The Food and Drug Administration (FDA) is recommending that pregnant women avoid using over-the-counter and prescription drugs containing nonsteroidal anti-inflammatory drugs (NSAIDs) around 20 weeks of gestation or later. NSAIDs may cause rare but serious kidney problems in the fetus and can lead to oligohydramnios.
The warning does not apply to use of 81 milligram (low dose) aspirin at any point in pregnancy under the direction of a health care professional or NSAIDs administered directly to the eye.
If health care providers deem treatment with NSAIDs necessary between 20 and 30 weeks of pregnancy, the FDA recommends using the lowest effective dose for the shortest duration. Health care providers also are urged to consider monitoring amniotic fluid via ultrasound if treatment with NSAIDs lasts longer than 48 hours.
Medical literature reviewed by the FDA showed oligohydramnios was reversible within 72 hours to six days following discontinuation of the NSAID in most cases. The FDA also reviewed several case reports and series in which neonates exposed to NSAIDs in utero experienced neonatal renal dysfunction in the days following birth.
Prescribing NSAIDs at 30 weeks and later is not recommended because of the additional risk of premature closure of the fetal ductus arteriosus.
Find details about the NSAID warning and how to report suspected adverse events to FDA MedWatch at https://bit.ly/FDAsafety10-16-20.