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Editorial
Do regulatory safety warnings on medicines miss the mark?
  1. Barbara Mintzes12
  1. 1 School of Pharmacy and Charles Perkins Centre, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales, Australia
  2. 2 The University of British Columbia School of Population and Public Health, Vancouver, British Columbia, Canada
  1. Correspondence to Dr Barbara Mintzes, School of Pharmacy and Charles Perkins Centre, The University of Sydney Faculty of Medicine and Health, Sydney, New South Wales 2006, Australia; barbara.mintzes{at}sydney.edu.au

https://doi.org/10.1136/dtb.2023.000053

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    Knowledge of the harmful effects of medicines is limited at the point at which market authorisation is granted, with safety data based on a median of 1044 patients exposed in premarket studies of drugs licensed in the USA from 2002 to 2014.1 Patients with serious comorbidities, polypharmacy and older people are often excluded, and evidence of infrequent or longer-term harm only emerges postapproval. Regulatory safety advisories, including ‘dear health professional communications’, and safety alerts issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and other regulators are often the first warnings of longer-term or rare serious harm. Recent examples from the MHRA include a notification that atrial fibrillation has been added to the safety information of medicines containing omega-3 acid ethyl esters that are licensed for the treatment …

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    Footnotes

    • Competing interests None declared. Refer to the online supplementary files to view the ICMJE form(s).

    • Provenance and peer review Commissioned; externally peer reviewed.