The FDA has issued warnings concerning potential dangers from acetaminophen and is supporting leucovorin for symptoms related to autism.
President Donald Trump has drawn a connection between the use of Tylenol during pregnancy and rising autism rates in the United States, describing the increase in diagnoses as “one of the most alarming public health developments in history.”
Speaking at a White House briefing on Monday, alongside Health and Human Services Secretary Robert F. Kennedy Jr., Trump advised pregnant women to avoid acetaminophen, the active ingredient found in Tylenol, unless absolutely necessary. He announced that the Food and Drug Administration (FDA) would begin revising warning labels and launch an awareness campaign targeting expectant mothers.
“Taking Tylenol is not good,” Trump stated 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.”
Referencing an increase in autism rates, Trump noted that the condition had become significantly more prevalent over the past two decades. “The meteoric rise in autism is among the most alarming public health developments in history,” he reiterated.
The FDA released two separate announcements, confirming a formal response to mounting evidence of neurological risks associated with acetaminophen during pregnancy. The agency declared it has initiated a label modification for all acetaminophen-containing products, including Tylenol, to reflect studies suggesting a link with autism and ADHD.
“The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen,” said FDA Commissioner Dr. Marty Makary.
The FDA acknowledged that while some studies indicate an association between prenatal acetaminophen use and neurodevelopmental disorders, a causal link has not been established. It emphasized that acetaminophen remains the sole over-the-counter medication approved for fever relief during pregnancy and cautioned that alternatives like ibuprofen and aspirin can pose known risks to fetal development.
Tylenol manufacturer Kenvue responded to these developments by defending the drug’s safety. “We strongly disagree with any suggestion that acetaminophen causes autism,” the company stated, warning that discouraging appropriate use during pregnancy may put mothers and infants at risk from untreated fever or pain.
In a second announcement, the FDA indicated it is initiating approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a condition linked to developmental delays and autistic features. While 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.