Pregnant Women Should Avoid NSAIDs After 20 Weeks
Health Canada announced on June 8, 2021, it has completed a safety review confirming that the use of non-steroid anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid (aspirin), ibuprofen, naproxen, diclofenac, and celecoxib, starting from approximately 20 weeks of pregnancy or later, may cause rare but serious kidney problems in an unborn baby.
These problems can lead to low amniotic fluid levels and possible complications, such as impaired lung maturation and loss of joint movement (limb contractures) in the newborn baby.
As a result of its findings, Health Canada advises that pregnant women not use NSAIDs from approximately 20 to 28 weeks of pregnancy unless advised to do so by their healthcare professional. The use of NSAIDs remains contraindicated (must not be used) in the last trimester of pregnancy (i.e., beyond 28 weeks to the end of pregnancy).
If a healthcare professional decides that the use of NSAIDs between 20 and 28 weeks of pregnancy is necessary, Health Canada recommends that they use the lowest effective dose for the shortest duration possible and that they consider monitoring amniotic fluid levels via ultrasound if treatment extends beyond 48 hours.
These new recommendations do not apply to the use of low-dose (81 mg) aspirin, pediatric-only formulations (i.e., those only indicated for children less than 12 years of age), or NSAIDs administered directly to the eye.
The U.S. FDA mentioned this alert in November 2020.
Health Canada confirmed it continues to monitor the situation closely and will take further action to help protect the health and safety of Canadians, if necessary. This includes continuing to work with Canadian manufacturers of NSAID products to take appropriate action in Canada in light of this new evidence. Related prescription and non-prescription NSAID product labels in Canada will be updated with this new information.