At a Glance
- A major European review of 43 studies found no link between acetaminophen in pregnancy and autism, ADHD or intellectual disability
- The study covered more than 262,000 children for autism, 335,000 for ADHD and 406,000 for intellectual disability assessments
- The findings challenge recent FDA label-change discussions and comments from President Trump
Why it matters: Pregnant women and their doctors need clarity on what pain and fever medication is safe during pregnancy
A sweeping new analysis published in The Lancet Obstetrics, Gynecology & Women’s Health on January 16 delivers a clear verdict: taking acetaminophen while pregnant does not increase a child’s risk of autism, ADHD or intellectual disability. The finding directly counters recent political statements and regulatory rumblings that had cast doubt on the drug’s safety.
Seven-country review crushes long-standing fears
Researchers from seven European institutions pooled data from 43 studies deemed to have the “highest quality and most rigorous research methods.” The team compared mothers who took paracetamol-acetaminophen’s international name-during pregnancy with those who did not, creating one of the largest comparative data sets ever assembled on the question.
Key numbers from the review:
- 262,000+ children assessed for autism spectrum disorder
- 335,000+ children assessed for ADHD
- 406,000+ children assessed for intellectual disability
Lead researcher Asma Khalil, Professor of Obstetrics and Maternal Fetal Medicine at St George’s Hospital, University of London, summarized the takeaway in plain language: “The message is clear: paracetamol remains a safe option during pregnancy when taken as guided.”
Doctors applaud clarity as political storm swirls
The Lancet publication lands amid heated public debate. During a September press conference, President Donald Trump declared that “taking Tylenol is not good” and predicted the FDA would soon recommend against acetaminophen in pregnancy except when women can’t “tough it out.” The FDA subsequently announced it had “initiated the process for a label change” to reflect concerns about a possible link to neurological conditions.
Medical experts quickly pushed back. Dr. Karam Radwan, Director of the UChicago Medicine Neurodevelopmental Clinic, told News Of Los Angeles, “People have been taking Tylenol since 1960, and there’s a very long history of safety here.” Dr. Sindhu Srinivas, professor of obstetrics and gynecology at the Perelman School of Medicine at the University of Pennsylvania, echoed the sentiment, telling Today, “The science is very clear that there’s really no causal link between acetaminophen use during pregnancy and autism in children.”
Kenvue, the parent company of Tylenol, issued a statement in September defending the drug’s record: “We believe independent, sound science clearly shows that taking acetaminophen does not cause autism.” The company warned that removing the medication would leave pregnant women with “dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives.”
What the new data mean for expectant mothers
Khalil emphasized that acetaminophen is the first-line treatment doctors recommend for pain or fever during pregnancy. “They should feel reassured that they still have a safe option to relieve them of their symptoms,” she said.
Previous smaller studies had hinted at associations between acetaminophen and neurodevelopmental issues, but the new meta-analysis found those links disappear when higher-quality research methods are isolated. By filtering out weaker observational studies and focusing on those with rigorous controls, the European team produced what many clinicians view as the most definitive evidence to date.
The American College of Obstetricians and Gynecologists already supports acetaminophen as the preferred analgesic and antipyretic during all trimesters. The new data strengthen that guidance and should help physicians counsel anxious patients who have seen headlines questioning the drug’s safety.
Regulatory crossroads: will the FDA change course?
Despite the fresh evidence, the FDA has not publicly reversed its September announcement that it is reviewing label language. Any label change would undergo a months-long public-comment process, giving the agency room to incorporate the Lancet findings before finalizing new wording.
For now, pregnant women can continue to follow long-standing medical advice: use acetaminophen at the lowest effective dose for the shortest necessary duration, and consult a clinician for persistent pain or fever.
Key takeaways
- Europe’s largest-ever review found no increased risk of autism, ADHD or intellectual disability after prenatal acetaminophen exposure
- The study’s scope-covering more than a million child assessments-adds weight to existing clinical guidelines
- Health professionals urge pregnant patients to maintain trust in acetaminophen for pain and fever management
