Acetaminophen, more commonly recognized by the brand name Tylenol, has been recommended by physicians to pregnant women as a safe fever-reducer and effective pain-reliever for decades. However, in September of this year, President Donald Trump and U.S. Health and Human Services Secretary Robert F. Kennedy Jr. issued a warning regarding a supposed link between Tylenol use during pregnancy and an increased risk of autism in children. These warnings have received massive media attention and spread rapidly across social media platforms, but the scientific evidence behind these claims remains far from conclusive.
The warnings and statements presented by President Trump and Secretary Kennedy risk confusing the public by blurring the crucial distinction between correlation and causation. Correlation merely suggests that two variables are related in some way, while causation indicates that a change in one variable directly causes a change in the other. The difference may sound subtle, but in science and law it is fundamental. Correlation alone is insufficient to prove a cause-and-effect relationship, as other confounding variables may be present. The studies cited by President Trump and Secretary Kennedy merely demonstrate correlation; none provide credible evidence that Tylenol use during pregnancy causes autism in children.
A comprehensive review of 46 studies investigating the relationship between Tylenol use during pregnancy and neurodevelopmental disorders found that more than half showed only minimal associations, while the remainder showed no evidence of increased risk whatsoever. In another large-scale Swedish study involving 2,480,797 children born from 1995 to 2019, researchers found no statistically significant link between prenatal Tylenol use and autism in children. Additionally, the U.S. Food and Drug Administration (FDA) has reiterated that no causal relationship has been established between Tylenol and neurodevelopmental disorders.
Despite this, President Trump has gone so far as to advise pregnant women to “tough it out” and avoid Tylenol entirely. Yet Tylenol is commonly taken for fever and pain, both of which can pose serious health risks if left untreated. In fact, research suggests that untreated fever during pregnancy may increase the risk for autism in the child as much as forty percent in the second trimester, and more than 300 percent for pregnant women who reported three or more fevers after the twelfth week of pregnancy.
Discouraging pregnant women from using Tylenol, the only over-the-counter pain-reliever approved to use while pregnant, could increase health risks for both mothers and their unborn children. Without access to safe fever and pain management, women may turn to unsafe alternatives or endure conditions that themselves elevate the risk of poor health and pregnancy outcomes.
From a legal perspective, the warnings presented by President Trump and Secretary Kennedy raise significant concerns. The FDA has initiated a process to update the labeling of products containing Tylenol in response to the claims of a potential association between pregnancy use and neurodevelopmental disorders, despite the lack of evidence establishing causation. Manufacturers of Tylenol could be exposed to product-liability litigation because the label change process shifts the standard of care and opens the door to claims of inadequate warnings or information. Additionally, when a highly influential public figure advises pregnant women to “tough it out” and avoid the only approved over-the-counter pain-reliever for use in pregnancy, healthcare providers could face increased exposure to malpractice claims if fever or pain in pregnancy is left untreated and injury results. The discourse created by the warnings from President Trump risks generating confusion among pregnant women about safe Tylenol use, which may lead to under-treatment of fever or pain or even to the substitution of Tylenol with less safe alternatives, increasing potential legal exposure across providers, insurers, and manufacturers.
As of now, both the FDA and the Centers for Disease Control (CDC) continue to advise that acetaminophen remains the safest and most effective over-the-counter pain relief option for pregnant women.