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The US Food and Drug Administration said it will add a warning to the label of painkiller Tylenol citing increased risk of autism, as President Donald Trump on Monday urged pregnant women not to take it.
At a White House event, Trump repeatedly said pregnant women and babies should not take Tylenol. “Just don’t take it unless it is absolutely necessary,” he said. “Fight like hell not to take it.”
He also urged people to space out childhood vaccines for measles, mumps, and rubella so they are not given all at once.
The FDA simultaneously said it has started the process for a label change for acetaminophen, the active ingredient in Tylenol, to warn of increased risks for autism and attention deficit disorders. The regulator also sent a letter to doctors saying clinicians should consider minimising acetaminophen during pregnancy for routine low-grade fevers.
Monday’s announcement sent shares of Tylenol’s parent company Kenvue down more than 7 per cent, extending a sell-off that began earlier this month following news of the administration’s conclusions. The company’s shares have dropped to their lowest level since it was spun out of Johnson & Johnson in 2023.
Kenvue, which also sells Listerine, Aveeno, and Neutrogena brands, said Tylenol is not associated with autism.
“We believe independent, sound science clearly shows that taking acetaminophen does not cause autism,” Kenvue said on Monday. “Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy.”
Additionally on Monday, the FDA said it is updating the label for leucovorin, a treatment for low folic acid, to say the drug could be a treatment for autism. Following the label update, state Medicaid programmes will be able to cover leucovorin for autism in a partnership with the Centers for Medicare and Medicaid Services. The regulator said leucovorin manufacturer GSK has preliminarily agreed to work with the agency on the relabelling effort.
FDA commissioner Marty Makary said: “A growing body of evidence suggests that some children suffering from autism are folate deficient within the brain — a problem that can be treated with leucovorin. Given the extent of the current autism epidemic, physicians should immediately have this treatment option available for candidate children.”
Autism affects about 3 per cent of US children and about one in 20 boys, the health department said on Monday. Health secretary Robert F Kennedy Jr has been warning childhood vaccines could be triggering autism.
Concerns have circulated about acetaminophen as a potential cause of autism for years. Trial lawyers have filed lawsuits against Kenvue alleging Tylenol links to autism and attention deficit disorders, but the cases have been struck down in court.
Additional reporting by Lauren Fedor in Arizona
