Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.
On October 15, 2020, FDA warned that the use of nonsteroidal anti-inflammatory drugs (NSAIDs) around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the baby and possible complications. NSAIDs are commonly used to relieve pain and reduce fevers. They include medicines such as aspirin, ibuprofen, naproxen, diclofenac, and celecoxib. After around 20 weeks of pregnancy, the unborn babies’ kidneys produce most of the amniotic fluid, so kidney problems can lead to low levels of this fluid. Amniotic fluid provides a protective cushion and helps the unborn babies’ lungs, digestive system, and muscles develop.
For prescription NSAIDS, we are requiring changes to the prescribing information to describe the risk of kidney problems in unborn babies that result in low amniotic fluid (oligohydramnios). We recommend avoiding NSAIDs in pregnant women at 20 weeks, 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. Use of NSAIDs if deemed necessary, between 20 and 30 weeks of pregnancy should be limited to the lowest effective dose for the shortest duration. The changes to the prescribing information also indicate that health care professionals should consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours and discontinue the NSAID if oligohydramnios is found.
We will also update the Drug Facts labels of OTC NSAIDs intended for use in adults. One exception to the above recommendations is the use of the low 81 mg dose of the NSAID aspirin for certain pregnancy-related conditions at any point in pregnancy under the direction of a health care professional.
We reviewed the medical literature and cases reported to FDA for data about low amniotic fluid levels or kidney problems in unborn babies associated with NSAID use during pregnancy. Among the 35 cases reported to FDA through 2017, all were serious. Information from these cases was similar to what was found in the medical literature.
Side effects involving NSAIDs should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.
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