Health Canada: Mesalazine
Caution: Health Canada released a statement on 2020-09-23 indicating it has reviewed the potential risk of birth defects in babies associated with the use of mesalazine-containing products in pregnant women who were using these products to treat inflammatory bowel disease (primarily Crohn’s disease and ulcerative colitis). Health Canada conducted a safety review following international reports received from a drug manufacturer of birth defects found in babies whose mothers received mesalazine during pregnancy.
While Health Canada’s review of the available information did not confirm a link between the risk of birth defects in babies and the use of mesalazine in pregnant women, they will continue to monitor safety information involving mesalazine, which is also known as mesalamine, 5-aminosalicylic acid, and 5-ASA. If you are pregnant and are taking mesalazine, do not discontinue your medication unless advised to do so by your doctor. If you experience any side effects, please tell your gastroenterologist as soon as possible.
To learn more about the Health Canada warning on mesalazine, go to: https://hpr-rps.hres.ca/reg-content/summary-safety-review-detail.php?lang=en&linkID=SSR00247.
