引 致 更 改 给 病 人 的 产 品 资 讯 的 药 物 不 良 反 应 警 示
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| Singapore: HSA updates on rare kidney problems in unborn babies with the use of NSAIDs in late pregnancy (English only) |
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The Health Sciences Authority (HSA) announces that it would like to update that non-steroidal anti-inflammatory drugs (NSAIDs) that are taken around 20 weeks or later in pregnancy may cause rare but serious kidney problems in the unborn baby. Additionally, as the unborn baby’s kidneys produce most of the amniotic fluid after approximately 20 weeks of pregnancy, kidney problems can result in low levels of amniotic fluid and pregnancy-related complications.
NSAIDs are commonly used for the short-term relief of pain and fever in colds and flu. They include products containing ibuprofen or naproxen which can be bought over the counter, without the need for medical supervision, in Singapore.
Currently, the patient information leaflets and package inserts of local products containing NSAIDs already caution against use during pregnancy. HSA will be working with the companies to ensure that the rare potential risk of kidney problems in unborn babies is included in the updated materials. HSA has not received any reports of low levels of amniotic fluid or kidney problems in unborn babies with the use of NSAIDs during pregnancy.
Pregnant women are advised on the following:
- Do not self-medicate with NSAIDs unless advised by your doctor.
- Consult your healthcare professional if you have questions or concerns about the NSAID medicines you are taking.
- Check the label on all medicines to see if they are suitable for use during pregnancy before taking them on your own. Consult your healthcare professional if you are unsure whether these medicines are suitable for you.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/news/nsaids_latepregnancy
In Hong Kong, there are registered pharmaceutical products containing non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen and naproxen. 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 Health Canada, and was posted on the Drug Office website on 16 Oct 2020 and 31 Oct 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/Monday, Nov 16, 2020
Issued at HKT 15:00
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