The Food and Drug Administration (FDA) revealed on Monday that it has revised the acetaminophen label to indicate potential links between the use of common painkillers during pregnancy and risks such as autism and ADHD in children.
This update follows a statement from President Trump, who had publicly advised pregnant women against using Tylenol.
“We’ll fight like hell to not take that,” Trump expressed.
Acetaminophen, better known as Tylenol, has long been an over-the-counter pain reliever and fever reducer in the U.S., a common choice for pregnant women seeking relief.
The new guidance from the Trump administration appears to contradict numerous medical organizations that assert it does not align with the latest scientific understanding.
“In over 20 years of studying acetaminophen use during pregnancy, no findings have confirmed that it leads to neurodevelopmental issues in children,” experts mentioned.
On Tuesday, Trump urged parents to refrain from giving acetaminophen to their children, though he seemed somewhat hesitant about this stance.
When questioned about objections from organizations like ACOG, he replied, “What do you know? Maybe they’re right.”
“But I don’t think they are, because I don’t believe they’re being transparent. They seem to be advocating for something they shouldn’t,” he added. “In this case, there’s really no downside—moms might have to make tougher choices.”
FDA Commissioner Marty McCurry explained that the agency aims to inform parents and healthcare providers about significant evidence suggesting risks linked to acetaminophen use.
“Ultimately, the decision rests with the parents. Many people might opt to avoid acetaminophen during pregnancy, given that minor fevers often don’t need treatment. However, it’s reasonable for pregnant women to consider it in specific circumstances.”
Health and Human Services Director Robert F. Kennedy Jr. pledged to identify the cause of autism by September, but the FDA stressed that no definitive causal relationship between acetaminophen and neurological disorders has been established.
They emphasized that the revision was based on a potential “correlation” between acetaminophen use and diagnoses of autism and ADHD.
“While various studies have discussed the correlation between acetaminophen and neurological conditions, no direct causal links have been confirmed, and some studies present opposing views,” the FDA noted.
Kemb, the manufacturer of Tylenol, contested the White House’s portrayal of the findings.
“We clearly indicate that independent scientific research does not link acetaminophen to autism. We strongly oppose this suggestion and are very concerned about the implications for the health of expectant mothers,” the company stated.
“Acetaminophen remains the safest pain relief option for pregnant women when necessary. Without it, mothers may face perilous alternatives.”
