Texas AG Ken Paxton claims Tylenol’s manufacturers failed to warn consumers about the risks of taking the drug during pregnancy.
Experts dispute President Trump’s autism claims about Tylenol
Medical experts are defending the safety of Tylenol during pregnancy and disputing President Donald Trump’s autism claims.
Texas Attorney General Ken Paxton announced on October 28 that he will sue the manufacturer of Tylenol for failing to warn consumers about the risks of taking Tylenol during pregnancy.
Paxton filed a lawsuit against pharmaceutical giant Johnson & Johnson and its spinoff company Kenvue, alleging that the companies violated state consumer protection laws by “deliberately ignoring and attempting to silence the science” linking Tylenol to autism and attention-deficit hyperactivity disorder.
The lawsuit also alleges legal violations in which Johnson & Johnson transferred responsibility to Kenvue and separated it in 2023 to protect its assets from lawsuits.
“These companies have lied for decades and intentionally put millions of people’s pockets at risk,” Paxton said in a statement. “Furthermore, seeing a day of reckoning approaching, Johnson & Johnson sought to escape responsibility by illegally shifting the blame to another company. By holding Big Pharma accountable for poisoning our people, we will help make America healthy again.”
The lawsuit comes just over a month after President Donald Trump and top health officials urged pregnant women to stop taking Tylenol painkillers for touting an unproven link between the drug and increased autism diagnoses in children.
Experts say multiple factors, including genetics, contribute to the development of autism. Some medical organizations reject Tylenol autism claims.
“Unfortunately, government officials have touted several observational studies suggesting a potential link between prenatal acetaminophen use and autism…As medical professionals, it is important to emphasize to patients the limitations of these studies and that a causal relationship has not been established,” American College of Obstetricians and Gynecologists President Steven Fleischman said in an Oct. 25 MedPage Today opinion piece.
Tylenol maker says claims are ‘baseless’
Acetaminophen, a generic version of Tylenol, “is the safest pain medication option for pregnant women to use as needed throughout their pregnancy,” Kenbu said in a statement to USA TODAY. The company said it was “deeply concerned by the perpetuation of misinformation” about the drug’s safety.
“We will defend ourselves against these baseless claims and respond according to legal process,” the company said in a statement. “We firmly stand with the global medical community that recognizes the safety of acetaminophen and believe we will continue to prevail in litigation, as these claims lack legal and scientific support.”
Johnson & Johnson said in a statement that the company “sold its consumer health business several years ago, and Kenvue owns all rights and responsibilities associated with the sale of over-the-counter products containing Tylenol (acetaminophen).”
The controversy over acetaminophen and autism intensifies
At a Sept. 22 press conference alongside Health and Human Services Secretary Robert F. Kennedy Jr., President Trump linked Tylenol to an increased risk of autism and called on expectant mothers to “fight like hell to avoid taking Tylenol.”
More than 20 studies, including a report published in August in BMC Environmental Health, have linked frequent acetaminophen use during pregnancy to autism and attention-deficit hyperactivity disorder in children.
However, several studies found conflicting evidence. This included a 2024 study in Sweden of nearly 2 million children, more than 180,000 of whom were exposed to acetaminophen during pregnancy, which found no link between painkillers and children’s risk of autism, ADHD, or intellectual disability.
The Society of Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists both supported the use of acetaminophen during pregnancy.
Fleischman said Tylenol’s label changes “emphasize unfounded risks and only increase fear and confusion about using over-the-counter medications during pregnancy.”
Fleischman wrote that patients are “hearing misleading warnings from the government” and fear they are doing something wrong by taking Tylenol during pregnancy.
“That couldn’t be further from the truth,” Fleischman wrote. “In fact, by avoiding acetaminophen during pregnancy, you may be unintentionally exposing your fetus to the very harm you are trying to prevent, or potentially even greater risk.”
“Although numerous studies have reported an association between acetaminophen and autism, a causal relationship has not been established, and there are studies in the scientific literature to the contrary,” FDA Commissioner Marty McCulley said in a letter to doctors nationwide. Still, the Food and Drug Administration announced that it has begun taking steps to change the labeling of acetaminophen “to reflect evidence suggesting that acetaminophen use by pregnant women may be associated with an increased risk of autism and ADHD in children.”
Recently, a citizen petition has been filed asking the FDA to add a warning to the drug’s label, which Kenbue is asking the FDA to reject.
The Texas lawsuit alleges that the companies “have the authority and obligation” to update their labels but have not taken steps to do so. Had they done so, the lawsuit alleges, the pregnant Texan would have reduced or stopped taking acetaminophen.
“Contrary to the recommendations of our nation’s public health officials, these defendants are effectively encouraging women to ignore the warnings of the Secretary of Health and Human Services and the Secretary of Food and Drugs,” the complaint states.
This story has been updated to add new information.
Contributor: Adrianna Rodriguez, USA TODAY; Reuters
