Claiming that "acetaminophen may cause autism," Trump warns pregnant women to avoid taking Tylenol

Former U.S. President Donald Trump warned pregnant women to avoid taking Tylenol, claiming that its main ingredient, acetaminophen, is associated with autism, despite the lack of widely recognized scientific evidence supporting this risk.

On September 22, Trump stated during a joint event with U.S. Health Secretary Xavier Becerra:

Taking Tylenol is not good, I will say it straight. For this reason, I strongly recommend that women limit the use of Tylenol during pregnancy unless medically necessary.

The U.S. government also announced plans to initiate procedures to modify the safety labels of related medications and launch a nationwide public health campaign.

Tylenol manufacturer Kenvue stated that "independent, reliable scientific research" indicates that taking acetaminophen does not lead to autism. On Monday, the company's stock price plummeted nearly 7.5%, closing at a historic low, but rebounded over 4.48% in after-hours trading.

Scientific Controversy and Existing Evidence

Acetaminophen is often recommended to pregnant women as an alternative to ibuprofen for fever relief. Over the past decade, studies on the association between acetaminophen and autism have emerged, but the conclusions have been inconsistent.

In pharmacology, acetaminophen can be classified as an "antipyretic analgesic," which not only has fever-reducing effects but also provides some pain relief. It can reduce fever and alleviate muscle soreness, which is why it is commonly added to Tylenol and various over-the-counter cold and fever medications.

Although a paper published in 2021 in Nature Reviews Endocrinology called for caution in its use, a large-scale study published in 2024, analyzing data from nearly 2.5 million Swedish siblings, found that the risk of offspring developing autism did not increase when mothers took acetaminophen during pregnancy.

Meanwhile, several professional organizations, including the American College of Obstetricians and Gynecologists, have raised objections, arguing that "patients should not forgo the many benefits of acetaminophen out of fear."

Some scientists also warned that it is premature to advise pregnant women to stop using the drug without conclusive evidence, as it is the only recommended antipyretic for pregnant women at certain stages of pregnancy. They stated that untreated fever for extended periods could harm fetal development.

The U.S. Food and Drug Administration (FDA) noted in updated information on its official website last month that the agency "has not found clear evidence that appropriate use of acetaminophen during pregnancy leads to adverse pregnancy, birth, neurobehavioral, or developmental outcomes."

Legal Disputes and Regulatory Trends

Before Trump's warning, the related controversy had already entered the judicial process.

Previously, there were numerous lawsuits in the U.S. claiming that exposure to the over-the-counter pain reliever Tylenol during pregnancy led to autism in children.

However, in 2023, U.S. District Judge Denise Cote dismissed the scientific evidence behind these lawsuits, stating it was based on "flawed science." She also excluded the testimony of plaintiff expert witness Andrea Baccarelli, arguing that he did not employ "sufficient rigor" in assessing the association between acetaminophen and neurodevelopmental disorders Currently, the plaintiff has filed an appeal, and a debate is expected to take place in Manhattan later this year. Legal experts indicate that the Department of Health and Human Services (HHS) statement regarding autism may be considered by the appellate judges, but it cannot replace the legal standards for admissible evidence.

Meanwhile, U.S. Secretary of Health Kennedy has made it clear that the FDA will issue a physician notification regarding the risks of using acetaminophen during pregnancy and initiate the process to change drug safety labeling.

This suggests that, despite the controversies at the judicial level in the U.S., the pressure from administrative regulation is increasing.

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