The Food and Drug administration (FDA) is alerting healthcare providers to a possible connection between acetaminophen (Tylenol) use during pregnancy and a heightened risk of autism and attention-deficit/hyperactivity disorder (ADHD). This proclamation comes as some medical organizations maintain that such claims lack sufficient evidence.

During a Sept. 22 press conference, President Donald Trump referenced Centers for Disease Control and Prevention (CDC) data regarding autism diagnosis rates in the United States. A CDC study released in April estimated that 1 in 31 children in the U.S. are diagnosed with autism by age 8. This is up from 1 in 54 in 2016,and 1 in 150 in 2000.

Researchers have suggested that the increasing rates of autism diagnoses might potentially be linked to factors such as environmental influences, increased awareness and educational efforts, as well as evolving screening and diagnostic practices. However, President Trump has stated that he believes the rise in autism prevalence is related to acetaminophen use during pregnancy.

“So taking tylenol is not good. Alright, I’ll say it. It’s not good,” President Trump said, accompanied by HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Mehmet Oz, MD. “For this reason, they are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary,” notably in cases of “extremely high fever.”

“Fight like hell not to take it,” he said later in the conference.

In response to these concerns, the FDA is updating acetaminophen safety labels. the agency has also initiated the approval process for leucovorin calcium tablets for both adults and children who have cerebral folate deficiency, a condition the agency has linked to autistic characteristics. Leucovorin is currently approved for managing side effects of chemotherapy.

the National Institutes of Health (NIH) is allocating $50 million to establish an Autism Data Science Initiative and fund 13 research projects focused on autism.

“The FDA is responding to clinical and laboratory studies that suggest a potential association between acetaminophen use during pregnancy and adverse developmental outcomes, including later diagnosis for ADHD and autism,” Mr. Kennedy said.

Though, a 2024 study involving over 2 million children in Sweden found no link between acetaminophen use during pregnancy and an increased risk of autism, ADHD, or intellectual disability in children.

“Fight like hell not to take it,”

The Society for Maternal-Fetal Medicine and the American college of Obstetricians and Gynecologists (ACOG) released statements on Sept. 22, affirming that acetaminophen remains a safe and appropriate option for managing pain and fever during pregnancy.

Mr. Kennedy also mentioned that the federal government is exploring various potential causes of autism, including vaccines.

During the press conference, President Trump made claims that children receive 80 vaccines under current recommendations and implied that vaccines cause autism. Though, extensive scientific research contradicts this assertion, with 16 population-based studies across multiple countries finding no association between vaccines and autism.

“There are certain groups of people that don’t take vaccines and don’t take any pills, that have no autism. That have no autism. Does that tell you something? That’s currently- is that a correct statement by the way?” President trump said, turning to Mr. Kennedy, who said there are studies showing this trend among Amish people.

The president also suggested that the measles, mumps, and rubella (MMR) vaccines should be administered as three separate vaccines. The week prior, a CDC vaccine advisory panel voted against recommending the quadrivalent MMR and varicella (chickenpox) vaccine for children under the age of 4.