FDA Requires NSAID Labeling Change for Pregnant Women

The agency is requiring that labels for NSAIDs — including common anti-inflammatory pain and fever drugs like ibuprofen, naproxen, diclofenac and celecoxib — state that pregnant women who take the medication at 20 weeks or later could cause harm to their unborn child.

The FDA says NSAIDs can lead to “rare but serious kidney problems” in the fetus, potentially decreasing amniotic fluid levels and causing other pregnancy-related complications.

The label change does not apply to low-dose aspirin (81mg) because the NSAID can be an important treatment for pregnant women.