FDA reaffirms acetaminophen safety during pregnancy, urges medical consultation after Trump’s remarks

Speaking from the Oval Office alongside Health and Human Services Secretary Robert F. Kennedy Jr. and other senior officials, Trump said federal health agencies would advise expectant mothers to avoid Tylenol “unless medically necessary.” He urged them to consult their doctors if they “can’t tough it out.”

Acetaminophen, widely sold under the brand name Tylenol, has been in use since the 1950s and is considered the safest over-the-counter pain reliever during pregnancy. It is commonly recommended for fever and pain relief and is an active ingredient in hundreds of cold and flu medications. Tylenol’s original manufacturer, Johnson & Johnson, spun off the brand in 2023.

Kenvue, the current maker of Tylenol, rejected the claims in a statement, saying: “Sound science clearly shows that taking acetaminophen does not cause autism.” The company emphasized that the medicine is not only approved for use during pregnancy but also essential in certain medical situations.

Even though the president himself admitted that no alternatives to Tylenol exist for pregnant women and “it doesn’t hurt not to take it,” adding that it’s better to “tough it out,” health experts warn that avoiding fever-reducing or pain-relieving medication during pregnancy can significantly increase risks for both the mother and the child.

“Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy. Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives,” it said. The company added that numerous researches, endorsed by leading medical professionals and global health regulators, confirm lack of credible evidence linking acetaminophen to autism.

US officials also announced that the FDA would approve leucovorin — a folinic acid drug typically used to reduce chemotherapy side effects — for treatment of children with autism. The medication is more commonly prescribed for certain anemias and in colorectal and pancreatic cancer regimens.

Medical experts stress that autism is a complex condition shaped by both genetic and environmental factors, and no credible evidence supports a causal link with acetaminophen use. According to the World Health Organization (WHO), research suggests risk factors may include advanced parental age, maternal diabetes, prenatal exposure to air pollutants, prematurity, and low birth weight.

Some studies have also found associations with exposure to certain anti-seizure medications, such as valproate. WHO emphasizes that “more research is needed to better understand the role of each factor and how they interact with genetic variations.” The agency has also reiterated that vaccines do not cause autism — a claim Trump also raised during the press conference.

The FDA confirmed that acetaminophen remains safe for use during pregnancy when taken as directed. “To date, FDA has not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes. However, FDA continues to recommend consultation with a health care professional before use of any medicine, including acetaminophen, during pregnancy,” the agency said. No new studies or data were presented to support the administration’s claims.

Trump further raised concerns about vaccines due to rising autism rates. To address this, Kennedy announced the launch of an “all-agency” initiative involving the National Institutes of Health, the FDA, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services to investigate possible causes of autism.

The American Psychiatric Association responded to the White House statement, stressing that “vaccines do not cause autism” and that claims of such a link have been “repeatedly discredited.” The association called autism “a complex disorder” that exists “on a spectrum of neurodiversity,” emphasizing that treatment decisions should be made between patients and their doctors. It also noted that leucovorin “has not been a recommended treatment” and urged the administration to prioritize evidence-based care and long-term research.

Earlier this month, Florida’s administration announced plans to eliminate all vaccine mandates, becoming the first state in the country to pursue such a step.