The FDA has issued a warning about nonsteroidal anti-inflammatory drug (NSAID) use during pregnancy, ruling that product labels must include warnings about risk of a rare but serious kidney complication in infants.
NSAIDs are over-the-counter or prescription pain medications that include aspirin, ibuprofen, naproxen, diclofenac and celecoxib. Taken by women after 20 weeks of pregnancy, these drugs potentially could cause fetal kidney problems resulting in low levels of amniotic fluid and pregnancy complications, the FDA says.
The FDA had 35 reports of babies who had low amniotic fluids or kidney problems after their mothers took NSAIDs during pregnancy, including two infants who died of kidney failure and low amniotic fluid levels, as well as an additional three babies who died of 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 three to six days after mothers halted medication 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, according to the report.
The new 20-week labeling overrides older, mandated labeling for prescription medications that advised against NSAID use after 30 weeks' gestation due to an increased risk of fetal heart problems.