Science to Practice
Latest highlights on drug safety and efficacy

2.6.2025

Drug authorities in the EU, UK and USA have set stricter warnings concerning the use of non-steroidal anti-inflammatory drugs (NSAIDs) in pregnancy, pointing out increased risk for oligohydramnios and premature closure of ductus arteriosus with the use of NSAIDs from mid-pregnancy (gestational week 20) onwards (1).

Following these warnings and a study from the German Embryotox cohort (2), the manufacturers have updated the European summaries of product characteristics (SPCs) to include this warning as well as a contra-indication for the systemic use of these drugs during the third trimester of pregnancy. The use of NSAIDs during the third trimester may also prolong bleeding time in both mother and child, as well as lead to delayed or prolonged labor.

NSAIDs should be avoided from mid-pregnancy onwards due to increased risks for the fetus. Gravbase classification has been updated accordingly to ensure safer drug use during pregnancy.

Our recommendations in Gravbase have been updated accordingly, and the classification of these drugs has been uniformly changed to C2. Occasional use, especially during the first half of pregnancy, appears relatively safe.

For more comprehensive information, explore Gravbase and Lactbase, our specialised databases providing detailed insights on drug safety and efficacy during pregnancy and lactation.

News produced by Medbase Medical Team

References

1. FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid. 10-15-2020 FDA Drug Safety Communication.
2. Dathe, K., Frank, J., Padberg, S. et al. Fetal adverse effects following NSAID or metamizole exposure in the 2nd and 3rd trimester: an evaluation of the German Embryotox cohort. BMC Pregnancy Childbirth 22, 666 (2022) https://pubmed.ncbi.nlm.nih.gov/36028798/