The Food and Drug Administration is warning against taking nonsteroidal anti-inflammatory drugs, or NSAIDs, at 20 weeks of pregnancy or later due to the risk of rare but serious fetal kidney problems and pregnancy-related complications.
The new warning will appear on prescription and over-the-counter NSAIDs, according to an Oct. 15 FDA statement. These widely used medications, which include Advil, Motrin, Aleve, Celebrex and their generics, are taken to treat fever or pain.
The Problem With NSAIDs in Later Pregnancy
Beginning at around 20 weeks, a fetus's kidneys begin producing most of the amniotic fluid that surrounds it. Amniotic fluid cushions the fetus and aids lung, muscle and digestive system development.
Taking NSAIDs at or after this point can lead to fetal kidney problems and insufficient amounts of amniotic fluid. Low fluid levels can occur after just two days of regular NSAID use by the pregnant person or may take up to multiple weeks to develop.
However, the problem is reversible in most cases. Amniotic fluid levels typically return to normal within 3 to 6 days after a pregnant person stops taking NSAIDs, according to medical literature reviewed by the FDA.
What Should Pregnant People Do?
The FDA advises pregnant people to avoid the use of NSAIDs at 20 weeks or later unless specifically advised to do so by their health care provider.
Individuals should consider alternatives, such as acetaminophen (Tylenol) or low doses of aspirin, to treat pain and fever during pregnancy. Although aspirin is also an NSAID, the FDA warnings do not apply to small aspirin doses (81 mg).
In addition to updated labeling, the agency is also requiring new prescribing information to better advise pregnant people and their health care providers about the risks of NSAIDs in later pregnancy.
Patients who experience side effects from NSAIDs can report them through the FDA’s MedWatch program.
Current prescribing information already advises against using NSAIDs at around 30 weeks of pregnancy and later due to the potential for fetal heart problems.
Why Did the FDA Take Action?
The FDA reviewed 35 cases of low amniotic fluid levels or kidney problems related to the use of NSAIDs in later pregnancy. The cases were submitted to the FDA Adverse Event Reporting System (FAERS) database through 2017.
All of the cases were deemed “serious,” and included reports of five newborn deaths, all of whom suffered from kidney failure and two of whom had low amniotic fluid levels.