The FDA issued a drug safety communication about nonsteroidal anti-inflammatory drug (NSAID) use during pregnancy, mandating that product labels include warnings about risk of a rare but serious kidney complication in infants.
Use of over-the-counter or prescription pain medications — including aspirin, ibuprofen, naproxen, diclofenac, and celecoxib — after 20 weeks of pregnancy could potentially cause fetal kidney problems resulting in low levels of amniotic fluid and pregnancy complications, the agency said.
Although current labeling for prescription medications currently advises against NSAID use after 30 weeks’ gestation due to an increased risk of fetal heart problems, the FDA stated it will expand labeling to recommend against the drug starting at 20 weeks.
The agency identified 35 reports of babies who had low amniotic fluids or kidney problems after their mothers took NSAIDs during pregnancy. This included two infants who died who had both confirmed kidney failure and low amniotic fluid levels, as well as an additional three babies who died who had kidney failure but did not have low amniotic fluids.
Eleven babies who had low amniotic fluids saw improved fluid levels after their mothers stopped taking NSAIDs. In most cases, adverse conditions in unborn babies were reversed 3 to 6 days after mothers halted medication use.
The fetus begins to produce most amniotic fluids after about 20 weeks of pregnancy. Oligohydramnios — a condition in which a fetus has low levels of amniotic fluid — may be detected after taking NSAIDs for days or weeks, but could also be noticed after just 2 days of use.
“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, said in a statement. “To this end, the agency is using its regulatory authority to inform women and their health care providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”
For prescription drugs, FDA is requiring changes to prescribing information that recommend against prescribing to pregnant people between 20 and 30 weeks’ gestation. Manufacturers of over-the-counter NSAIDs are required to make similar labeling changes for adult use.
Although aspirin is an NSAID, low-dose aspirin (81 mg) is an exception to these recommendations, as it remains an important treatment for pregnant women. FDA recommended that if a healthcare provider believes NSAID use is absolutely necessary after 20 weeks of pregnancy, they should prescribe at the lowest effective dose for the shortest duration.