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Vasodilators: too many fatal cardiac and neurological effects with buflomedil

Offering no proven therapeutic benefits, buflomedil causes sometimes fatal adverse effects. French authorities have finally decided to withdraw it from the market.

Buflomedil, a vasodilator, has been on the market for over 20 years in France, but offers no therapeutic benefits. It causes sometimes fatal neurological and cardiac adverse effects, especially in the case of high doses or doses unsuited to renal failure.

A report from the national pharmacovigilance committee of the French Health Products Safety Agency (Afssaps) has revealed that between 2007 and 2009, several dozen cases of severe adverse effects in patients taking this drug, several of them fatal, were reported.

Buflomedil’s adverse effects, the risk situations and lack of any tangible clinical benefits were already known in 2006. Rather than withdrawing this drug from the market, the authorities decided simply to withdraw the high dosage. Consumption of this drug went down by 50% between 2006 and 2009, but clearly that was not sufficient to protect patients.

NEWS UPDATE
On 17 February 2011 the French drug agency suspended marketing authorisation for buflomedil-based products due to an unfavourable risk-benefit balance.

©Prescrire 1 April 2011

"Buflomedil: still too many fatal cardiac and neurological events" Prescrire Int 2011; 20 (115): 99. (pdf, subscribers only)
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