Statement to Congress

Dear Colleagues,

We would like to address our concerns for recent public statements and discussions suggesting that “the use of acetaminophen during pregnancy and in pediatric patients increases the risk of neurodevelopmental disorders such as autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD).” These statements have understandably created confusion among patients and clinicians. It is crucial to clarify the current evidence, authoritative guidelines, uncertainties, and best practices moving forward.

What We Know: Safety of Acetaminophen

Long History of Use in Pediatrics and Pregnancy
Acetaminophen has been the preferred medication for pain and fever management in children and pregnant individuals for decades. When used according to guidelines (i.e., within recommended doses and for a short duration), it is generally deemed safe for both populations.

Risks of Untreated Fever or Pain
Untreated fever and pain can pose significant risks, particularly in pregnancy (e.g., fever can heighten the chances of complications, miscarriage, and birth defects); therefore, addressing these symptoms is vital to clinical care.

1. Authoritative Position Statements 
   • American College of Obstetricians and Gynecologists (ACOG): ACOG reaffirms the safety and benefits of acetaminophen during pregnancy, stating that claims linking acetaminophen to autism lack support from the comprehensive body of scientific evidence. It cautions that certain government statements may not be based on reliable data.
   • Society for Maternal-Fetal Medicine (SMFM): SMFM advises that acetaminophen is an appropriate treatment for pain and fever during pregnancy, emphasizing that existing studies suggest potential risk but do not establish causality.
   • NIH-Funded Sibling-Control Study: A 2024 study involving a large population-based sample of 2,480,797 children demonstrated, when controlling familial factors, no association between prenatal acetaminophen use and increased risk of autism, ADHD, or intellectual disability.
   • American Academy of Pediatrics (AAP): The AAP states acetaminophen is safe for children when taken as directed and finds no link to autism.

Key Facts

• Acetaminophen is commonly used to manage mild-to-moderate pain and reduce fever by altering the body’s pain response and cooling mechanisms.
• Research does not establish a causal link between acetaminophen use and autism and underscores that autism has no single, identifiable root cause.
• Parents should consult their child’s pediatrician if they have questions regarding appropriate medications.
• Available over-the-counter, acetaminophen is safe for children when dosed correctly, especially under pediatrician guidance—children under 12 weeks should not be given acetaminophen unless directed by a pediatrician.
• For children over six months with a fever, treatment with acetaminophen may be unnecessary unless they appear uncomfortable or cannot stay hydrated.
• Acetaminophen can generally be administered every 4 to 6 hours for pain or fever, with no more than 4 doses in 24 hours. Co-administration with medications containing acetaminophen should be avoided. The AAP has called for limited availability of combination medications with acetaminophen.

What Is Uncertain: Associations vs. Proven Causation

Though numerous observational studies indicate associations between prenatal acetaminophen exposure and neurodevelopmental outcomes, significant limitations exist within this research:

• • Confounding Variables: Conditions leading to acetaminophen use, such as infection, fever, and pain, may individually correlate with neurodevelopmental disorders.
  • Measurement Limitations: Challenges arise from self-reporting and recall bias, dosage variability, timing of exposure, and differences between over-the-counter versus prescription use.
  • Inconsistency in Findings: Some studies report positive associations while others show no correlation. Notably, the sibling control study mentioned earlier neutralizes shared familial/genetic factors and reveals no significant risk.

• Precautionary Public Statements: Certain government agencies have issued warnings based on associative data, but these do not equate to conclusive proof of harm.

Summary

Currently, there is no credible evidence that acetaminophen, when used appropriately, leads to neurodevelopmental disorders such as autism or ADHD. Observed associations in some studies have not been proven to be causal. More rigorous research, especially sibling-control and longitudinal studies that account for familial/genetic factors, indicates no increased risk. Leading professional societies, including ACOG and SMFM, as well as large-scale, high-quality studies, support the continued use of acetaminophen in pregnancy when clinically warranted.

Consequently, any guidance or public statements suggesting otherwise should be regarded as preliminary and unfounded, we must exercise caution to avoid causing unnecessary alarm for our lay population.

Thank you for your attention to this complex topic. 

References

1. Ahlqvist, V. H., et al. “Acetaminophen Use During Pregnancy and Children’s Risk of Autism, ADHD, and Intellectual Disability.” JAMA, 2024.
2. American Academy of Pediatrics. “Acetaminophen is Safe for Children When Taken as Directed, No Link to Autism.” AAP Fact Check
3. American College of Obstetricians and Gynecologists (ACOG). “Affirms Safety and Benefits of Acetaminophen during Pregnancy,” September 22, 2025.
4. Society for Maternal-Fetal Medicine (SMFM). “Statement on Acetaminophen Use During Pregnancy and Autism,” September 2025.
5. NIH News Release. “Study reveals no causal link between neurodevelopmental disorders and acetaminophen exposure before birth,” April 11, 2024.
6. Systematic reviews summarizing studies on prenatal acetaminophen exposure and neurodevelopmental outcomes.
7. Understanding Autism: Information for Families. HealthyChildren.org