The Food and Drug Administration (FDA) has announced that it is requiring labeling changes for nonsteroidal anti-inflammatory drugs (NSAIDs) to include warnings about the risk of fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment, if the drugs are used around 20 weeks gestation or later in pregnancy.
The Agency stated that the use of NSAIDs after 20 weeks of pregnancy may lead to low levels of amniotic fluid surrounding the baby resulting in kidney complications. The required labeling change recommends avoiding the use of NSAIDs in pregnant women at 20 weeks or later rather than the 30 weeks currently described in NSAID prescribing information. The recommendation, however, does not apply to low-dose aspirin (81mg) that has been prescribed for certain conditions in pregnancy. If treatment is determined to be necessary, the use of NSAIDs should be limited to the lowest effective dose and shortest duration possible, according to the FDA. Health care professionals should also consider ultrasound monitoring of amniotic fluid if NSAID treatment extends beyond 48 hours.
Oligohydramnios or neonatal renal dysfunction associated with NSAID use during pregnancy was identified in 35 cases following a search of the FDA Adverse Event Reporting System (FAERS) through 2017; neonatal death was reported in 5 of these cases. In 11 of these cases, amniotic fluid volume returned to normal after the NSAID was discontinued.
Additionally, a search of the medical literature produced 20 cases related to neonatal renal dysfunction in neonates exposed to NSAIDs in utero. Out of these cases, there were 11 deaths, 8 of which were associated with renal failure or complications from dialysis. While in most cases, oligohydramnios was observed in the third trimester, many reports have suggested even earlier onset (around 20 weeks gestation).
“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,” the FDA noted in a drug safety communication. “This issue affects all NSAIDs that are available by prescription and those that can be bought over-the-counter (OTC) without a prescription.”
For more information visit fda.gov.
FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid. [press release]. Silver Spring, MD: US Food and Drug Administration; October 15, 2020.