HSA Updates on Rare Kidney Problems in Unborn Babies with the Use of NSAIDs in Late Pregnancy

The Health Sciences Authority 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.

2        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. Please see Annex A of the pdf version for the list of oral NSAIDs sold over the counter in Singapore.

3        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.

Consumer advisory

4        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.

5        This safety update follows HSA’s assessment of safety information communicated by the United States Food and Drug Administration (FDA) in October 2020[1].

HEALTH SCIENCES AUTHORITY
SINGAPORE
13 NOVEMBER 2020

Published: 13 Nov 2020

HSA Updates