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| The United Kingdom: Non-steroidal anti-inflammatory drugs (NSAIDs): potential risks following prolonged use after 20 weeks of pregnancy (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces to remind healthcare professionals that use of systemic (oral and injectable) NSAIDs such as ibuprofen, naproxen, and diclofenac is contraindicated in the last trimester of pregnancy (after 28 weeks of pregnancy).
A review of data from a 2022 study has identified that prolonged use of NSAIDs from week 20 of pregnancy onwards may be associated with an increased risk of oligohydramnios (low levels of amniotic fluid surrounding the baby) and fetal renal dysfunction. Some cases of constriction of the ductus arteriosus (narrowing of a connecting blood vessel in the baby’s heart) have also been identified at this early stage.
If, following consultation between the patient and a healthcare professional, use of a systemic NSAID after week 20 of pregnancy is considered necessary, it should be prescribed for the lowest dose for the shortest time and additional neonatal monitoring considered if used for longer than several days. This is in addition to giving advice to discontinue use of any NSAID in the last trimester of pregnancy.
Healthcare professionals are advised:
- systemic (oral and injectable) NSAIDs are contraindicated during the last trimester (after 28 weeks) of pregnancy due to the risk of premature closure of the ductus arteriosus and renal dysfunction in the fetus and due to prolongation of maternal bleeding time and inhibition of uterine contractions during labour;
- a review of data from a 2022 study has identified that prolonged use of NSAIDs from week 20 of pregnancy onwards may be associated with an increased risk of: (a) oligohydramnios resulting from fetal renal dysfunction; this may occur shortly after initiation, although it is usually reversible upon discontinuation; and (b) cases of constriction of the ductus arteriosus, most of which resolved after treatment cessation;
- avoid prescribing systemic NSAIDs from week 20 of pregnancy unless clinically required and prescribe the lowest dose for the shortest time in these circumstances;
- antenatal monitoring for oligohydramnios should be considered if the mother has been exposed to NSAIDs for several days after week 20 of pregnancy; the NSAID should be discontinued if oligohydramnios is found or if the NSAID is no longer considered to be clinically necessary
- to instruct patients who are pregnant to avoid use of NSAIDs available without prescription from week 20 of pregnancy onwards unless advised by their healthcare professional
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/non-steroidal-anti-inflammatory-drugs-nsaids-potential-risks-following-prolonged-use-after-20-weeks-of-pregnancy
In Hong Kong, there are registered pharmaceutical products containing non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen and diclofenac. So far, the Department of Health (DH) has received adverse drug reaction related to ibuprofen (4 cases), naproxen (3 cases) and diclofenac (19 cases), but these cases are not related to oligohydramnios, fetal renal dysfunction or constriction of the ductus arteriosus. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 16 Oct 2020, with the latest update posted on 9 Jun 2021. Letters to inform local healthcare professionals were issued by the DH on 16 Oct 2020. In Feb 2022, the Registration Committee of the Pharmacy and Poisons Board (the Committee) discussed the matter on the warnings related to the risk of oligohydramnios, fetal renal dysfunction and constriction of the ductus arteriosus when used in pregnancy; and decided that the sales pack or package insert of the above products should include the relevant safety information. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/ Wednesday, June 28, 2023
Issued at HKT 18:45
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