FDA Warns Against NSAID Use During Second Half of Pregnancy
The US Food and Drug Administration (FDA) has released a new drug safety communication recommending that nonsteroidal anti-inflammatory drugs (NSAIDs) be avoided at approximately 20 weeks’ gestation or later in pregnancy.
According to the FDA, the use of NSAIDs during the second half of pregnancy puts the fetus at risk for fetal renal dysfunction that can lead to oligohydramnios and, in some cases, neonatal renal impairment. The FDA is now requiring that these risks be included on the prescribing information for prescription NSAIDs.
“We are recommending avoiding NSAIDs in pregnant women at 20 weeks or later in pregnancy rather than the 30 weeks currently described in NSAID prescribing information. At around 30 weeks, NSAIDs can cause a problem that may result in heart issues in the unborn baby,” the FDA reported.
If a health care professional deems that the use of NSAIDs between 20 and 30 weeks of pregnancy is necessary, the FDA recommends that the use be limited to the lowest effective dose for the shortest duration. However, at 30 weeks of pregnancy and later in pregnancy, the prescribing of NSAIDs should be avoided.
As an additional revision, the prescribing information will also indicate that health care professionals should consider monitoring amniotic fluid via ultrasonography if NSAID treatment lasts longer than 48 hours.
The recommendations pertain to both prescription and over-the-counter NSAIDs; the exceptions are low-dose aspirin, 81 mg, prescribed for certain conditions in pregnancy and NSAIDs administered directly to the eye.
The drug safety communication comes after the FDA received 35 cases—all serious—of low amniotic fluid levels or kidney problems associated with NSAID use during pregnancy through 2017.
FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid. Drug safety communication. US Food and Drug Administration. October 15, 2020. Accessed October 19, 2020. https://www.fda.gov/drugs/drug-safety-and-availability/fda-recommends-avoiding-use-nsaids-pregnancy-20-weeks-or-later-because-they-can-result-low-amniotic