![]() ![]() Information from these cases was similar to what was found in the medical literature. Among the 35 cases reported to FDA through 2017, all were serious. 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. ![]() 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 will also update the Drug Facts labels of OTC NSAIDs intended for use in adults. 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. 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. At around 30 weeks, NSAIDs can cause a problem that may result in heart issues in the unborn baby. We recommend avoiding NSAIDs in pregnant women at 20 weeks, rather than the 30 weeks currently described in NSAID prescribing information. Amniotic fluid provides a protective cushion and helps the unborn babies’ lungs, digestive system, and muscles develop.įor 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). 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. They include medicines such as aspirin, ibuprofen, naproxen, diclofenac, and celecoxib. NSAIDs are commonly used to relieve pain and reduce fevers. This can lead to low levels of amniotic fluid surrounding the baby and possible complications. 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. In case the water breaks prior to 37 weeks of pregnancy, antibiotics are prescribed by the doctor. ![]() When the amniotic sac suffers a tear, it gradually leaks out. In case of the water breaks, it does not always gush out. Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. The six most common reasons are: Advertisements. ![]()
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