European Medicines Agency responds to criticism of staff member

News 14/07/2011

The European Medicines Agency has responded to a letter from a French member of parliament criticising the conduct of an Agency staff member.

The letter from Mr Gérard Bapt to European Union Commissioner John Dalli claims that Dr Xavier Kurz, currently working in the Agency's Pharmacovigilance and Risk Management Sector, minimised and contested a safety signal when he drafted a report on aortic valve deficiencies in patients taking anorectic agents such as fenfluramines in 1994, while working for the Belgian Center of Pharmacovigilance.

The PDF iconletter from the Agency to Mr Bapt clarifies key facts and describes Dr Kurz's important role in highlighting the risk associated with fenfluramines, which is now considered to be a key element in the first European review of the benefit-risk balance of anorectic agents. A subsequent European Commission decision of 9 December 1996 on this review can be linked directly to the issues raised in the study co-authored by Dr Kurz.

Dr Kurz has worked at the Agency as a pharmacovigilance expert since 1 September 2005.

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