Texas Attorney General Ken Paxton has filed a lawsuit against the makers of Tylenol, alleging they violated the Texas Deceptive Trade Practices–Consumer Protection Act.
The state claims Johnson & Johnson and Kenvue concealed the risks of acetaminophen, Tylenol’s active ingredient, by marketing it as the only safe painkiller for pregnant women. The suit alleges the companies “willfully ignored and attempted to silence the science that prenatal and early-childhood exposure to their acetaminophen products can cause autism spectrum disorder and ADHD in children.”
“The Tylenol labels on these products contain no warning that there is any risk of ASD or ADHD if a woman ingests the drug while pregnant,” the lawsuit states. “Rather, defendants have marketed the drug as a completely safe pain medication for pregnant women and children. This campaign has been effective, as approximately 65% of pregnant women take some form of acetaminophen during pregnancy, and most do so for minor aches and pains.”
The lawsuit follows claims made during the Trump administration that Tylenol use among pregnant women was linked to higher rates of autism. The Food and Drug Administration notes that “acetaminophen is the only over-the-counter drug approved for use to treat fevers during pregnancy, and high fevers in pregnant women can pose a risk to their children.”
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Medical experts and public health officials have cautioned against drawing causal links between over-the-counter medications and autism without substantial peer‑reviewed evidence.
Kenvue, the maker of Tylenol, said it stands with public health officials and believes there is no credible evidence linking acetaminophen to autism.
“We believe independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with any suggestion otherwise and are deeply concerned about the health risks and confusion this poses for expecting mothers and parents,” Kenvue said in a previous statement. “The facts are that over a decade of rigorous research, endorsed by leading medical professionals and global health regulators, confirms there is no credible evidence linking acetaminophen to autism. We stand with the many public health and medical professionals who have reviewed this science and agree.”
Autism Speaks, a nonprofit advocacy group, reports that one in 31 children in the U.S. has a form of autism, along with one in 45 adults.
“Women who are pregnant and families considering new therapies for autism should always consult with their doctor,” the group said in a statement following last month's announcement. “While some observational studies have suggested possible associations between Tylenol (also known as acetaminophen) and autism, it is important to note that they have not — to date — proven causation, which we know to be influenced by many other factors such as genetics, parental health and environment.”
The lawsuit asks the court to bar the makers of Tylenol from engaging in “any deceptive or unfair trade practice related to the manufacturing, distributing, advertising or selling of Tylenol in Texas” and to impose civil penalties of $10,000 per violation.
Johnson & Johnson divested its consumer health business years ago, and all rights and liabilities associated with the sale of its over-the-counter products, including Tylenol (acetaminophen), are owned by Kenvue," Johnson & Johnson said in reaction to the suit.
