effects. It has been on sale for around 30 years, including in France.

In Spain, as early as 2003, the serious cardiac effects from benfluorex, similar to those observed with fenfluramine (ex-Pondéral° and other brands), and dexfenfluramine (ex-Isomeride°), led to the withdrawal from the Spanish market of all pharmaceutical products containing benfluorex, in March 2003.

©Prescrire 1 July 2010

> Click here to download the European Commission Decision regarding benfluorex (pdf, free).