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Adequacy of clinical trial evidence of metformin fixed-dose combinations for the treatment of type 2 diabetes mellitus in India
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  • Published on:
    How to ensure safety of medications without spreading hysteria
    • Farah N Khan, Endocrinology Fellow Emory University School of Medicine

    The information conveyed by Valerie Evans, Peter Roderick, and Allyson Pollock is compelling and of serious concern. While I agree that the explosion of brand-name fixed dose combination (FDC) medications in the Indian market is not safe or rational, I worry that the presentation of the information in this analysis may create some hysteria based on some of the lay media coverage of this study. It is unfortunate that there is such little clinical evidence on the safety and efficacy of the most commonly used Metformin FDCs that are sold to treat type 2 diabetes in India, but is irresponsible to publish such an article without some discussion of the potential harms that could come from abruptly stopping the Metformin FDCs .

    I agree that “the convenience of FDCs should not trump efficacy” - but there is already significant distrust in Western medicine by many patients in India without further added hysteria. The authors of this study bring to light the importance of tighter regulation and improved standards for the pharmaceutical industry in India, but the paper would have been better with a more evenhanded presentation of the information. Efficacy data on the Metformin FDCs may be limited, but there is no telling the degree of hyperglycemic crises that may emerge if many patients stop all their medications on the basis of lay media coverage of this analysis without first consulting with their prescribing physicians.

    Conflict of Interest:
    None declared.