The FDA warns of potential risks from acetaminophen and backs leucovorin for autism-related symptoms
US President Donald Trump has drawn a connection between the use of Tylenol during pregnancy and rising autism rates in America, calling the increase in diagnoses “one of the most alarming public health developments in history.”
Speaking at a White House briefing alongside Health and Human Services Secretary Robert F. Kennedy Jr. on Monday, Trump said pregnant women should avoid acetaminophen, the active ingredient in Tylenol, unless absolutely necessary. He said the Food and Drug Administration (FDA) would begin updating warning labels and launch an information campaign aimed at pregnant women.
“Taking Tylenol is not good,” Trump said during the event. “They are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary… If you can’t tough it out, if there’s a problem, you’re going to end up doing it, but ideally you don’t take it at all.”
Citing an increase in autism rates, Trump said the condition has become far more prevalent over the last two decades. “The meteoric rise in autism is among the most alarming public health developments in history,” he said.
The FDA issued two separate news releases confirming a formal response to growing evidence of neurological risks linked to acetaminophen during pregnancy. The agency said it has initiated a label change for all acetaminophen-containing products, including Tylenol, to reflect studies suggesting an association with autism and ADHD.
In the last 22 years, autism rates among children have increased nearly 400%.
“The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen,” FDA Commissioner Dr. Marty Makary said.
The FDA acknowledged that while some studies show an association between prenatal acetaminophen use and neurodevelopmental disorders, a causal link has not been established. It stressed that acetaminophen remains the only over-the-counter medication approved for fever relief during pregnancy and warned that alternatives like ibuprofen and aspirin can pose known risks to fetal development.
Tylenol manufacturer Kenvue responded to the developments by defending the drug’s safety. “We strongly disagree with any suggestion that acetaminophen causes autism,” the company said, warning that discouraging appropriate use during pregnancy may put mothers and infants at risk from untreated fever or pain.
In another announcement, the FDA said it is initiating approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a condition linked to developmental delays and autistic features. Though the agency cautioned that more studies are needed to assess the drug’s full efficacy in autism-related populations, it said the initiative reflects a broader strategy to repurpose existing medications for neurological conditions.
