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Just days after the Department of Health and Human Services released a report highlighting a potential link between Tylenol use in pregnant women and rising autism rates in America, FDA Commissioner Dr. Marty Makary announced pending approval on a drug that could treat the disorder.
“This, I think, is the most exciting part of the announcement…we are going to approve a drug called Luecovorin, for the treatment of autism, and it may help 50 to 60 percent of kids with autism,” he said during an interview on C-SPAN.
According to the FDA, the agency is working to understand how to utilize this pre-existing cancer drug (also known as Wellcovorin), to safely utilize it in treating “cerebral folate deficiency.”
Makary explained, “What we have learned about autism in our research since we were charged with identifying the causes of autism, is that one of the causes is that the receptor on the blood-brain barrier that allows folate to be transported into the brain is blocked by an antibody. In other words, autism may be an autoimmune disease for some kids, and you can test for that antibody.”
He said that this phenomenon, in some children, causes the brain to become starved of folate – a critical component of neurotransmitter production, such as serotonin and dopamine, which are key to nervous system regulation.
“The drug that we are going to approve bypasses that blocked receptor,” Makary added. “And studies have shown that up to two-thirds of kids with a folate deficiency will see an improvement in their autistic symptoms – that’s exciting news!”
On Monday, President Donald Trump stood alongside Health and Human Services Secretary Robert F. Kennedy Jr. while recommending that pregnant women not take Tylenol, citing the agency’s report suggesting a link between using the historically “safe” painkiller during pregnancy and the nation’s alarmingly high rates of autism in children.
“Tylenol is not good,” the president said, per RSBN. “All pregnant women should talk to their doctors about limiting the use of this medication while pregnant.”



