October 15, 2020
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FDA warns of possible fetal risk linked to NSAIDs

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The FDA announced that manufacturers of nonsteroidal anti-inflammatory drugs will be required to update their boxed warning to list potential fetal risk in women using the medications 20 weeks or later in their pregnancies.

The agency notified health care professionals of reports of rare, but serious, kidney problems and low amniotic fluid levels in the fetuses of women using NSAIDs in the second half of their pregnancies, which could increase the likelihood of pregnancy-related complications.

U.S. Food and Drug Administration
“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,” Patrizia Cavazzoni, MD, said. Source: Adobe Stock

“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 the FDA's Center for Drug Evaluation and Research, said in the press release. “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.”

The label change applies to both prescription and over-the-counter NSAIDs, such as ibuprofen, naproxen, diclofenac and celecoxib, which are intended to reduce pain, decrease fever, prevent blood clots and decrease inflammation. Low-dose aspirin, however, is exempt from the required label change, the FDA noted.

According to the agency, oligohydramnios — low levels of amniotic fluid — can be detected days or weeks after starting these medications, but it could be detected as early as two days after initiating regular NSAID use. The FDA noted that this condition typically resolves itself if the woman discontinues the medication.

“For prescription NSAIDs, the FDA is requiring changes to the prescribing information to describe the risk of kidney problems in unborn babies that result in low amniotic fluid and to recommend that NSAID use be limited between about 20 weeks to 30 weeks of pregnancy because of this risk,” the FDA said in the release. “Warnings to avoid taking NSAIDs after about 30 weeks of pregnancy are already included in the prescribing information because taking these medications during this time may lead to heart issues in the unborn baby.”

However, the agency said if a health care provider deems NSAID use necessary between 20 weeks to 30 weeks of pregnancy, its use should be restricted to the lowest effective dose and shortest duration. Likewise, the manufacturers of OTC NSAIDs for adult use will implement similar updates to their Drug Facts labels.