Tylenol maker resists label change linking pregnancy use to autism risk

Kenvue, the U.S. company behind Tylenol, formally requested the Food and Drug Administration (FDA) on Friday to reject proposed label changes for the drug. The proposal aims to avoid warnings about a possible link between acetaminophen use during pregnancy and diagnoses of autism or ADHD in children. The action takes place in Washington, U.S., following recent statements by President Donald Trump and Health Secretary Robert F. Kennedy Jr., who referenced preliminary studies on the issue.

Acetaminophen, the active ingredient in Tylenol, also known as paracetamol elsewhere, is used by over 50% of pregnant women for pain and fever relief. Experts note that alternatives like ibuprofen or aspirin carry higher risks, such as bleeding complications or heart issues for the mother and fetus.

Without the drug, untreated fever or pain can increase risks of miscarriage, birth defects, or preeclampsia, according to medical society guidelines.

The controversy gained traction in September when the government announced plans for a public health campaign and label reviews, prompted by petitions from groups like the Informed Consent Action Network.

U.S. government statements

President Trump stated in a press conference that the drug significantly increases autism risk, urging pregnant women to endure pain without it.

Kennedy Jr. echoed this, citing clinical and lab studies suggesting potential links to adverse neurodevelopmental outcomes.

The FDA sent a letter to physicians, noting an increased risk but clarifying that no causal relationship has been proven and evidence remains contradictory.

Kenvue’s stance

Kenvue argues that acetaminophen is among the most studied drugs, with decades of data confirming its safety in appropriate doses during pregnancy.

The company met with Kennedy in September to present evidence against a causal link, emphasizing that years of FDA reviews found no clear issues.

Reviewed scientific studies

A study published in August in Environmental Health reviewed 46 global studies and found strong evidence of an association between prenatal acetaminophen exposure and autism, but authors cautioned that causality was not established.

• Studies included cohorts of over 2 million children, showing relative risks between 1.2 and 1.4 for disorders like ADHD.
• However, analyses of twins or siblings eliminated the effect, pointing to maternal genetic factors as the primary cause.
• Final recommendations suggest minimal use, at the lowest effective dose under medical guidance, without broad bans.

A 2024 Swedish study with 2.48 million children confirmed that initial associations disappear in strict family controls.

The American College of Obstetricians and Gynecologists maintains that no reputable study concludes causality in any trimester.

Medical community reactions

The American College of Obstetricians and Gynecologists issued a statement reaffirming the drug’s safety for fever and pain, based on accumulated evidence.

The Society for Maternal-Fetal Medicine highlighted the dangers of untreated fever, such as preterm birth and malformations, outweighing hypothetical risks.

International bodies, like EU and Canadian agencies, issued statements confirming the pain reliever remains safe for pregnant women.

Current regulatory context

The Informed Consent Action Network’s petition, filed on the day of Trump’s conference, demands explicit warnings about neurodevelopmental disorder risks.

Kenvue calls the proposal arbitrary and unlawful, arguing it ignores the FDA’s longstanding August position, which found no clear evidence of harm.

The FDA’s acetaminophen website remains unchanged, recommending pregnant women consult healthcare professionals.

Implications for consumers

About 60% of pregnant women use the drug for over 20 days in some cases, per global estimates.

Doctors advise minimizing unnecessary exposure, prioritizing individual risk-benefit assessments.

The planned public health campaign aims to educate on alternatives, but experts urge caution to avoid unnecessary alarm.

The dispute may extend, with the FDA reviewing petitions over months, while Kenvue plans to reinforce medical consultation messaging on packaging.