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Texas Attorney General Ken Paxton is suing the makers of Tylenol, claiming the companies hid alleged dangers that the drug posed to children's brain development.
The lawsuit comes a month after President Donald Trump promoted an unproven link between taking Tylenol - also known as paracetamol - during pregnancy and autism in children.
Paxton is suing Johnson & Johnson, which previously sold the drug, the only pain reliever recommended for pregnant women, and Kenvue, which now manufactures it.
In a statement, he said they "betrayed America by profiting off of pain and pushing pills regardless of the risks."
Kenvue says there is no credible evidence tying Tylenol to autism.
"These corporations lied for decades, knowingly endangering millions to line their pockets," Paxton, a Republican, said.
Kenvue said in a statement that it was "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".
On its website, Kenvue also said it had "continuously evaluated the relevant science and there is no credible data that shows a proven link between taking acetaminophen and autism".
Organizations representing doctors and healthcare providers agree.
The American College of Obstetricians and Gynecologists has said acetaminophen - the main ingredient in Tylenol - is one of the few options for pregnant women to treat pain and fever, which can pose serious health risks if left untreated.
"In more than two decades of research on the use of acetaminophen in pregnancy, not a single reputable study has successfully concluded that the use of acetaminophen in any trimester of pregnancy causes neurodevelopmental disorders in children," the group said.
The lawsuit cites recent announcements from the Trump administration in arguing the drug is allegedly unsafe.
Last month, Trump raised alarms from public health officials when he told pregnant women to "fight like hell" not to take Tylenol when ill.
The US Food and Drug Administration (FDA) then issued a notice that doctors should consider limiting the use of Tylenol, while also stating that "a causal relationship" between the drug and autism in children has not been established.
Health Secretary Robert F Kennedy Jr, who oversees the FDA, had pledged in April to undertake "a massive testing and research effort" that would determine the cause of autism in a matter of months.
But experts cautioned that finding a single cause of autism - thought by researchers to be the result of a complex mix of genetic and environmental factors - would not be simple. Autism is a form of lifelong neurodivergence and disability that affects how people experience and interact with the world, and is diagnosed using doctors' observations.
In his court filing, Paxton - a Trump ally who is running for US Senate - alleges Kenvue and Johnson & Johnson "willfully ignored and attempted to silence the science" around acetaminophen and autism.
The lawsuit seeks to make the companies "destroy any marketing or advertising" that claims Tylenol is safe for pregnant women.
The Texas lawsuit echoes the complaints of a group of parents of children with autism and ADHD who sued the makers of Tylenol in 2022.
A federal judge dismissed the case, saying research from the parents' expert witnesses was not conclusive.
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