Together we can improve health product safety
As an ongoing commitment to openness and transparency, Health Canada is publishing summaries of its safety reviews. These summaries complement other safety related information to help Canadians make informed decisions about their medication choices. Each summary outlines what was assessed, what was found and what action was taken by Health Canada, if any.
Recent Summary Safety Reviews
- Cellex Photopheresis System and Venous Thromboembolism & Pulmonary Embolism [2019-05-03]
- Intragastric balloons - Assessing the potential risk of inflamed pancreas, developing a hole (perforation) in the esophagus and stomach, and unexpected balloon enlargement (overinflation) [2019-04-17]
- Summary Safety Review - Opsumit (macitentan) - Assessing the potential risk of liver injury [2019-03-01]
- Summary Safety Review - Gilenya (fingolimod) - Assessing the potential risk of worsening multiple sclerosis symptoms after product withdrawal (rebound effect) [2019-02-28]
- Summary Safety Review - Proscar and Propecia (finasteride) - Assessing the potential risk of suicidal thoughts and/or behaviour (suicidal ideation) [2019-02-26]
Each health product authorized for sale in Canada has terms of approval and labeling that reflects Health Canada's understanding of the benefits and harms of the product at the time of approval. Once on the Canadian market, Health Canada continues to monitor safety of health products to identify and assess potential harms. This monitoring, known as surveillance, includes the scanning of multiple sources of information (reports of adverse reactions, new safety information from foreign regulators, and medical and scientific literature) to identify potential health product-related safety issues.
You can find information on the potential safety issues that Health Canada is reviewing in the tables of New Safety Reviews.
Disclaimer: For information related to treatment options, choices of health products and their uses, illnesses, side effects or health product interactions - contact your health care professional (for example, doctor, pharmacist, etc.).
Information on health products evolves as a product goes through its life-cycle. This may start at the point of clinical trials, and then continues once the product becomes available on the Canadian market. Health Canada's understanding of the risks, benefits and uncertainties of a given health product evolves the longer that the product is used. A safety review is focused on a potential safety issue, at a specific point in time. It does not address the entire benefit-risk profile of the health product.
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