Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, taken during early pregnancy are not associated with an increased risk of major birth defects, according to a new study published May 14 in an open access journal. PLOS medicine Sharon Daniel of Ben-Gurion University of the Negev and Clalit Health Services in Beersheva, Israel, and colleagues.
Pain and fever are common during early pregnancy, but options for managing them are limited. Although studies have raised safety concerns about acetaminophen, data on the safety of NSAIDs, including widely used drugs such as ibuprofen, diclofenac, and naproxen, remain inconclusive.
The new study used data from the Southern Israel Pregnancy Registry (SiPREG) to analyze 264,858 singleton pregnancies from 1998 to 2018, of which 20,202 (7.6%) were exposed to NSAIDs during the first trimester, most commonly ibuprofen (5.1%), diclofenac (1.6%), and naproxen (1.2%). %). Major congenital malformations were identified from relevant clinical, hospitalization, and abortion records. The researchers adjusted risks for maternal and pregnancy characteristics, including maternal age, ethnicity, diabetes, obesity, folic acid use, and reason for NSAID use.
NSAID exposure was not associated with overall major congenital malformations (8.2% vs. 7.0% in unexposed pregnancies, adjusted relative risk = 0.99). It was also not associated with malformations in specific organ systems, such as the cardiovascular, musculoskeletal, central nervous, gastrointestinal, or urinary systems. No associations were observed for individual drugs, and dose-response analysis found no significant association between cumulative NSAID exposure and birth defect risk.
“Our results provide encouraging evidence that NSAID use during early pregnancy is not associated with major birth defects,” the authors said. “These findings will help both pregnant women and doctors make informed decisions about the management of pain and fever during early pregnancy.”
We used data from SiPREG, a large pregnancy registry in southern Israel that tracks drug use and pregnancy outcomes, including birth defects identified not only at birth but also at the time of abortion and during the first year of life. ”
Sharon Daniel, Senior Clinical Lecturer, Ben-Gurion University of the Negev
Daniel added: “We looked at whether common painkillers from the NSAID group, such as ibuprofen, were associated with birth defects. We found no increased risk for overall or specific types of birth defects.”
Dr. Ariel Hasidim said, “One of the most interesting aspects of this study is that it found a way to carefully address gaps in real-world data. One key issue is the possibility that some people may have used common drugs such as ibuprofen without being recorded, and the consequences We tackled this issue head-on using special analysis to see if and how this missing information affected our findings.”
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Reference magazines:
Hasidim, AA, others (2026) Exposure to nonsteroidal anti-inflammatory drugs during the first trimester and risk of major congenital malformations: A retrospective registry-based cohort study. PLOS medicine. DOI:10.1371/journal.pmed.1005063. https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1005063.
