Other safety alerts
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| Canada: 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 |
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Health Canada announces that it 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 US 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 FDA is recommending that pregnant women avoid using prescription and over-the-counter 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 over-the-counter 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 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.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../74239a-eng.php
In Hong Kong, there are registered pharmaceutical products containing non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, naproxen, diclofenac and celecoxib. So far, the Department of Health (DH) has received adverse drug reaction related to aspirin (49 cases) and other NSAIDs (38 cases), but these cases are not related to low levels of amniotic fluid. Related news was previously issued by the United States Food and Drug Administration, and was posted on the Drug Office website on 16 Oct 2020. Letters to inform local healthcare professionals were issued by the DH on the same date. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Saturday, Oct 31, 2020
Issued at HKT 13:00
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