Kenvue Brands LLC, the maker of Tylenol®, issued the following statement in response to scientifically unfounded litigation filed by the Office of the Attorney General of Texas.
What Matters Most
Nothing is more important to us than the health and safety of the people who use our products. We are deeply concerned by the perpetuation of misinformation on the safety of acetaminophen and the potential impact that could have on the health of American women and children.
Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy. Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives. High fevers and pain are widely recognized as potential risks to a pregnancy if left untreated.
Acetaminophen is also one of the most widely studied pain relievers and fever reducers in infants and children, and numerous randomized, controlled clinical trials support the safety of acetaminophen in infants and children when used as directed.
Additionally, rigorous, independent research, endorsed by leading medical professionals and global health regulators, confirms that there is no proven link between taking acetaminophen and autism.
What Does the Medical Community Say
Medical providers and health authorities agree current evidence does not support claims that acetaminophen causes autism.
FDA itself has evaluated the scientific evidence for over a decade and repeatedly concluded the data does not support a causal association between taking acetaminophen and autism. This position is as recent as what was explained in FDA’s Notice to Physicians. FDA also previously evaluated, and rejected, updating the pregnancy warning on the product label.
Why Is This Happening
We believe there is a deliberate distortion of the facts being driven by the plaintiffs’ bar as this latest filing, which is a common tactic used by plaintiffs’ lawyers in product liability cases, is yet another attempt to revive legal claims that have already been thrown out of federal court.
The allegations in this complaint are not new and repeat allegations that have been made in the underlying product liability cases.
It is critical that expecting women understand that health professionals—not lawyers—are best positioned to advise them on whether taking acetaminophen is appropriate based on their unique medical conditions, as indicated on our product label for Tylenol®.
What Are Next Steps
We will vigorously defend ourselves against these claims and respond per the legal process. We stand firmly with the global medical community that acknowledges the safety of acetaminophen and believe we will continue to be successful in litigation as these claims lack legal merit and scientific support.
Cautions Concerning Forward-Looking Statements
This statement contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, litigation related to acetaminophen. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Kenvue Brands LLC and its affiliates.
A list and descriptions of risks, uncertainties and other factors can be found in Kenvue Inc.’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 29, 2024 and subsequent Quarterly Reports on Form 10-Q and other filings, available at www.kenvue.com or on request. Kenvue Brands LLC and its affiliates undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or developments or otherwise.