FDA Issues Safety Communication for NSAID Use 20 Weeks or Later in Pregnancy

The FDA has released a drug safety communication on the use of nonsteroidal anti-inflammatory drugs (NSAIDs) around 20 weeks or later in pregnancy, as use may lead to rare but serious kidney problems in an unborn baby.¹

The FDA’s safety concern aims to educate health care professionals outside medical specialties, who are aware of this concern, as well as to pregnant women, as the issue affects all NSAIDs, including those available by prescription and those that can be bought over-the-counter (OTC).¹

In its communication, the agency expressed its intention to update the Drug Facts labels of OTC NSAIDs for use in adults, which already warn against the use of NSAIDs during the last 3 months of pregnancy and advise pregnant women to consult their health care professional on the use of NSAIDs.¹

The safety concern announcement was based on medical literature review, case reports, randomized controlled studies, and observational studies. Thirty five cases of low amniotic fluid levels were reported to the FDA through 2017, all of which were serious. As for the review of medical literature, the FDA searched for cases of oligohydramnios or neonatal renal dysfunction associated with NSAID use during pregnancy and determined that most of the publications showed that oligohydramnios is mostly observed during the third trimester, but, “there are multiple reports suggesting an earlier onset, around 20 weeks of gestation.”²

A case reports and case series included 20 neonates exposed to NSAIDs in utero who experienced neonatal renal dysfunction in the first days following birth, with severity ranging from normalization at 3 days to persistent anuria requiring dialysis and/or exchange transfusion. The research also showed 11 total deaths, 8 of which were a direct consequence of renal failure or due to complications stemming from dialysis.²

The FDA recommends that health care professionals limit prescribing NSAIDs between 20 and 30 weeks of pregnancy, and after 30 weeks. If NSAIDs are deemed necessary, limit use to the lowest effective dose and shortest duration.²

An exception to the safety concern is the use of the low 81 mg dose of the NSAID aspirin at any point in pregnancy.²

The FDA urges pregnant women, patients, consumers, and health care professionals to report adverse effects from NSAIDs to the FDA MedWatch program.²

References:

1. FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid. News Release. FDA; October 16, 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.
2. 10-15-2020 FDA Drug Safety Communication. FDA. https://www.fda.gov/media/142967/download.