How do safety warnings on medicines affect prescribing?

Introduction: Many adverse effects of medicines only become known after approval, prompting regulatory agencies to issue post-market safety advisories to support safer care. Our team evaluated advisories issued by national regulators in Australia, Canada, Denmark, the United Kingdom, and the United States from 2007 to 2016 inclusive, comparing regulators' decisions to warn, effects on prescribing, doctors' awareness and responses to warnings, relevant regulatory policies, and specific case studies.

Areas Covered: Based mainly on our research program and a narrative review, this commentary describes how often regulators issue safety advisories and effects on clinical practice.

A descriptive analysis of medicines safety advisories issued by national medicines regulators in Australia, Canada, the United Kingdom and the United States - 2007 to 2016.

Purpose: To determine the frequency and characteristics of safety advisories issued by medicines regulatory agencies in Australia, Canada, United Kingdom (UK) and the United States (US).

Methods: This retrospective analysis examines medicines safety warnings issued by the US Food and Drug Administration (FDA), Health Canada (HC), the Australian Therapeutic Goods Administration (TGA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) from January 1, 2007 until December 31, 2016. A database of warnings obtained from regulators' websites was developed and warnings were classified by communication type, drug, or therapeutic class focus, and the risk discussed.

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

This study examines how often medicines regulators in Australia, Canada, the United Kingdom, and the United States were concordant in their decisions to issue safety advisories on approved prescription medicines.