Government Advises Pregnant Women About Risks of Acetaminophen Use

U.S. Government To Issue Warning to Medical Community on Tylenol Use During Pregnancy Over Autism Risk

By Mona Austin 

(White House, Sept. 22, 2025) — The U.S. Food and Drug Administration and Department of Health and Human Services today announced a proposal to change safety labeling on acetaminophen (commonly sold in Tylenol and generic pain killers), advising that pregnant women use the drug as little as possible due to “evidence suggesting a correlation” with an increased risk of neurodevelopmental conditions including autism and attention-deficit/hyperactivity disorder (ADHD). The announcement followed statements by President Donald Trump and Health Secretary Robert F. Kennedy Jr., who urged caution in use of the drug during pregnancy and encouraged alternatives.

Trump was ecstatic about the announcement imploring expectant moms saying, "Don't take Tylenol!" Acetaminophen is an active ingredient in Tylenol.

The leaders encouraged  women to consult with their physicians as a disclaimer but strongly recommended acetaminophen use is limited.

---

What’s New

• The FDA is initiating the process for a label change on acetaminophen products. The new label is expected to warn that use during pregnancy may be associated with higher risk of autism and ADHD in children. U.S. Food and Drug Administration

• The agency is  also issuing a “physician’s notice” to alert medical professionals in the interim. Medscape+1

• The directive encourages pregnant women to use acetaminophen only when necessary, at the lowest effective dose, and for the shortest duration needed. Medscape+1

Two mothers with sons on opposite ends of the autism spectrum spoke during the announcement  praised the Trump Administration for their work to find relief and get to the root cause of the complex illness 

---

What the Decision is Based On

The government’s decision draws on recent research and reviews that have identified associations (not proven causation) between prenatal acetaminophen exposure and autism or ADHD, balanced against studies that do not find such links. Key evidence includes:

• A Mount Sinai study published in 2025 using the Navigation Guide methodology, which found that prenatal acetaminophen exposure may increase risks of neurodevelopmental disorders, including autism and ADHD. Mount Sinai Health System

• The Boston Birth Cohort study, which measured acetaminophen and its byproducts in umbilical cord blood of nearly 1,000 births, and found elevated risk of ADHD and autism in children at about 9 years old depending on exposure levels. National Institutes of Health (NIH)

• On the other hand, a large recent sibling‐comparison study from Sweden (data from over 2.4 million children) published in JAMA and funded in part by the NIH/NINDS found no evidence that acetaminophen use during pregnancy causes autism, ADHD, or intellectual disability once shared genetic and environmental factors are controlled for. Drexel University+2National Institutes of Health (NIH)+2

---

What the Change Doesn’t Mean

• Medical authorities such as the Society for Maternal-Fetal Medicine restate that acetaminophen is still considered appropriate for treating pain or fever during pregnancy when necessary, due to risks of untreated fever or pain. Society for Maternal-Fetal Medicine+2The Guardian+2

• The American College of Obstetricians and Gynecologists (ACOG) issued a statement that contradicts claims that acetaminophen use in pregnancy has been shown to cause autism:

  “Suggestions that acetaminophen use in pregnancy causes autism are not only highly concerning to clinicians but also irresponsible…” ACOG
  They note that the highest‐quality studies (including the Swedish sibling study) did not find a significant association. ACOG+2Drexel University+2

---

Study Mentioned: The Swedish Study

• The Swedish study is not 25 years old, but very recent (published 2024), involving over 2.48 million children born between 1995 and 2019, with follow-up through 2021. Healio+1

• It included sibling comparison (i.e. comparing children whose mothers used acetaminophen during pregnancy to their siblings who were not exposed), which helps control for unmeasured genetic and environmental confounders. National Institutes of Health (NIH)+1

• The study found small differences in crude risk rates between exposed vs unexposed children, but no increased risk for autism, ADHD, or intellectual disability in the sibling‐comparison models. Healio+1

---

Reactions

• ACOG strongly criticized the government’s announcement as premature and not supported by “the full body of scientific evidence,” warning that simplifying autism’s causes down to one medication is misleading. ACOG

• Society for Maternal-Fetal Medicine similarly held that acetaminophen remains safe when appropriately used, and that existing research has not shown causation. Society for Maternal-Fetal Medicine

• Autism Science Foundation said the claim was based on “limited, conflicting, and inconsistent science” and cautioned that public health messaging risked confusion and harm. Autism Science Foundation

• Many women have voiced that they see this as a bodily autonomy issue abd prefer the government have a hands-off approach and leave such advice strictly to the general medical community.

---

Symptom Relief for Autism Approved

"We have witnessed a tragic four-fold increase in autism over two decades,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Children are suffering and deserve access to potential treatments that have shown promise. We are using gold standard science and common sense to deliver for the American people.”  

Pregnant women are being told by the government to minimize use of acetaminophen when possible, especially in non‐urgent situations, because of some studies showing a correlation with autism and ADHD. But the major medical associations argue that existing, higher‐quality studies do not show a causal link, and that avoiding acetaminophen outright when experiencing fever or pain might itself be harmful.