[비즈한국] The Wall Street Journal (WSJ) recently reported that Robert F. Kennedy Jr., the U.S. Secretary of Health and Human Services, plans to release a report on the link between Tylenol and autism. As concerns grow regarding pregnant women taking Tylenol, the WSJ reported that the upcoming document is highly likely to suggest that low folate levels combined with Tylenol use during pregnancy could be potential causes of autism.

While some research results suggest that "acetaminophen," the main ingredient in Tylenol, may pose risks to fetal development, there are also many criticisms regarding the limitations of such studies. Acetaminophen-based antipyretic analgesics are generally considered safer for pregnant women than non-steroidal anti-inflammatory drugs (NSAIDs) due to their long history of use. However, as with any medication, consulting a doctor before use is essential.
Will the link between Tylenol and autism be proven?
Immediately following the WSJ report, Kenvue, the manufacturer of Tylenol, issued a statement saying, "There is nothing more important than the health and safety of the people who use our products," and expressed its position that it "believes there is no causal relationship" between Tylenol use during pregnancy and the development of autism.
However, the WSJ alleged that Kenvue interim CEO Kirk Perry had a private meeting with Secretary Kennedy to lobby him, asking him "not to mention Tylenol as a cause of autism." In response, Kenvue refuted this, stating, "We merely exchanged scientific opinions with the Secretary's office regarding product safety," and added, "Global health regulatory agencies, independent public health organizations, and medical professionals hold the same position."
This is not the first time Secretary Kennedy has formalized research into the causes of autism. When he announced plans for large-scale screenings and research at a cabinet meeting last April, President Donald Trump remarked, "There could be an artificial cause. It could be injections," and since the Secretary is also known as a vaccine skeptic, it was expected that "vaccines" would be targeted. However, the situation has escalated as "Tylenol" has emerged as a potential cause.
Similar research in 2019 met with counterarguments
A similar study was published in 2019. A research team led by Professor Wang Xiaobin, a pediatrician at Johns Hopkins University Hospital, analyzed data from the "Boston Birth Cohort," which followed 996 mothers and their children. The team suggested that the use of the antipyretic analgesic Tylenol (acetaminophen) during pregnancy could increase the risk of Attention Deficit Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD) in children. Blood samples were collected from the children's umbilical cords at birth, and the levels of acetaminophen and its metabolites were measured.
The analysis showed that children in the highest acetaminophen group were 2.86 times more likely to be diagnosed with ADHD, and those in the middle group were 2.26 times more likely compared to the lowest group. For ASD diagnosis rates, the highest group was 3.62 times more likely, and the middle group was 2.14 times more likely than the lowest group. Those in the highest acetaminophen group also faced a 3.38 times higher risk of being diagnosed with both ADHD and ASD compared to the lowest group.
However, this study also faced criticism for its limitations. Hyagriv Simhan, a professor of obstetrics and gynecology at the University of Pittsburgh School of Medicine, pointed out that "umbilical cord blood levels only reflect the moment of birth," and do not account for exposure throughout the entire pregnancy. Kimford Meador, a professor of neurology at Stanford University, also noted that "family history and genetic factors were not considered," adding, "Since other analgesics can also affect the fetus, one should not avoid only acetaminophen but instead weigh the benefits and risks."
Ministry of Food and Drug Safety: "We will take necessary measures after the U.S. report is released"
The American College of Obstetricians and Gynecologists emphasizes that "acetaminophen use after consulting a doctor is safe," recently reiterating that "there is no clear evidence linking its cautious use to fetal developmental issues."
South Korea’s Ministry of Food and Drug Safety also advises in its medication safety manual that "acetaminophen is the safest antipyretic analgesic for pregnant women to take." While it is known to be safe regardless of the timing or duration of administration, they strongly recommend consulting a doctor or pharmacist before use. The Ministry plans to review the U.S. report once it is published and take necessary measures if required.