FDA WARNS AGAINST USING NSAIDS IN PREGNANCY AT 20 WEEKS OR LATER

November 16, 2020

Here’s an important alert for pregnant women who are using or considering using nonsteroidal anti-inflammatory drugs (NSAIDs), a large family of prescription and over-the-counter medications commonly used to treat pain and inflammation and to reduce fever (see table below).

On Oct. 15, 2020, the Food and Drug Administration (FDA) issued a drug safety communication on its website warning that use of NSAIDs at about 20 weeks or later in pregnancy rarely may cause serious kidney problems in an unborn baby.[1]

These kidney problems can lead to oligohydramnios, a condition in which there are low levels of amniotic fluid surrounding the baby. Amniotic fluid normally provides a protective cushion and plays an important role in the development of a baby’s lungs, digestive system and muscles. Oligohydramnios in turn can lead to decreased range of motion in a baby’s arms and legs and delayed lung maturation.

List of Currently Available Oral Nonsteroidal Anti-Inflammatory Drugs

†Combination drug that contains one or more other active ingredients
*Designated as Do Not Use
**Designated as Limited Use

Although these safety concerns about the use of NSAIDs in pregnant women have been well-recognized by certain medical specialists, the FDA wanted to make sure they were more widely communicated to other health care professionals and pregnant women.

FDA findings

The FDA based its October warning on a review of the medical literature and 35 cases of oligohydramnios or impaired kidney function in newborns associated with use of NSAIDs during pregnancy that had been reported directly to the agency. The agency’s literature review revealed that oligohydramnios associated with NSAID use occurred most often during the third trimester, but multiple reports suggested an onset as early as around 20 weeks of gestation. Low amniotic fluid levels developed following NSAID use for varying amounts of time, ranging from 48 hours to multiple weeks. Importantly, the oligohydramnios in most cases resolved within 72 hours to six days following discontinuation of the NSAID. The FDA noted that in many published reports in which oligohydramnios reversed after stopping the NSAID, it recurred after use of the same NSAID resumed.

The FDA’s literature review also identified a total of 20 cases of newborns whose mothers used NSAIDs during pregnancy and who subsequently had impaired kidney function in the first days following birth. The mothers’ duration of NSAID use ranged from 2 days to 11 weeks. Although some of infants had normalization of kidney function, 11 died, including eight because of kidney failure or complications from dialysis treatment.

The FDA also conducted a search of its adverse event reporting system through July 2017 and identified 35 cases of oligohydramnios or impaired kidney function in newborns associated with maternal NSAID use during pregnancy. There were 32 cases of oligohydramnios, including eight in which the newborn had impaired kidney function. The oligohydramnios occurred as early as 20 weeks of gestation. There also were three cases of impaired kidney function in newborns without oligohydramnios having been reported. In all 11 cases of newborn kidney problems, the baby was born preterm, before 37 weeks of gestation. Five of the newborns died with kidney failure. Finally, in 11 cases of oligohydramnios, the condition completely resolved after NSAID discontinuation and recurred upon restarting the NSAID.

FDA actions

For prescription NSAIDs, the FDA is requiring revisions to the product labeling to describe the risk of kidney problems in unborn babies that can result in oligohydramnios. The labeling changes include a recommendation to avoid NSAIDs in pregnancy at 20 weeks of gestation or later. (The prior product labeling recommended against NSAID use in pregnant women at 30 weeks or later because the drugs can cause heart problems in the unborn baby.) The new product labeling for prescription NSAIDs further states that if NSAID use is deemed necessary between 20 and 30 weeks of pregnancy, it should be limited to the lowest effective dose for the shortest duration. Finally, the revised product labeling advises health care professionals to consider ultrasound monitoring for oligohydramnios if NSAID treatment continues for more than 48 hours.

The FDA also is requiring that the Drug Facts label of over-the-counter NSAIDs intended for use in adults be updated accordingly. One exception to the recommendation to avoid NSAIDs in pregnancy at 20 weeks of gestation or later is the use of low-dose (81 milligrams or less) of aspirin for certain pregnancy-related conditions at any time during pregnancy under the direction of a health care professional.

What You Can Do

If you are a pregnant woman, do not use NSAIDs at 20 weeks of gestation or later unless specifically advised to do so by your health care professional. Because many OTC medicines contain NSAIDs, you should carefully read the Drug Facts label before taking any such drug to find out if it contains an NSAID. If you are unsure if a medicine contains NSAIDs, ask your pharmacist or health care professional for help.

Acetaminophen (TYLENOL) in general is a good alternative to NSAIDs for treating pain and fever during pregnancy.

To see the FDA’s drug safety communication, visit the following link: https://www.fda.gov/media/142967/download.
 

References

[1] Food and Drug Administration. FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid. October 15, 2020. https://www.fda.gov/media/142967/download. Accessed November 13, 2020.