President Donald Trump shocked the medical community by announcing that the U.S. Food and Drug Administration (FDA) would warn doctors about a possible link between acetaminophen (paracetamol/Tylenol) use during pregnancy and autism in children. Standing alongside Health Secretary Robert F. Kennedy Jr., Trump described the drug as “a very big factor” in autism and urged pregnant women to avoid it unless absolutely necessary.
The FDA confirmed it has begun a label change process for acetaminophen products and is reviewing data on potential neurological risks. At the same event, the administration announced plans to approve leucovorin (folinic acid) as a treatment option for some autism patients, with Medicaid coverage for low-income families.
But while the White House framed this as a breakthrough, the announcement has triggered intense scientific backlash worldwide.
Do Painkillers Like Paracetamol Cause Autism?
Paracetamol is one of the most widely used medicines in pregnancy—taken by over half of pregnant women globally. It has long been recommended because alternatives like aspirin and ibuprofen carry known risks for fetal development.
Some studies have suggested a possible association between prenatal acetaminophen exposure and neurodevelopmental disorders such as autism and ADHD. A 2025 Harvard–Mount Sinai meta-analysis reviewing 46 studies found signals of increased risk.
However, causation has not been established. High-quality research—most notably a 2024 Swedish sibling study of 2.5 million children—found that when comparing siblings exposed and unexposed to the drug, the autism risk disappeared. This suggests genetics and maternal health factors are far more likely to explain the association.
What Do Health Authorities Say?
Global regulators have firmly rejected Trump’s claims:
- FDA Commissioner Marty Makary admitted that while associations have been observed, “a causal relationship has not been established.”
- The UK Medicines and Healthcare products Regulatory Agency (MHRA) stated bluntly: “There is no evidence that taking paracetamol during pregnancy causes autism.”
- The European Medicines Agency (EMA) confirmed there is “no new evidence” requiring any changes in medical guidance.
- The World Health Organization (WHO) described the data as “inconsistent” and warned against drawing premature conclusions.
Australia’s Therapeutic Goods Administration (TGA) also reaffirmed: “Robust scientific evidence shows no causal link between paracetamol use in pregnancy and autism or ADHD.”
Medical Community Pushback
Doctors and advocacy groups have strongly criticized the administration’s stance:
- The American College of Obstetricians and Gynecologists (ACOG) called the announcement “highly unsettling” and lacking reliable data.
- The Society for Maternal-Fetal Medicine (SMFM) stressed that “acetaminophen use during pregnancy has not been shown to cause or increase autism risk.”
- Kenvue, the manufacturer of Tylenol, rejected the claims, insisting that “independent, sound science clearly shows acetaminophen does not cause autism.”
- The National Autistic Society condemned the statement as “dangerous, anti-science, and irresponsible.”
Why Experts Say the Real Risk Is Misinformation
Scientists warn that discouraging pregnant women from using acetaminophen could have serious unintended consequences.
Untreated fever and severe pain during pregnancy are themselves associated with higher risks of birth complications and autism. By casting doubt on the only safe over-the-counter pain relief option, health authorities fear women may be left without treatment—potentially putting both mother and child at greater risk.
As the Autism Science Foundation noted, many studies fail to account for why acetaminophen was taken in the first place—such as fever, which itself is a known autism risk factor.
Global Consensus: No Causal Link
Despite the White House announcement, the scientific consensus remains unchanged:
- Autism is a complex neurodevelopmental condition, primarily driven by genetic and biological factors.
- Large-scale, sibling-controlled studies show no causal relationship between acetaminophen use in pregnancy and autism.
- Health agencies worldwide—including the FDA, WHO, EMA, MHRA, TGA, and major medical colleges—continue to recommend acetaminophen as the safest pain relief during pregnancy when used as directed.
Bottom Line
President Trump’s claim that paracetamol causes autism has sparked headlines, but global health authorities overwhelmingly disagree. For now, doctors stress that pregnant women should follow medical guidance—not political announcements—when managing pain and fever.
As WHO reminded in its statement: “The evidence remains inconsistent. Vaccines do not cause autism. Painkillers, when used correctly, do not cause autism. Science must guide public health.”
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