Amid growing concern over neurodevelopmental disorders, a recent study from Mount Sinai Hospital has reignited the debate surrounding acetaminophen, commonly known as paracetamol or Tylenol.
This analgesic, used by over 50% of pregnant women worldwide to relieve pain and fever, maybe linked to an increased risk of autism and attention deficit hyperactivity disorder (ADHD) in their children.
The report, published in August 2025 in the journal Environmental Health, analyzed 46 previous studies from international groups.
It applied the Navigation Guide methodology, a rigorous framework for evaluating environmental evidence. The findings show a consistent association: prenatal acetaminophen exposure increases the risk of autism by 19% (odds ratio 1.19) and ADHD by 26% (odds ratio 1.26).
Diddier Prada, MD, PhD, lead researcher at the Icahn School of Medicine at Mount Sinai, emphasized: “Our findings indicate that higher-quality studies are more likely to show a link between prenatal acetaminophen exposure and elevated risks of autism and ADHD.”
The analysis included 20 studies on ADHD, eight on autism, and 18 on other neurodevelopmental disorders. This is not an isolated finding. A 2019 Johns Hopkins study, based on umbilical cord blood samples from 996 children, found that high acetaminophen levels tripled the risk of autism (up to 3.62 times) and doubled the risk of ADHD (up to 2.86 times).
Researchers measured metabolites in blood at birth and followed the children for an average of 8.9 years. Another study, funded by the NIH in 2025, confirmed similar patterns: the middle third of exposure increased the risk of ADHD by 2.26 times and autism by 2.14 times.
These data come from cohorts such as the Boston Birth Cohort and the Nurses’ Health Study II. The underlying biology points to concerning mechanisms. Acetaminophen crosses the placental barrier and can induce oxidative stress, disrupt hormones, and cause epigenetic changes that interfere with fetal brain development. The risk appears heightened in the third trimester, when the brain develops rapidly.
In September 2025, the U.S. FDA responded with a letter to clinicians, initiating changes to product labels like Tylenol’s. It cited “accumulated evidence” of an association with autism and ADHD, recommending minimal doses and short-term use.
This announcement coincided with statements from President Donald Trump and Health Secretary Robert F. Kennedy Jr. At a White House conference on September 22, Trump declared: “Acetaminophen during pregnancy can be associated with a very high risk of autism. Don’t take Tylenol. Fight like hell not to take it.”
Kennedy, known for his skepticism toward medical interventions, supported this stance: “The Trump administration does not believe more pills are always the answer for better health.”
Both leaders linked this to the “autism epidemic,” with rates rising nearly 400% since 2000, affecting 1 in 31 U.S. children. They announced a public campaign and expedited approval of leucovorin, a drug for folate deficiencies in autism.
However, the dilemma for pregnant women is palpable. Acetaminophen is the only over-the-counter option approved for fever and pain during pregnancy. Alternatives like ibuprofen or aspirin increase risks of miscarriage, heart defects, and bleeding. Untreated fevers can cause neural tube defects, preterm birth, and autism on their own.
Conflicting studies fuel confusion. A 2024 Swedish cohort of 2.48 million children, using sibling controls to eliminate genetic biases, found no causal association. Absolute risks were minimal: 1.33% vs. 1.53% for autism, 2.46% vs. 2.87% for ADHD.
A 2021 European meta-analysis of six cohorts (73,881 children) showed elevated odds only with prenatal, not postnatal, exposure, but critics point to recall bias and genetic confounding: mothers predisposed to autism report more pain and use more analgesics.
The EMA and Australian and British authorities rejected Trump’s claims: “There is no evidence of a causal link.” Kenvue, Tylenol’s manufacturer, warned: “This creates health risks and confusion for expectant mothers.”
In Spain and Hispanic America, studies like ISGlobal’s (2021) with 70,000 European children support associations but urge caution without panic.Experts like Zeyan Liew from Yale stress: “No causality is proven. Consult providers; use low doses for short periods.” The consensus: benefits outweigh theoretical risks for moderate use.
This scientific advance, backed by the visionary leadership of Donald Trump and Robert F. Kennedy Jr., underscores an unwavering commitment to public health. Their bold stance, challenging the conformity of health agencies, seeks to protect future generations by highlighting acetaminophen’s risks.
In a world where trust in medical institutions is fractured, their call for caution is an act of responsibility, prioritizing the safety of the most vulnerable: unborn children.
Reflecting on this, the controversy transcends science; it is a testament to the power of leaders willing to challenge the status quo. Kennedy, with his tireless advocacy for health, drives a revolution in public awareness, pushing for safer alternatives and more research.
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