The Lancet’s new meta-analysis debunks concerns about acetaminophen during pregnancy, reaffirming its safety and contradicting previous studies.
Story Highlights
- The Lancet’s meta-analysis finds no link between acetaminophen use during pregnancy and autism or ADHD.
- Mount Sinai’s earlier research suggested potential risks, leading to FDA caution.
- Professional organizations like ACOG continue to endorse acetaminophen’s safety.
- The scientific community remains divided, affecting public health messaging.
Comprehensive Study Finds No Risk
The recent meta-analysis published in *The Lancet Obstetrics, Gynecology & Women’s Health* scrutinized approximately 60 studies and found no causal link between acetaminophen use during pregnancy and increased risk of neurodevelopmental disorders like autism spectrum disorder and ADHD. This study, using sibling-comparison methodologies, provides robust evidence, highlighting its superior design in controlling for genetic and environmental variables.
This conclusion counters earlier findings from Mount Sinai researchers, who postulated a potential association between prenatal acetaminophen exposure and these disorders. Mount Sinai’s study analyzed 46 prior studies and asserted that higher-quality research often indicated a risk, although the latest meta-analysis dismisses these concerns when acetaminophen is used as directed.
FDA’s Cautionary Stance
In September 2025, President Trump advised against Tylenol use during pregnancy, and the FDA issued a cautionary letter to clinicians. This was influenced by the Mount Sinai study, which caught public attention and stirred debate. The FDA’s guidance was intended to encourage careful consideration of acetaminophen’s use, aligning with the precautionary principle amid scientific uncertainty.
Despite the FDA’s cautious approach, organizations like the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) maintain that acetaminophen is safe when used as directed. They emphasize the importance of treating pain and fever during pregnancy to avoid risks such as neural tube defects and preterm birth.
Ongoing Debate and Implications
The scientific community is split, with Mount Sinai researchers highlighting possible biological mechanisms for the association, such as oxidative stress and hormonal disruption. Meanwhile, the Lancet’s authors insist the best-quality evidence does not support any causal link. This division has led to varied public health messages, causing confusion among pregnant women and healthcare providers.
Looking forward, the controversy underscores the need for continued research into safe pain management options for pregnant women. Regulatory agencies like the FDA may need to reassess their positions as more evidence becomes available, balancing precaution with scientific data.
Healthcare providers are urged to guide patients through this complexity, ensuring that untreated conditions don’t pose greater risks than the medications themselves.
Sources:
Acetaminophen use during pregnancy does not increase risk of autism, ADHD: Review
Using acetaminophen during pregnancy may increase children’s autism and ADHD risk
ACOG affirms the safety and benefits of acetaminophen during pregnancy
