Canadian health regulators have released a detailed breakdown of all adverse event reports submitted to Health Canada in 2011, providing a number of interesting insights and trends.
Health Canada said it had received 41,923 domestic adverse event reports (AERs), of which 78% were classified as "serious" adverse events. The overwhelming majority of these cases concerned pharmaceutical products (27,602) and biotechnology products (12,419). The remaining products-blood products, biologics, natural health products, radiopharmaceuticals, cells, tissues and organs-combined accounted for 1,902 of the adverse events.
Nearly a quarter of all AERs came from immunosuppressant drugs-more than the next four drug classes (psycholeptics, drugs for treatment of bone diseases, psychoanaleptics and antineoplastic agents) combined. Analgesics, antibacterials, antithrombotic agencts and agents acting on the renin-angiotensis system were all significant contributors to AERs as well.
Medical Devices and General Trends
The majority of reports originated from the marketing authorization holder (82%), while 15.4% came from consumers, patients and non-hospital-based healthcare professionals. A remaining 2.6% of cases came from hospitals.
Medical device AERs are compiled separately by Health Canada. The agency indicated it received 9,228 medical device AERs in 2011, but declined to make a similar breakdown of its data available.
The number of adverse events reported to Health Canada was up significantly over 2010-a trend consistent with past years. In 2001, the agency received just over 10,000 adverse event reports each year. As of 2006, that number had increased to nearly 15,000, and subsequently increased dramatically to nearly 20,000 in 2008 and 35,000 in 2010.
Health Canada - Canadian Adverse Reaction Newsletter, Volume 22 - Issue 3 - July 2012