FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid | FDA

FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid | FDA



FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later

The U.S. Food and Drug Administration (FDA) is warning that 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. Although this safety concern is well known among certain medical specialties, we wanted to communicate our recommendations more widely to educate other health care professionals and pregnant women. This issue affects all NSAIDs that are available by prescription and those that can be bought over-the-counter (OTC) without a prescription. For prescription NSAIDS, FDA is requiring changes to the prescribing information to describe the risk of kidney problems in unborn babies that result in low amniotic fluid. FDA is 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. If deemed necessary by a health care professional, use of NSAIDs 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. FDA will also update the Drug Facts labels of OTC NSAIDs intended for use in adults. These labels already warn to avoid using NSAIDs during the last 3 months of pregnancy because the medicines may cause problems in the unborn child or complications during delivery. The Drug Facts labels already advise pregnant and breastfeeding women to ask a health care professional before using these medicines.