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NSAID Use in First Trimester Not Linked to Major Birth Defects, Study Finds

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Study Finds No Link Between Common Painkillers and Birth Defects

New research provides reassuring evidence that NSAID use in early pregnancy does not increase the risk of major congenital malformations.

Key Findings

  • A large-scale study published May 14th in PLOS Medicine analyzed 264,858 singleton pregnancies in southern Israel from 1998 to 2018.
  • 20,202 pregnancies (7.6%) were exposed to NSAIDs—including ibuprofen, diclofenac, and naproxen—during the first trimester.
  • No increased risk of major congenital malformations was observed overall (8.2% exposed vs. 7.0% unexposed; adjusted relative risk = 0.99).
  • No association was found for specific organ systems (cardiovascular, musculoskeletal, central nervous system, gastrointestinal, genitourinary) or for individual drugs.
  • Dose-response analysis showed no significant link between cumulative NSAID exposure and birth defects.

"Our results provide reassuring evidence that NSAID use in early pregnancy is not associated with major birth defects."

Background

Pain and fever are common in early pregnancy, yet treatment options have been limited due to safety concerns with acetaminophen and inconclusive data on NSAIDs. This study, using data from the Southern Israeli Pregnancy Registry (SiPREG), adjusted for key factors including maternal age, ethnicity, diabetes, obesity, folic acid use, and the underlying reason for NSAID use.

Expert Commentary

Sharon Daniel (Ben-Gurion University of the Negev and Clalit Health Services) stated: "These findings can help both pregnant women and physicians make informed decisions about managing pain and fever in early pregnancy."

Ariel Hasidim noted that the research addressed potential gaps in real-world data, such as unreported over-the-counter use, through special statistical analyses.

Source

The study was published in the open-access journal PLOS Medicine.