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.

Pharmacoepidemiology and Drug Safety
Lucy T PerryBarbara Mintzes

Abstract

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). 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. Advisories identifying the same drug or therapeutic class and risk were combined into groups termed "drug-risk issues" for comparisons between regulators. Over this 10-year period, 1441 advisories were identified, with the MHRA issuing the most advisories (MHRA = 469, FDA = 382, HC = 370 TGA = 220). Seventy two percent focussed on single drugs (1034/1441) and 58.7% were alerts (846/1441) posted on the regulators' websites. Diabetes drugs, smoking cessation drugs and immunomodulatory agents were the individual drug types most often subject to safety advisories, while antidepr...Continue Reading

References

Sep 19, 2006·Pharmacoepidemiology and Drug Safety·Ceri HirstElizabeth Andrews
Oct 23, 2008·JAMA : the Journal of the American Medical Association·Thijs J GiezenAntoine C G Egberts
Jan 20, 2010·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Harald E HeemstraHubert G M Leufkens
Jul 20, 2010·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Sten OlssonMary Couper
Aug 10, 2011·Clinical Toxicology : the Official Journal of the American Academy of Clinical Toxicology and European Association of Poisons Centres and Clinical Toxicologists·Nick A Buckley, Simone Rossi
Apr 7, 2012·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Sigrid PieningPeter G M Mol
Aug 7, 2013·BMC Health Services Research·Janet G BasemanJeffrey Duchin
Mar 21, 2015·Arteriosclerosis, Thrombosis, and Vascular Biology·Calvin H YehJeffrey I Weitz
Mar 2, 2017·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Aaron S KesselheimEric G Campbell
Nov 28, 2018·Annual Review of Medicine·Alexander C Fanaroff, E Magnus Ohman
Mar 7, 2019·Pharmacoepidemiology and Drug Safety·Marc TorkaJoel Lexchin
Jun 4, 2019·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Jessica T DeFrankOlivia Burrus
May 1, 2020·BMJ : British Medical Journal·Alice BhasaleAmeet Sarpatwari

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Citations

Nov 11, 2020·Pharmacology Research & Perspectives·Ashleigh HooimeyerBarbara Mintzes
Jul 20, 2021·Internal Medicine Journal·John McEwen, Ian W Boyd
Aug 3, 2021·British Journal of Clinical Pharmacology·Alice L BhasaleBarbara J Mintzes

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