US President Donald Trump has triggered a storm of controversy by linking the common pain reliever Tylenol (paracetamol) to autism, despite scientific consensus finding no clear evidence of such a connection. Speaking from the Oval Office, Trump said acetaminophen, the active ingredient in Tylenol, is “no good” for pregnant women and should be used only in cases of extreme fever. He urged expecting mothers to “fight like hell” against routine prescriptions of the drug.
The announcement, made alongside Health Secretary Robert F Kennedy Jr, was followed by a pledge from the Food and Drug Administration (FDA) to add safety warnings, launch a public health campaign, and expedite approval of an alternative treatment for children with autism. The claims, however, were met with immediate resistance from medical experts, pharmaceutical companies, and autism researchers, who warned that discouraging the use of Tylenol could put mothers and babies at risk.
Medical Community Pushes Back
The American College of Obstetricians and Gynecologists (ACOG) issued a rare public rebuke within hours. Its president, Dr Steven Fleischman, said Trump’s announcement “is not backed by the full body of scientific evidence and dangerously simplifies the many and complex causes of neurologic challenges in children.”
ACOG reaffirmed that Tylenol remains one of the only proven safe pain relievers for pregnant women. “Studies that have been conducted in the past show no clear evidence that proves a direct relationship between the prudent use of acetaminophen during any trimester and fetal developmental issues,” the group said.
Health authorities in the UK echoed this stance, noting paracetamol is still considered the safest option for pain and fever in pregnancy. Global bodies, including the World Health Organization, maintain similar recommendations.
The Drugmaker’s Response
Kenvue, the manufacturer of Tylenol, strongly rejected Trump’s remarks in a statement to the BBC. “We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers,” the company said.
It added that acetaminophen is the safest pain reliever for pregnant women, warning that discouraging its use could drive women to either suffer untreated pain and fever—both of which carry fetal risks—or turn to less studied, potentially more harmful alternatives.
What the FDA Plans Next
Health Secretary Robert F Kennedy Jr, long known for promoting controversial health claims, said the FDA will issue a physician advisory highlighting what he described as “potential risk” of Tylenol during pregnancy.
He also said the agency would begin a safety label change and approve leucovorin—a decades-old chemotherapy support drug—for use in autism treatment. Kennedy framed this as part of a larger promise to “find the cause of autism” within five months, a pledge many researchers say is unrealistic given the complexity of the condition.
FDA Commissioner Marty Makary added that research suggests leucovorin may help autistic children with folate deficiencies improve verbal communication. He cautioned, however, that data remain preliminary.
The Science on Tylenol and Autism
The link between acetaminophen and autism has been studied for more than a decade, with conflicting results.
- A 2024 Swedish population study of 2.4 million children found no increased risk of autism, ADHD, or intellectual disability associated with prenatal exposure to acetaminophen. By comparing siblings, the researchers ruled out many genetic and environmental confounders.
- A Harvard-led review in 2025 suggested children may be more likely to develop autism when exposed in utero, but it acknowledged the evidence is mixed and urged caution rather than outright avoidance.
- Other observational studies in the US, Norway, and Israel have pointed to possible associations but fall short of proving causation.
Most experts emphasize that autism arises from a complex mix of genetic and environmental factors, not a single cause.
“There is no robust evidence or convincing studies to suggest there is any causal relationship,” said Monique Botha, professor of social and developmental psychology at Durham University. She added that discouraging acetaminophen risks leaving pregnant women “woefully under-supported” for pain relief.
Folate, Leucovorin, and Autism Trials
While the Tylenol debate dominates headlines, researchers are also exploring whether folate metabolism plays a role in autism.
Low folate levels during pregnancy have been linked in some studies to higher autism risk, though findings remain inconsistent. Mothers who took folic acid supplements around conception saw a 30–70% reduced likelihood of autism in their children in studies conducted in Norway, Israel, and the US.
Leucovorin, a form of folinic acid, can cross the blood-brain barrier more efficiently than standard folic acid. Four small randomized trials have tested its effects on autistic children. A 2016 US trial involving 48 children reported improvements in verbal communication compared to placebo. However, sample sizes remain small, and dosage protocols vary widely.
The Autism Science Foundation urged caution, noting that promising early findings do not justify regulatory approval without large-scale, rigorous trials.
Autism Rates and Rising Concerns
Autism diagnoses have risen sharply in the past two decades. By 2020, 2.77% of US 8-year-olds were diagnosed with autism spectrum disorder, according to the Centers for Disease Control and Prevention (CDC).
Experts caution that the increase reflects expanded diagnostic criteria and greater awareness, not necessarily an epidemic. Still, Trump called it a “horrible crisis” and claimed to have “very strong feelings” about the issue.
Kennedy has previously promoted debunked links between vaccines and autism, a stance that has drawn criticism from medical authorities worldwide. His new focus on Tylenol continues a pattern of controversial claims that often outpace the available science.
Risks of Policy Overreach
Medical professionals warn that sweeping restrictions on Tylenol use in pregnancy could backfire. Maternal fever itself is linked to poor birth outcomes, including miscarriage and developmental delays. Without acetaminophen, pregnant women may turn to non-steroidal anti-inflammatory drugs (NSAIDs), which carry known risks of miscarriage and fetal heart problems.
“This is not a benign issue,” said Dr Fleischman of ACOG. “Discouraging Tylenol without robust evidence puts mothers in a dangerous bind.”
Public health experts also worry about messaging. Conflicting advice could deepen mistrust in institutions and fuel misinformation online.
What Expecting Mothers Should Know
For now, the consensus among global medical authorities remains clear:
- Acetaminophen is safe in pregnancy when used at the lowest effective dose for the shortest possible time.
- Untreated fever and pain can harm both mother and fetus, making responsible use of Tylenol preferable to avoidance.
- Alternative drugs carry higher risks or lack sufficient safety data in pregnancy.
- Folic acid supplements before and during pregnancy are still strongly recommended to reduce risks of neural tube defects and may have additional protective effects.
Pregnant women should always consult their healthcare provider before making medication decisions, especially in light of conflicting political statements.
A Debate That Is Far From Settled
The president’s remarks have reignited debates about the causes of autism and the role of environmental exposures in pregnancy. But experts stress that the search for answers requires rigorous science, not political declarations.
While new avenues—like leucovorin trials—may hold promise, they are still experimental. For now, the best available evidence continues to support Tylenol as the safest, most reliable pain reliever for pregnant women.
As Dr Botha put it: “Pregnant women deserve support, reassurance, and access to safe care—not confusing headlines.”
