A Controversial Report Threatens to Upend Trust in a Common Pregnancy Medication

Generated by AI AgentCoin World
Tuesday, Sep 9, 2025 12:21 am ET2min read
KVUE--
Aime RobotAime Summary

- Kenvue shares fell over 10% as HHS Secretary RFK Jr. plans to link acetaminophen use during pregnancy to autism in a report.

- Scientific consensus remains divided, with FDA and major medical groups affirming acetaminophen's safety for pregnant women.

- Legal precedents and mixed studies (including a 2024 Swedish study) highlight inconsistent evidence on the drug-autism link.

- Analysts caution proving causality will be challenging, but the report's September release remains a key focus for investors.

Shares of KenvueKVUE-- Inc., the over-the-counter drugmaker behind Tylenol, plummeted over 10% on Friday amid reports that U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. is set to release a report suggesting a potential link between acetaminophen use during pregnancy and autism. The Wall Street Journal reported that the findings could also recommend a form of folate for the treatment of the disorder, though scientific consensus remains divided on the validity of such claims. Kenvue has long faced legal and scientific scrutiny over similar allegations, with multiple lawsuits in recent years being dismissed due to a lack of conclusive evidence [3].

The potential report comes as part of a broader initiative under the Trump administration to investigate factors contributing to the rising rates of autism in the U.S., where approximately one in 31 children are now diagnosed. Kennedy has positioned autism research as a central mission for his HHS, promising to "get to the bottom" of the so-called "epidemic" by September. However, critics within the medical community, including the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, have emphasized that acetaminophen remains a recommended and safe option for pregnant women experiencing pain or fever—conditions that, if untreated, can pose greater risks to fetal development [2].

The U.S. Food and Drug Administration (FDA) has similarly stated that it has not found "clear evidence" that acetaminophen use during pregnancy causes adverse outcomes. The agency advises pregnant women to consult healthcare providers before taking any medication, including over-the-counter drugs. Kenvue has reaffirmed its stance that there is no causal link between the drug and autism and highlighted that leading medical organizations concur with the safety profile of acetaminophen during pregnancy [3].

Scientific research on the matter has yielded mixed results. A 2024 study involving over 2.4 million children born in Sweden found no increased risk of autism associated with maternal acetaminophen use. Similarly, a 2023 federal court ruling dismissed a major lawsuit against Kenvue, citing insufficient scientific backing for the claim. However, some smaller studies have noted a potential association between acetaminophen exposure in utero and neurodevelopmental conditions like autism and ADHD. A 2023 review of 46 epidemiological studies showed 27 reporting a possible link, while nine found no significant correlation and four even suggested protective effects [1].

The proposed HHS report has drawn sharp criticism from autism researchers and public health experts, who argue that it lacks the robust, peer-reviewed scientific foundation necessary to draw such conclusions. The Autism Science Foundation has stated that the genetic and environmental causes of autism are complex and cannot be reduced to a single factor. The foundation also noted that any association between acetaminophen and autism is based on limited and inconsistent evidence. In addition, the suggested use of folate derivatives for treating autism remains speculative, with current research indicating that the science is in early stages [2].

Analysts have weighed in on the potential market implications of the report. BNP Paribas analyst Navann Ty noted that proving a causal relationship between acetaminophen and autism presents a significant challenge, especially given the legal precedent set in Kenvue’s favor in previous litigation. Despite the sharp decline in Kenvue’s stock, the company remains confident in its product’s safety and in the alignment of its practices with regulatory and medical guidelines. The outcome of the HHS report will likely remain a focal point for investors, healthcare professionals, and the public as the September deadline approaches [3].

Source:

[1] Tylenol-maker shares hit after report RFK Jr will suggest ... (https://www.bbc.com/news/articles/cx25l92q9xgo)

[2] HHS responds to report about autism and acetaminophen (https://www.npr.org/sections/shots-health-news/2025/09/06/nx-s1-5532143/hhs-responds-to-report-about-autism-and-acetaminophen)

[3] Kenvue stock drops 10% on RFK Jr. Tylenol autism report (https://www.cnbc.com/2025/09/05/rfk-tylenol-autism-kenvue-stock-for-url.html)

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