President Trump announced on Monday that his administration has concluded that some cases of autism may be linked to pregnant women’s use of acetaminophen, the active ingredient in Tylenol, and said the medication should be used sparingly and only if absolutely needed during pregnancy.
Flanked by the nation’s top health officials in the White House’s Roosevelt Room, Trump outlined a dramatic overhaul to health agencies’ approach to autism. The Food and Drug Administration will recommend doctors dramatically scale back acetaminophen use in pregnant women to the lowest effective dose for the shortest necessary duration, and update the medication’s label. The Department of Health and Human Services will also launch a nationwide public information campaign to inform families.
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The FDA is taking steps to make available the first drug for children with autistic symptoms tied to folate deficiency in the brain. The medication, leucovorin, has long been used during cancer treatments and has shown some success in improving verbal ability in small numbers of people with autism in small studies. State Medicaid programs will cover leucovorin.
“The meteoric rise in autism is among the most alarming public health developments in history. There’s never been anything like this,” Trump said. He recommended that pregnant women limit use of acetaminophen except in case of an extremely high fever — “if you can’t tough it out.”
Autism researchers say that the scientific literature does not justify the Trump administration’s moving away from Tylenol use during pregnancy and making leucovorin prescriptions available for children with autism. They worry that parents who are desperate to help their kids will turn to an unproven solution — when the history of autism treatments is riddled with purported “cures” that harm more than help.
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“I worry that families are going to be putting in a lot of resources and investment into trying to get this treatment [leucovorin] without data showing that it is effective, potentially at the expense of the behavioral interventions and speech therapy and things that we know can be helpful,” Shafali Jeste, a pediatric neurologist who specializes in autism at Children’s Hospital Los Angeles, said prior to the announcement.