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U.S. President Donald Trump (Photo = Yonhap News) |
[Alpha Biz= Kim Jisun] Washington/Seoul, September 23, 2025 – U.S. President Donald Trump has stirred controversy after claiming that acetaminophen-based pain reliever Tylenol may cause autism when taken during pregnancy. Medical experts and professional associations swiftly rejected the remarks, citing insufficient scientific evidence.
On September 22 (local time), President Trump stated at the White House,
“Taking Tylenol during pregnancy increases the risk of autism. Unless medically necessary, it should be avoided.”
He referenced U.S. health statistics indicating a nearly 400% increase in autism prevalence since 2000 and further claimed, “There is no autism in Cuba because Tylenol is not available there.”
FDA’s Position: Association Reported, Not Proven
Tylenol, containing acetaminophen as its sole active ingredient, is one of the most widely used analgesics globally. Unlike ibuprofen or aspirin, which are not recommended during pregnancy, acetaminophen is often considered the only viable pain reliever for expectant mothers.
On the same day, the U.S. Food and Drug Administration (FDA) announced that it has begun revising acetaminophen product labels and issued advisories to physicians nationwide. The move follows studies suggesting possible associations between acetaminophen use during pregnancy and neurological disorders such as autism and ADHD.
However, the FDA emphasized,
“Associations have been reported, but causality has not been established. There are also studies presenting opposing results.”
Dr. Marty Makary of the FDA added that while most mild fevers require no treatment, acetaminophen use “may still be a reasonable option in certain circumstances,” stressing that “the final decision rests with parents.”
Medical Community Pushes Back
According to The New York Times, the American College of Obstetricians and Gynecologists (ACOG) reiterated that “Tylenol is safe for use during pregnancy.” The Wall Street Journal also noted that while some studies suggest potential links, “scientific evidence remains weak.”
A 2019 study published in JAMA reported a correlation between acetaminophen levels in newborns and autism risk.
However, a large-scale Swedish study published in 2024 in the same journal, covering 2.5 million children, found no significant association.
Dr. Helen Tager-Flusberg, Professor Emerita at Boston University and a leading autism researcher, told Nature:
“I do not believe acetaminophen causes autism. Rigorous studies have found no clear evidence of even small risks, and if any exist, they are minimal.”
Industry and Regulatory Responses
Kenvue, manufacturer of Tylenol, stated,
“Tylenol is among the most extensively studied medicines in history. Over a decade of rigorous research has found no reliable evidence linking acetaminophen to autism.”
Korea’s Ministry of Food and Drug Safety (MFDS) also said on September 23 that it has requested data and clarification from the manufacturer following the FDA’s announcement, adding that it will “carefully review the available evidence.”
알파경제 Kim Jisun (stockmk2020@alphabiz.co.kr)
