Trump Administration’s Claims on Acetaminophen and Autism Spark Scientific Debate

Acetaminophen During Pregnancy: Research, Risks, and Realities

On September 22, 2025, the Trump administration, represented by President Donald J. Trump and Health Secretary Robert F. Kennedy Jr., announced new guidance and policy shifts regarding acetaminophen use during pregnancy, arguing that there is evidence linking it to an increased risk of autism spectrum disorder (ASD) and ADHD in children.

This announcement also included plans to:

• Initiate label changes on acetaminophen products to reflect possible neurological risks.
  
  
• Issue a “Notice to Physicians” urging caution and more judicious prescribing or advising of acetaminophen usage in pregnancy.
  
  
• Promote research into leucovorin (a form of folinic acid) as a potential treatment for some symptoms associated with autism.
  

The statements have stirred immediate responses from medical associations, scientific researchers, pharmaceutical companies, and public health agencies.

What the Research Actually Says (So Far)
Evidence Suggesting Association

• Several observational studies (cohort, population-based) over recent years have reported associations between frequent or prolonged prenatal acetaminophen use and higher rates of neurodevelopmental disorders in children — notably autism and ADHD.
  
  
• Harvard researchers reported that acetaminophen during pregnancy may increase the risk for autism and ADHD.
  
  
• The FDA, in its latest announcement, acknowledges accumulating evidence of a possible association, especially when acetaminophen use is chronic across pregnancy.
  

Evidence Against a Clear Causal Link

• No randomized trial has established causality. Observational studies are vulnerable to confounding: factors like maternal illness, pain, fever, genetic predisposition, or co-use of other medications could account for some or all of the risk.
  
  
• Some large studies using sibling-comparison designs (which adjust for shared familial and genetic factors) have notfound meaningful increases in autism risk among children whose mothers used acetaminophen compared to their siblings who did not.
  
  
• Leading medical bodies like the American College of Obstetricians and Gynecologists (ACOG) affirm that acetaminophen remains the safest pain-and-fever remedy during pregnancy when used appropriately, and any change to practice should be data-driven.
  

What the Trump Administration Is Doing

• The FDA has begun the process of changing labels on acetaminophen-containing medications to include warnings about possible increased risk of neurological conditions (autism, ADHD) when used during pregnancy.
  
  
• A Notice to Physicians has been released to inform them of the evolving research and to encourage careful consideration.
  
  
• Public messaging: pregnant women are being advised to limit acetaminophen use unless medically necessary (for example for high fever), rather than using it routinely.
  
  
• Funding and research: more attention being directed to environmental or non-genetic factors in autism, and exploring leucovorin as a symptomatic treatment.
  

Reactions from Experts & Medical Community
Support, or at least respect, for caution

• Some researchers say that even weak or preliminary associations should prompt more rigorous investigation and updated guidance. They argue that public health policy should err on the side of caution when potential risks exist for vulnerable populations (fetuses).
  
  
• The FDA and other agencies have said they are not claiming “definite causation,” only “possible association,” and that pregnant women should not stop acetaminophen if needed, especially in serious cases.
  

Criticism and concern

• Many in the medical community warn that these statements risk causing public anxiety and possibly harming pregnancy outcomes if women avoid treating fever or pain out of fear. Untreated fever, for instance, can carry its own risks.
  
  
• The label “autism epidemic” has been called into question: the increase in autism diagnosis over time is partly due to changing diagnostic criteria, more screening, better awareness. Thus, raw increases do not necessarily equate to new causative environmental exposures.
  
  
• Pharmaceutical company responses strongly deny that current science supports the claim that acetaminophen causes autism.
  

The Uncertainties That Remain

• Dose, duration, timing: If there is a risk, how much acetaminophen, and during which weeks of pregnancy, contribute most? Is occasional use risky, or only long-term/prolonged use?
  
  
• Confounding variables: Pain, fever, inflammation, and maternal immune response could themselves be factors, independent of drug use. Genetic background is also poorly controlled in many studies.
  
  
• Risk magnitude: Even where associations are found, the effect sizes tend to be modest. Translating that into clinical guidance and risk communication is challenging.
  
  
• Treatment alternatives and trade-offs: What happens if acetaminophen use is reduced—do other pain or fever treatments carry more risk, or do we risk leaving symptoms untreated?
  

What This Means in Practice: Advice for Clinicians

• When counseling pregnant patients, present the current knowledge: that there is suggestive but not definitive evidence of risk. Explain that acetaminophen remains the standard/most used option, and many experts consider it safe when used appropriately.
  
  
• Discuss alternatives and risks of non-treatment (i.e. untreated fever or pain). Sometimes the risk of symptoms may outweigh possible risk of drug; clinical judgment needed.
  
  
• Consider whether acetaminophen use is necessary, limit to lowest effective dose, minimize duration, especially avoid chronic use unless clinically indicated.
  
  
• Stay updated on evolving guidelines and research. The label changes and physician notices suggest regulatory agencies are treating this as a serious signal.
  
  
• Balance patient concerns with risk communication—avoid causing undue fear, but do not dismiss their worries either.
  

Potential Impacts and Policy Implications

• If labels are changed, manufacturers will adjust warnings. This could alter how OTC acetaminophen is sold or perceived. People may start avoiding it more than medically advisable.
  
  
• Increased litigation risk: associations may be used in lawsuits before causal links are definitively established.
  
  
• Insurance and prenatal care guidelines may incorporate these findings—screening questions about acetaminophen use, perhaps revised dosing advice.
  
  
• Public health messaging will need to be carefully managed so as not to undermine trust, especially in maternal health, pain management, and vaccine safety domains.