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Benfluorex: still on the market, despite numerous severe adverse effects

New evidence confirms that benfluorex can cause severe adverse effects. Its unfavourable risk-benefit balance justifies its withdrawal from the market.

Benfluorex, an amphetamine-based drug marketed as an adjuvant for some metabolic disorders (hypertriglyceridaemia, diabetes with obesity), has no proven benefits on morbidity and mortality. On several occasions in the past, Prescrire has signalled adverse effects, sometimes severe, associated with benfluorex: psychiatric disorders, dependence and addiction, pulmonary arterial hypertension, etc.

Updated French pharmacovigilance data on benfluorex reveals 4 new cases of neuropsychiatric adverse effects out of some 39 cases reported up to 2005. Three new cases of pulmonary arterial hypertension were added to the 17 previously observed, with no mention of exposure to any other amphetamine-like appetite-suppressing drugs.

Moreover one female patient presented damage to several heart valves, resulting in valve replacement surgery, without there being any other drug-related or other cause.

Despite the French pharmacovigilance committee’s reservations concerning benfluorex’s risk-benefit balance, this drug is still available on the French market, and patients are still exposed to unjustifiable adverse effects.

©Prescrire November 2008

Source: "Benfluorex : données défavorables en France, mais toujours pas de retrait" Rev Prescrire 2008; 28 (300): 748.

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