Tylenol (acetaminophen) has become a contentious issue in the medical community recently. Consumer anxiety is growing following comments about potential side effects from the U.S. Department of Health and Human Services (HHS) and President Donald Trump.
Kenview, the manufacturer, argues that the U.S. is misrepresenting the facts. The pharmaceutical and medical sectors are backing Kenview’s stance. All eyes are now on the Food and Drug Administration (FDA), as its decision will likely shape Tylenol’s future in the market.
Reuters and CNN reported on the 22nd (local time) that President Trump plans to recommend that the FDA advise doctors to warn pregnant women about a possible link between Tylenol use during pregnancy and autism.
Tylenol is an over-the-counter (OTC) medication produced by Kenview, a consumer health product company spun off from Johnson & Johnson (J&J). Its active ingredient, acetaminophen, is widely used globally, including by pregnant women in the U.S., Korea, and other countries.
However, the landscape shifted last month when researchers from Mount Sinai School of Medicine released a report suggesting a potential connection between Tylenol use and autism.
Earlier this month, media outlets reported that U.S. Health Secretary Robert F. Kennedy Jr. was set to announce a possible link between Tylenol use during pregnancy and autism.
This news caused Kenview’s stock to plummet 9.35% to $18.62 on the New York Stock Exchange on the 5th. In response, Kenview’s interim CEO, Kirk Perry, met privately with Secretary Kennedy, but to no avail.
President Trump has since lent his support to Secretary Kennedy’s concerns. Kennedy stated that the FDA will issue guidance for doctors on the risks of acetaminophen during pregnancy and begin the process of updating safety labels.
The market reacted swiftly, with Kenview’s stock price plunging 7.47% to $16.97.
Despite FDA approval, the medical community is pushing back while regulatory authorities—including Korea’s Ministry of Food and Drug Safety—maintain a cautious stance.
Kenview strongly opposes the U.S. administration’s announcement. In a statement, the company emphasized that rigorous studies over the past decade, validated by leading medical experts and global regulatory bodies, have found no credible evidence linking acetaminophen to autism. They maintain that the scientific basis for such a connection remains unestablished.
The U.S. medical community echoes Kenview’s position. Arthur Caplan, head of medical ethics at NYU, criticized President Trump’s remarks as dangerous, unscientific, and rife with misinformation.
The response from U.S. medical professionals is similar. They argue that high fever or pain itself can pose risks to the fetus, and neglecting these symptoms could potentially cause greater harm.
Professor Ahn Jun-yong from Korea University’s College of Health Sciences, recipient of the Young Life Informatics Award for autism spectrum disorder genomics research, expressed on social media that certain Trump administration officials linking Tylenol to autism are disregarding scientific methodology and inciting public anxiety.
An anonymous pharmaceutical industry insider questioned, “If Tylenol is indeed harmful, shouldn’t we investigate all FDA-approved medications containing acetaminophen?”
In response, the FDA has requested manufacturers to submit their opinions and data, stating that it will carefully review all related materials and evidence. They are closely monitoring the situation, as aligning with the FDA’s stance appears to be the logical course of action.
Meanwhile, the FDA maintains a cautious position on this issue. In a letter to physicians, the FDA stated that a causal relationship between Tylenol and autism has not been proven, noting that scientific debate is ongoing. While recent literature reviews have suggested potential associations between Tylenol and autism, many studies have reported contradictory findings.
