其 他 安 全 警 示
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| Canada: Labelling update regarding the use of non-steroidal anti-inflammatory drugs (NSAIDs) beyond 20 weeks of pregnancy and risk of kidney damage to unborn babies (English only) |
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Health Canada announces that it has completed a safety review confirming that the use of non-steroidal 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. This can lead to low levels of amniotic fluid 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 is advising that pregnant women not use NSAIDs from approximately 20 to 28 weeks of pregnancy, unless advised to do so by their healthcare professional. Prescription and non-prescription NSAID product labels will be updated with this new information.
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 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.
Consumers are advised:
- Do not use NSAIDs starting from around 20 to 28 weeks of pregnancy, unless advised to do so by your 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).
- Consult your healthcare professional if you are pregnant and have used NSAIDs and have health concerns.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../75763a-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 (44 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, Health Canada and Singapore Health Sciences Authority, and was posted on the Drug Office website on 16 Oct 2020, 31 Oct 2020 and 16 Nov 2020. Letters to inform local healthcare professionals were issued by the DH on 16 Oct 2020. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Wednesday, Jun 9, 2021
Issued at HKT 16:00
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