FDA Expands Warning on Use of NSAIDs in Pregnancy

By Kelly Young

Edited by André Sofair, MD, MPH

The FDA is cautioning women against using nonsteroidal antiinflammatory drugs (NSAIDs) in the last half of their pregnancy.

The drugs have been associated with fetal renal dysfunction. This could lead to low levels of amniotic fluid, which can cause further complications, including limb contractures and delayed lung maturation. The FDA has received reports of 35 cases of low amniotic fluid levels or kidney problems associated with NSAID use.

The guidance applies to both prescription and over-the-counter NSAIDs. OTC labels previously warned against use in the last 3 months of pregnancy.

For prescription NSAIDs, the agency says clinicians should limit prescriptions between 20–30 weeks' gestation and avoid them entirely after 30 weeks'. If NSAIDs are necessary, their dose and duration should be limited. If treatment lasts longer than 48 hours, clinicians may consider ultrasound monitoring of amniotic fluid. If imaging reveals oligohydramnios, or low amniotic fluid volume, NSAID treatment should be stopped. Oligohydramnios has been observed as early as 48 hours after treatment initiation.

Low-dose aspirin (81 mg) is exempt from this recommendation.