FDA to issue warning on Tylenol use in pregnancy over autism concerns

President Donald Trump announced Sept. 22 that his administration will issue a physician advisory and add new warning labels to acetaminophen, citing studies linking the drug’s use during pregnancy to an increased risk of autism and other neurodevelopmental disorders. 

Joined at the White House by Health and Human Services Secretary Robert F. Kennedy Jr., Food and Drug Administration (FDA) Commissioner Marty Makary, and other top officials, Trump said the FDA will issue an advisory to doctors “strongly recommending that women limit Tylenol use during pregnancy unless medically necessary.”

Kennedy later added that the advisory will apply to products with acetaminophen — the active ingredient in Tylenol.

“Since 2000, autism rates have surged by much more than 400%,” Trump said. “Instead of attacking those who ask questions, everyone should be grateful for those who are trying to get the answers to this complex situation.”

After Trump’s opening remarks, Kennedy said he has directed “an unprecedented all-agency effort to identify all causes of autism, including toxic and pharmaceutical exposures.” 

He added that HHS recognizes “acetaminophen is often the only option for fever and pain in pregnancy” and urged clinicians to use “the lowest effective dose for the shortest necessary duration, and only when treatment is required.” 

Makary cited major studies from Johns Hopkins, Boston University, Harvard, Yale, and Mount Sinai that he said could no longer be ignored. 

“To quote the dean of the Harvard School of Public Health,” Makary said, “there is a causal relationship between prenatal acetaminophen use and neurodevelopmental disorders of ADHD and autism spectrum disorder.”

In addition to the Tylenol warning, officials announced what they described as the first FDA-recognized treatment pathway for autism: leucovorin, a prescription form of folate. 

Dr. Mehmet Oz, who heads the Centers for Medicare and Medicaid Services, said: “The FDA, based on NIH research, is approving prescription leucovorin for treatment of autistic children.”

Oz added that the agency is issuing guidance to “convene states and existing research networks to support NIH and FDA in their research efforts on prescription leucovorin, while also maintaining the privacy of all patients.” 

Officials also rolled out the National Institutes of Health’s (NIH) Autism Data Science Initiative, which they said will devote an additional $50 million to advanced research on studying the cause of autism.