WASHINGTON — The Consumer Healthcare Products Association is pushing back against yesterday’s White House remarks suggesting acetaminophen use during pregnancy or infancy may be linked to autism, calling the claims “misleading” and unsupported by the weight of scientific evidence.
“The troubling claims made in today’s announcement, suggesting that acetaminophen use during pregnancy or infancy can be associated with an increased risk of autism, are misleading, lacking broad support in the scientific community, and risk harming American families and the public,” said CHPA President & CEO Scott Melville.
“As recently as last month, the U.S. Food and Drug Administration (FDA) stated that it has found no clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, or developmental outcomes. CHPA noted that the FDA has found no clear evidence that acetaminophen use during pregnancy causes adverse outcomes and cited a 2024 Journal of the American Medical Association study of nearly 2.5 million children that found no association between acetaminophen use and neurodevelopmental issues such as autism.”
“Millions of American children and pregnant women have relied on safe and effective acetaminophen for pain relief and fever reduction for more than 70 years. It is the most widely used pharmaceutical ingredient in the United States, and one of the most studied ingredients in history, with thousands of rigorous peer-reviewed studies establishing its safety profile,” Melville added.
“Importantly, acetaminophen is the only over-the-counter pain reliever considered safe for use throughout an entire pregnancy to reduce pain and fever, according to the American College of Obstetricians and Gynecologists, a view also echoed by health authorities worldwide,” Melville continued. “By suggesting links not backed by strong peer-reviewed science, announcements like today’s may discourage expectant mothers from consulting with their doctors about treating a fever, a concern made even greater when considering the limited self-treatment options available during pregnancy. The result is to expose both mother and baby to serious, well-documented health risks, including dehydration, infection progression, miscarriage, neural tube defects, congenital heart problems, and preterm birth.”
Medical organizations including the American College of Obstetricians and Gynecologists (ACOG), the Society for Maternal-Fetal Medicine (SMFM), and the Autism Science Foundation (ASF) continue to affirm acetaminophen’s safety profile when used as directed.
“Autism is a complex condition influenced by many genetic and environmental factors,” said CHPA’s Senior Vice President of Regulatory & Scientific Affairs Scott Furness, Ph.D. “It has never been attributed to any single cause, including medication exposure. As also stated by Secretary Kennedy today, ‘autism is a complex disorder with multifactorial etiology.’ Suggesting otherwise is scientifically inaccurate and harmful to public trust.”
The most recent and rigorous research on this topic does not show a causal link to autism, confirming prior studies. The 2024 study, published in the Journal of the American Medical Association (JAMA), analyzed nearly 2.5 million children using the gold-standard sibling comparison method, which controls for shared genetics and family environment, and found no association between acetaminophen use during pregnancy or infancy and neurodevelopmental issues such as autism.
This is just one reason why the leading medical and scientific authorities—including the American College of Obstetricians and Gynecologists (ACOG), the Society for Maternal-Fetal Medicine (SMFM), and the Autism Science Foundation (ASF)—all strongly agree: acetaminophen remains a safe, effective, trusted option when used as directed or in consultation with a healthcare professional.
- American College of Obstetricians and Gynecologists - "Acetaminophen remains a safe, trusted option for pain relief during pregnancy. Despite recent unfounded claims, there's no clear evidence linking prudent use to issues with fetal development."
- Autism Science Foundation - "Any association between acetaminophen and autism is based on limited, conflicting, and inconsistent science and is premature given the current science."
- Society for Maternal-Fetal Medicine - "SMFM continues to advise physicians and patients that acetaminophen is an appropriate medication to treat pain and fever during pregnancy…the weight of scientific evidence that acetaminophen use during pregnancy causes an increased risk for autism or ADHD is simply inconclusive…”
“Authors of other studies cited in today’s announcement have clearly acknowledged that their own research has not proven causation and they have urged the public to look at their research cautiously,” continued Dr. Furness.
“For example, Dr. Diddier Prada’s statement regarding his recent paper on this topic with other colleagues notes, ‘We cannot answer the question about causation – that is very important to clarify.’ And, in fact, these and other researchers continue to recommend ‘judicious acetaminophen use’ during pregnancy ‘tailored to individual risk-benefit assessments, rather than broad limitations,’ because ‘untreated maternal fever and pain pose risks’ as well.”
“Families must be aware that untreated fever and pain during pregnancy or in infancy, carry real, documented risks to both mother, unborn baby, or child,” said Melville. “Acetaminophen is well-established as safe for infants when used according to the Drug Facts Label, and it is the only pain reliever and fever reducer recognized globally by health authorities as safe for pregnant women when used in consultation with a healthcare professional. Consumers can learn more about acetaminophen from trusted resources like CHPA’s Health In Hand Foundation and its Know Your Dose Campaign which provide families with reliable education to help them make informed decisions based on sound, well-supported science.” The facts are clear: with decades of real-world use, FDA’s own safety assessments, expert consensus, and the most rigorous modern research, families can use acetaminophen with confidence.”
Kenvue, the maker of Tylenol, strongly rejected White House suggestions of a link between acetaminophen and autism, stressing that “independent, sound science clearly shows that taking acetaminophen does not cause autism.”
Bill Schiffner
