The U.S. Food and Drug Administration says no link between Tylenol use during pregnancy and autism has been proven<\/p>\n<\/h3>\n
By I. Edwards HealthDay Reporter<\/b>
\n<\/b><\/p>\n
WEDNESDAY, Oct. 29, 2025 (HealthDay News) \u2014 Texas Attorney General Ken Paxton<\/a> has filed a lawsuit accusing Kenvue<\/a>, the maker of Tylenol, and its former parent company, Johnson & Johnson, of misleading consumers about the safety of the popular pain reliever during pregnancy.<\/p>\n Filed Tuesday in Texas state court, the lawsuit claims the companies continued to sell acetaminophen<\/a> products despite knowing the drug could be linked to autism and ADHD<\/a> \u2014 an allegation that federal health officials have said is still unproven.<\/p>\n Paxton, a Republican candidate for U.S. Senate, called the case an effort to hold \u201cBig Pharma accountable,\u201d saying in a statement, \u201cby holding Big Pharma accountable for poisoning our people, we will help Make America Healthy Again.”<\/p>\n Kenvue called the lawsuit \u201cbaseless,\u201d saying its product is safe when used as directed.<\/p>\n Acetaminophen \u201cis the safest pain reliever option for pregnant women as needed throughout their entire pregnancy,” the company stated.<\/p>\n Johnson & Johnson<\/a>, which spun off Kenvue in 2023, said the new company now holds all rights and liabilities for Tylenol<\/a>.<\/p>\n The U.S. Food and Drug Administration (FDA) recently said it is beginning a process to change Tylenol\u2019s labeling. The change would note that prenatal acetaminophen use \u201cmay be associated\u201d with an increased risk of certain developmental disorders. <\/p>\n The FDA added, however, that \u201ca causal relationship has not been established.\u201d<\/p>\n While acknowledging that some studies suggest a possible connection, the FDA noted that others have found no link, and that acetaminophen remains the only nonprescription fever and pain reliever approved for use during pregnancy, The Washington Post <\/em>reported.<\/p>\n Paxton\u2019s lawsuit claims that Johnson & Johnson\u2019s own internal research showed a potential connection in 2014 between acetaminophen and autism, but the company did not make that information public.<\/p>\n Many of the same arguments appeared in earlier federal lawsuits filed by individuals claiming Tylenol caused autism in their children.<\/p>\n Those cases, which were consolidated in 2022, were dismissed after a judge ruled that the plaintiffs\u2019 expert witnesses were unreliable. The decision is under appeal, The Post<\/em> said.<\/p>\n Meanwhile, some advocacy groups, like the Informed Consent Action Network, have urged the FDA to add autism and ADHD warnings to acetaminophen products.<\/p>\n Kenvue has publicly opposed those label changes, saying the proposed warnings are \u201cunsupported by the scientific evidence.\u201d<\/p>\n More information<\/strong><\/p>\n The American Academy of Pediatrics has more on acetaminophen safety<\/a>.<\/p>\n