Acetaminophen, commonly known as paracetamol, has long been considered the safest pain reliever for use during pregnancy. However, new research suggests a potential link between the drug and an increased risk of attention deficit hyperactivity disorder (ADHD) in children, raising concerns about its impact on early brain development.
In a small new study, researchers at the University of Washington monitored the bloodstream levels of acetaminophen in 307 women during their pregnancy.
They discovered that those who used acetaminophen were more than three times as likely to have children with attention-deficit/hyperactivity disorder (ADHD).
Although acetaminophen was approved decades ago, its long-term effects on fetal neurodevelopment were never thoroughly evaluated. FDA still maintains that acetaminophen poses minimal risk when used at the lowest dose required during pregnancy.
Still, lead author Brennan Baker from Seattle Children’s Research Institute believes the FDA should reconsider whether acetaminophen is safe for pregnant women.
The last time the FDA did this was in 2015, when officials concluded there was inconclusive evidence linking acetaminophen usage during pregnancy to ADHD in children.
She suggested that the FDA may need to reevaluate the drug’s safety profile in light of emerging evidence.
While the study in question has a relatively small sample size—meaning the data may not be strong enough to shift regulatory stances—agencies such as the FDA, EMA, ACOG, the Society of Obstetricians and Gynecologists of Canada, and the Society for Maternal-Fetal Medicine continue to affirm that acetaminophen poses minimal risk when used at the lowest effective dose during pregnancy.
However, researchers suggest that the findings warrant further investigation and may signal the need for regulatory agencies to reassess acetaminophen’s safety for pregnant women in the future.