President Donald Trump announced Monday that the FDA will warn physicians about potential autism risks from prenatal Tylenol use while simultaneously initiating approval of the first treatment for an autism-related condition. "We have a response today to the autism crisis," declared FDA Commissioner Marty Makary, MD, MPH, from the Oval Office.
The FDA will notify physicians about potential autism risks associated with acetaminophen use during pregnancy, despite ongoing scientific debate over the connection. “They are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary,” Trump said. He advised expectant mothers: “If you’re pregnant, don’t take Tylenol—except in medically necessary situations such as treating a fever.” Trump further advised parents to “spread out” vaccines and to delay the hepatitis B vaccine until age 12, saying it is sexually transmitted. NIH Director Jay Bhattacharya, MD, PhD, supported the administration's position, stating that "genetics alone can't explain the sharp increase" in autism rates. Dr. Mehmet Oz, now CMS Administrator, echoed the warning approach. Trump credited HHS Secretary Robert F. Kennedy Jr. as "the man who brought this issue to the forefront of American politics, along with me."
In a parallel move, the FDA has initiated approval of leucovorin calcium tablets for cerebral folate deficiency (CFD), a condition that affects folate transport to the brain and causes developmental delays with autistic features. CFD patients experience social communication challenges, sensory processing issues, repetitive behaviors, seizures, and coordination problems. "We have witnessed a tragic four-fold increase in autism over two decades," said Makary. "Children are suffering and deserve access to potential treatments that have shown promise." The FDA is working with GSK to update labeling for the existing drug Wellcovorin. Additional studies are needed for broader patient populations with similar symptoms.
The action follows a systematic analysis of literature from 2009 to 2024, and the combined announcements represent a comprehensive response to rising autism rates to address both potential prevention and treatment approaches.
