Use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) beyond 20 weeks of pregnancy and risk of kidney damage in unborn babies, leading to low amniotic fluid

Starting date:
October 30, 2020
Type of communication:
Advisory
Subcategory:
Drugs, Affects children, pregnant or breast feeding women
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public
Identification number:
RA-74239

Last updated:

Summary

  • Product: Prescription and over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs)
  • Issue: Health Canada is investigating the use of NSAIDs at 20 weeks or later in pregnancy and the rare, but serious, risk of kidney problems in an unborn baby that can lead to low levels of amniotic fluid and possible complications, in response to a Drug Safety Communication recently released by the U.S. FDA on this issue.
  • What to do: While Health Canada is investigating this issue, the Department is advising pregnant women not to use NSAIDs at 20 weeks or later in pregnancy unless advised to do so by their healthcare professional.

Issue

Health Canada is investigating the use of non-steroidal anti-inflammatory drugs (NSAIDs) at 20 weeks or later in pregnancy and the rare, but serious, risk of kidney problems in an unborn baby, in response to a Drug Safety Communication recently released by the U.S. Food and Drug Administration (FDA) on this issue.

NSAIDs are commonly used to relieve pain and reduce fevers. They include medicines such as acetylsalicylic acid (aspirin), ibuprofen, naproxen, diclofenac and celecoxib.

In addition to requiring labelling changes for all NSAIDs (prescription and over-the-counter), the U.S. FDA is recommending that pregnant women avoid using prescription and over-the-counter (OTC) NSAIDs at 20 weeks or later in pregnancy and warns that kidney problems in an unborn baby can lead to low levels of amniotic fluid and possible complications. This includes impaired lung maturation and loss of joint movement (limb contractures).

In Canada, the use of prescription and OTC NSAIDs are currently contraindicated (should not be used) in the last trimester of pregnancy (week 28 to the end of the pregnancy). NSAID labels already advise pregnant women to consult with their healthcare professional before using these medicines.

While Health Canada is investigating this issue, it is recommending that pregnant women not use NSAIDs at 20 weeks or later in pregnancy, unless advised to do so by their healthcare professional.

Consistent with the U.S. FDA, Health Canada is also recommending that, if deemed necessary by a healthcare professional, use of NSAIDs between 20 and 30 weeks of pregnancy be limited to the lowest effective dose for the shortest duration and that healthcare professionals consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours. These recommendations do not apply to the use of low dose (81 mg) aspirin for specific pregnancy-related conditions under the direction of a healthcare professional, or to NSAIDs administered directly to the eye.

Health Canada is monitoring the situation closely and will take appropriate action to help protect the health and safety of Canadians. This includes working with Canadian manufacturers of NSAID products to take appropriate action in Canada in light of this new evidence.

What consumers should do

  • Do not use NSAIDs at 20 weeks or later in pregnancy unless advised to do so by your healthcare professional.
  • Consult your healthcare professional if you are pregnant and have used NSAIDs and have health concerns.
  • Report any health product side effects or complaints to Health Canada.

Related Links

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Health Canada
(613) 957-2983
hc.media.sc@canada.ca

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1-866 225-0709
hcinfo.infosc@canada.ca