By Sharon Atieno Onyango
There is no connection between first trimester pain reliever use and major congenital malformations, even at higher doses.
This is according to a new study published in the open-access journal PLOS Medicine which analysed 264,858 singleton Israeli pregnancies between 1998 and 2018.
The study found that 20,202 (7.6%) were exposed to Nonsteroidal anti-inflammatory drugs (NSAIDs) during the first trimester—most commonly ibuprofen (5.1%), diclofenac (1.6%), and naproxen (1.2%).
Major congenital malformations were identified from linked clinical, hospitalization, and termination records. The researchers adjusted risks for maternal and pregnancy characteristics including maternal age, ethnicity, diabetes, obesity, folic acid use, and the reason for NSAID use.
Use of NSAIDs during pregnancy was not linked to a higher risk of major birth defects overall or problems affecting organs such as the heart, brain, muscles, digestive system, or urinary system. Researchers also found no increased risk tied to specific NSAID drugs or higher doses.
“Our results provide reassuring evidence that NSAID use in early pregnancy is not associated with major birth defects,” the authors say. “These findings can help both pregnant women and physicians make informed decisions about managing pain and fever in early pregnancy.”
Dr. Sharon Daniel, Ben-Gurion University, and co-author adds, “We used data from the Southern Israeli Pregnancy Registry (SiPREG), a large pregnancy registry in southern Israel that tracks medication use and pregnancy outcomes, including birth defects identified not only at birth, but also in pregnancy terminations and during the first year of life.”
“We examined whether common pain relievers from the NSAID group, such as ibuprofen, are linked to birth defects. We found no increased risk overall or for specific types of birth defects.”
Dr. Ariel Hasidim notes, “One of the most interesting parts of this research was finding a careful way to deal with gaps in real-world data. One key issue was that some people may have used common medicines like ibuprofen without it being recorded, which could affect the results. We tackled this head-on by using a special analysis to see whether and how this missing information might have influenced our findings.”
Previous studies have raised safety concerns regarding acetaminophen while data on the safety of NSAIDs—which include widely used medications such as ibuprofen, diclofenac, and naproxen—has remained inconclusive.
