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FDA Requiring Labeling Changes to NSAIDs Warning of Risks in Pregnancy

Labeling must indicate risks to unborn baby with NSAID use at 20 weeks of pregnancy or later

FRIDAY, Oct. 16, 2020 (HealthDay News) -- The U.S. Food and Drug Administration is requiring labeling changes to nonsteroidal anti-inflammatory drugs (NSAIDs) that warn of the risks of taking these drugs at 20 weeks of pregnancy or later, the agency announced Thursday.

The new labeling is required to explain that if women take NSAIDs at 20 weeks or later in their pregnancy, the drugs can cause rare, serious kidney problems in the unborn baby that can lead to low amniotic fluid levels and potentially pregnancy-related complications. The recommendations apply to NSAIDs such as ibuprofen, naproxen, diclofenac, and celecoxib, but the FDA notes they do not apply to low-dose aspirin (81 mg), which may be a necessary treatment for some pregnant women.

Prescribing information for prescription NSAIDs must be updated to indicate that NSAID use be limited at 20 to 30 weeks of pregnancy. The FDA recommends that health care professionals "limit prescribing NSAIDs between 20 to 30 weeks of pregnancy and avoid prescribing them after 30 weeks of pregnancy. If NSAID treatment is determined necessary, limit use to the lowest effective dose and shortest duration possible." Similar updates will be made to the Drug Facts labels for over-the-counter NSAIDs. The agency also suggested health care professionals consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond two days.

The FDA based its decision on its own review of the medical literature and cases reported to the agency about low amniotic fluid levels or kidney problems in unborn babies related to NSAID use by pregnant women. The agency noted that oligohydramnios may be detected as soon as two days after a woman starts taking NSAIDs and the condition usually goes away if the pregnant woman stops taking the NSAID.

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