30 Apr 2020 Communicating emerging risks of SGLT2 inhibitors—timeliness and transparency of medicine regulators
BMJ 2020; 369:m1107 (Published 29 April 2020)
DOI: https://doi.org/10.1136/bmj.m1107
Key messages
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Sodium glucose co-transporter-2 (SGLT2) inhibitors came to market amid heightened concern over the safety of diabetes drugs
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The drugs have received several serious safety warnings since approval, but the number, timeliness, and strength of these safety communications have differed between American, Australian, Canadian, and European regulators
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One regulator identified the risk of lower limb amputation during routine pre-market assessment, but three years passed before any regulator issued a public warning
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In some instances, the wording of warnings was weakened after interactions with industry
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Greater transparency is required to assure the public of the impartiality of evidence assessment and ensure that decisions reflect public values
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