[Skip to Content]
[Skip to Content Landing]
Views 1,209
Citations 0
Research Letter
April 29, 2019

Comparative Analysis of Medicines Safety Advisories Released by Australia, Canada, the United States, and the United Kingdom

Author Affiliations
  • 1Charles Perkins Centre and School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
  • 2School of Health Policy and Management, Faculty of Health, York University, Toronto, Ontario, Canada
  • 3Department of Anaesthesiology, Pharmacology, and Therapeutics, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada
JAMA Intern Med. Published online April 29, 2019. doi:10.1001/jamainternmed.2019.0294

National regulatory agencies’ decisions to approve new drugs are based on limited safety evidence collected during clinical development. Often, only when a drug enters general use do rarer or longer-term adverse events become known or better understood, prompting regulators to issue safety advisories.1 We examined how often medicines regulators in 4 countries with similar medical traditions, population health, and demographics—Australia, Canada, the United Kingdom, and the United States—were concordant in their decisions to issue safety advisories on approved prescription medicines.

Limit 200 characters
Limit 25 characters
Conflicts of Interest Disclosure

Identify all potential conflicts of interest that might be relevant to your comment.

Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.

Err on the side of full disclosure.

If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.

Not all submitted comments are published. Please see our commenting policy for details.

Limit 140 characters
Limit 3600 characters or approximately 600 words
    ×