On September 22, 2025, the Trump administration announced that the Food and Drug Administration (FDA) would notify doctors about a possible link between Tylenol use during pregnancy and an increased risk of autism in children. This claim, led by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., has sparked debate due to conflicting scientific evidence. The administration also highlighted leucovorin, a drug typically used for cancer and anemia, as a potential autism treatment. However, experts stress that the Tylenol-autism link lacks strong evidence, and the drug remains a safe option for pregnant women. Here’s a clear breakdown of the issue and what you need to know.
1. The Trump Administration’s Claims
The announcement came during a press conference where President Donald Trump stated that the FDA would urge doctors to limit Tylenol (acetaminophen) use during pregnancy unless it’s medically necessary, such as for high fevers. The administration pointed to a recent research review suggesting an association between prenatal Tylenol use and autism. This review, conducted by Harvard and Mount Sinai researchers, analyzed 46 studies and found a possible link between acetaminophen exposure in the womb and neurodevelopmental issues like autism and ADHD.
The announcement follows a pledge by HHS Secretary Robert F. Kennedy Jr. to identify the cause of rising autism rates by September 2025. Kennedy, who has previously claimed vaccines cause autism (a theory debunked by decades of research), now focuses on Tylenol as a potential factor. The administration also promoted leucovorin, a form of folate, as a possible treatment for autism symptoms, particularly for those with folate deficiencies.
2. What the Science Says About Tylenol and Autism
Despite the administration’s claims, most studies show no causal link between Tylenol and autism. The Harvard-Mount Sinai review found an association, but experts caution that association does not mean causation. For example, a large Swedish study of 2.5 million children, including 185,909 exposed to acetaminophen in utero, found no link to autism when comparing siblings—one exposed to Tylenol and one not. This sibling comparison helps rule out other factors, like genetics or family health conditions, that might influence results.
Dr. Danelle Fisher, a pediatrician at Providence Saint John’s Health Center, emphasized, “Studies like this are not proving anything other than an association.” She compared the Tylenol-autism link to saying eating ice cream during pregnancy causes autism—both show correlation, not causation. Additionally, mothers who take Tylenol during pregnancy often have conditions like infections or chronic pain, which could contribute to autism risk, further complicating the data.
3. Why Tylenol Is Important for Pregnant Women
Tylenol is widely regarded as the safest pain and fever reliever for pregnant women. Unlike other drugs like ibuprofen or aspirin, which can increase risks of miscarriage or birth defects, acetaminophen is recommended by major medical groups, including the American College of Obstetricians and Gynecologists (ACOG). Christopher Zahn, ACOG’s Chief of Clinical Practice, stated, “Pregnant patients should not be frightened away from the many benefits of acetaminophen, which is safe and one of the few options pregnant people have for relief.”
Untreated fevers during pregnancy can lead to serious issues, such as neural tube defects, miscarriage, or premature birth. Limiting Tylenol use without strong evidence could put pregnant women and their babies at risk by leaving fevers or pain untreated.
4. Leucovorin as an Autism Treatment
The Trump administration also suggested leucovorin, a form of vitamin B9 (folate), as a potential autism therapy. Some studies show that children with autism may have folate deficiencies in the brain, and leucovorin could help improve symptoms like speech difficulties in specific cases. However, the science is still early. Dr. Fisher noted that while small studies show promise, “no large-scale studies have demonstrated a consistent finding.” The Autism Science Foundation agrees, stating that more research is needed before leucovorin can be broadly recommended.
The FDA has approved leucovorin for treating cerebral folate deficiency, a rare condition linked to some autism symptoms, but it’s not a cure for autism. Its use as an autism therapy remains off-label and requires further study.
5. Why the Announcement Is Controversial
The Trump administration’s claims have drawn criticism from medical experts for lacking solid evidence. The FDA’s own statement was more cautious, noting that “a causal relationship has not been established” and that the Tylenol-autism link is an “ongoing area of scientific debate.” Major medical groups, like ACOG and the Society for Maternal-Fetal Medicine, continue to endorse Tylenol as safe for pregnant women when used as directed.
Critics argue that the announcement could cause unnecessary fear. Dr. Fisher said, “Every time the government disregards the scientific method and states untrue things about medical issues, they are playing on fear.” The focus on Tylenol also comes after a Wall Street Journal report predicted the HHS would link the drug to autism, causing a 9% drop in stock for Kenvue, Tylenol’s manufacturer. Kenvue defended Tylenol, stating that over a decade of research shows no credible link to autism.
6. Understanding Autism and Its Causes
Autism is a complex neurological condition affecting about 1 in 31 children in the U.S., according to the CDC. Its rates have risen, likely due to better awareness, improved screening, and broader diagnostic criteria. Experts agree that autism has multiple causes, including genetic and environmental factors, but no single cause has been identified. Dr. Fisher explained, “Autism is a complex spectrum of disorders, which largely has a genetic basis.” While environmental factors, like parental age, may play a role, the evidence does not support Tylenol as a cause.
7. What Pregnant Women Should Know
For pregnant women, the key takeaway is to follow medical advice from trusted professionals. Tylenol remains the safest option for managing pain or fever during pregnancy when used at the lowest effective dose for the shortest time. Avoiding treatment for fevers or pain could pose greater risks to both mother and baby. If you’re concerned about autism or medication use, talk to your doctor for personalized guidance.
The Trump administration’s announcement has sparked debate, but the scientific consensus remains clear: there’s no proven link between Tylenol and autism. Pregnant women should feel confident using Tylenol as recommended while researchers continue to study autism’s causes and treatments like leucovorin.
