The Trump administration is adding a warning to Tylenol over concerns that it could lead to autism and approving another drug to treat the developmental disorder, even while acknowledging that studies on both are inconclusive.
The Food and Drug Administration plans to update labeling for acetaminophen, sold under the brand name Tylenol, to warn of what the agency is calling a “possible association” with autism when the medication is taken during pregnancy. The FDA is sending a letter alerting physicians and the U.S. Department of Health and Human Services is launching a public service campaign about the concerns.
At the same time, the agency is moving to approve the drug leucovorin, also known as folinic acid, as a “potential treatment for speech-related deficits” associated with autism. Once the label update is made, officials said that state Medicaid programs will be able to cover the drug, which is mainly used to prevent harmful effects from chemotherapy, as an autism treatment.
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As they move to make the medication more available, federal health officials said that the National Institutes of Health plans to conduct “confirmatory trials and new research into the impact of leucovorin including safety studies.”
The news came Monday during a wide-ranging White House event where President Donald Trump spoke at length about his ideas about what’s causing rising autism rates, saying in many cases that he was speaking for himself even as he gave specific and direct instructions to Americans.
“Don’t take Tylenol,” Trump said to expectant mothers. “There’s no downside. Don’t take it. You’ll be uncomfortable. It won’t be as easy maybe, but don’t take it. If you’re pregnant, don’t take Tylenol and don’t give it to the baby after the baby is born.”
Trump also advised parents to space out the vaccines given to their children citing “common sense.”
The event Monday follows through on repeated pledges from Trump and Secretary of Health and Human Services Robert F. Kennedy Jr. to make a big announcement on the cause of autism by the end of September.
Trump administration officials said the announcements this week were the first of many on autism in the coming years.
The claims at the press conference alarmed many autism advocates and experts in the field.
“Today’s White House event on autism was filled with dangerous claims and misleading information that sends a confusing message to parents and expecting parents and does a disservice to autistic individuals,” said Dr. Susan J. Kressly, president of the American Academy of Pediatrics. “Regarding autism, we know it is complex, highly variable and increasingly linked to genetics. There is no single, root cause of autism, and there is no single medication that will give every autistic child or adult what they need.”
In addition, Alison Singer, president of the Autism Science Foundation, raised questions about the timing.
“We are unsure why this announcement came today and how the conclusions were drawn,” she said. “No new data or scientific studies were presented or shared. No new studies have been published in the literature. No new presentations on this topic were made at scientific or medical conferences. Instead, President Trump talked about what he thinks and feels without offering scientific evidence.”
Advocates also warned that Trump’s comments suggesting that pregnant women should “tough it out” rather than take Tylenol hearkened back to an outdated view of autism.
“When public officials talk about autism, their words carry weight. Too often, those words have painted the diagnosis of autism as a tragedy, erasing the dignity and humanity of autistic people,” said Katy Neas, CEO of The Arc of the United States. “We remember the days when autism was cruelly blamed on so-called ‘refrigerator mothers.’ We cannot allow stigma, stereotypes and fear drive our public health priorities.”
Only a handful of small studies have been done looking at leucovorin as an autism treatment, according to the Coalition of Autism Scientists, a group of more than 300 researchers in the field. While the researchers said that a rigorous, large-scale trial is warranted, they indicated that “it is premature to claim that leucovorin is an effective treatment for autism.”
With regard to acetaminophen, a recent analysis suggested an association between use during pregnancy and autism, but the findings did not account for the fact that fever during pregnancy is a known autism risk and that’s often why expectant mothers take the drug, the Coalition of Autism Scientists said.
“Rather, the most recent, rigorous study that controlled for unmeasured familiar risks found that acetaminophen did not cause autism,” the group said.
Even the FDA acknowledged that the science on acetaminophen is inconclusive.
“It is important to note that while an association between acetaminophen and neurological conditions has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature,” the agency said in a statement.
The NIH also said Monday that it has kicked off its Autism Data Science Initiative, which includes over $50 million in grants for 13 projects to study causes and treatments of autism. The studies will examine environmental, medical and lifestyle factors in combination with genetics and biology, the agency said.
Autism rates have risen substantially in recent decades from 1 in 150 in 2000 to 1 in 31 currently, according to the Centers for Disease Control and Prevention. Experts largely attribute the rise in prevalence to better awareness, improved screening tools and methods and changes in the diagnostic criteria.
