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Benfluorex: increasing reports of valve disorders

    Prescrire International
    |May 12, 2010
    PubMed

    Insights

    Benfluorex, an amphetamine appetite suppressant, poses risks similar to fenfluramine, including heart valve issues and pulmonary hypertension. Its benefits do not outweigh these serious adverse effects, warranting market withdrawal.

    Area of Science:

    • Pharmacovigilance
    • Cardiovascular Safety
    • Drug Risk Assessment

    Background:

    • Benfluorex is an amphetamine derivative used as an appetite suppressant.
    • Concerns exist regarding its safety profile, particularly its similarity to fenfluramine.

    Purpose of the Study:

    • To evaluate the risks associated with Benfluorex use.
    • To assess the benefit-risk balance of Benfluorex in clinical practice.

    Main Methods:

    • Review of reported adverse events in France between 1998 and 2009.
    • Analysis of cardiovascular adverse effects, including pulmonary arterial hypertension and valvular heart disease.

    Main Results:

    • Approximately 30 cases of pulmonary arterial hypertension were reported.
    • A similar number of cases involving multiple heart valves were observed.
    • Adverse effects mirror those that led to the withdrawal of similar drugs.

    Conclusions:

    • The documented adverse effects of Benfluorex are severe and comparable to withdrawn amphetamine appetite suppressants.
    • There is no established clinical benefit to justify the significant risks.
    • Withdrawal from the market is recommended in the best interest of patient safety.

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