Intended for healthcare professionals

Analysis

Communicating emerging risks of SGLT2 inhibitors—timeliness and transparency of medicine regulators

BMJ 2020; 369 doi: https://doi.org/10.1136/bmj.m1107 (Published 29 April 2020) Cite this as: BMJ 2020;369:m1107

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  1. Alice Bhasale, doctoral candidate1,
  2. Barbara Mintzes, associate professor12,
  3. Ameet Sarpatwari, assistant professor of medicine3
  1. 1University of Sydney Charles Perkins Centre and School of Pharmacy, Faculty of Medicine and Health, 6W75, The Hub, Charles Perkins Centre D17, University of Sydney, NSW 2006, Australia
  2. 2School of Population and Public Health, University of British Columbia, Vancouver, Canada
  3. 3Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, USA
  1. Correspondence to: A Bhasale abha9370{at}uni.sydney.edu.au

As new risks of SGLT2 inhibitors have emerged, how have regulators responded? Alice Bhasale and colleagues compare the number, timing, strength, and transparency of public safety communications across leading medicines regulators

Key messages

  • Sodium glucose co-transporter-2 (SGLT2) inhibitors came to market amid heightened concern over the safety of diabetes drugs

  • 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

  • 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

  • In some instances, the wording of warnings was weakened after interactions with industry

  • Greater transparency is required to assure the public of the impartiality of evidence assessment and ensure that decisions reflect public values

Medicines regulators have an important role in ensuring that newly uncovered risks of approved drugs (“post-market” risks) reach prescribers and patients. Such information is conveyed through safety advisories (such as online alerts, bulletin articles, letters to health professionals) and changes to official drug prescribing information (box 1). Based on reviews of post-market safety controversies over the past two decades,1234 the public expects regulators to communicate post-market risks promptly and transparently, prioritising public over commercial interests.

Box 1

How regulators identify and communicate post-market risks

Post-market risks are identified through various means

  • Studies designed to test for specific safety outcomes, sometimes as a requirement of licensing (such as FDA post-market requirements, EMA post-authorisation safety studies).

  • Spontaneous adverse drug reaction reports collected and monitored by regulators

  • Medical literature

  • Notification or reporting by companies, as mandated by regulation

  • Other regulators

Post-market risks are communicated using:

  • Safety advisories

    • Website alerts, direct health professional communications (letters to health professionals), drug safety bulletins, and notices of safety investigations

    • Can be initiated by regulators or industry. Direct health professional communications, commonly used in the EU and Canada, are jointly …

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