“Don’t take Tylenol. Don’t take it.”
President Trump sent a clear message to Americans last year when he said pregnant people should avoid acetaminophen, the active ingredient in Tylenol. She said taking painkillers increased the risk of having an autistic child, although the scientific consensus found no link and untreated fever carries its own risks for the neurodevelopment of pregnant women and their fetuses.
The president and health leaders also pledged to increase access to leucovorin, a little-known cancer drug that helps some people with autism.
A new study says early data shows the Trump administration’s messaging worked.
In the weeks following the September press conference, prescriptions for leucovorin for children soared, while acetaminophen use in emergency departments among pregnant women plummeted, according to Lancet study results published Thursday.
The researchers found that orders for painkillers initially fell by 16%, but leveled off at a 10% drop in the 12 weeks after U.S. health officials warned against their use. There was no statistically significant reduction in drug use among nonpregnant women. Outpatient leucovorin prescriptions also increased by 71% during this period.
“This embodies how much power federal health officials have,” said study author Michael Barnett, a professor at Brown University’s School of Public Health. “Even if nothing changes in the evidence base, even something as ubiquitous and familiar as Tylenol can change the situation to a measurable degree within days.”
Tylenol and autism
Learn more about Tylenol and autism
Burnett and co-author Jeremy Faust, an emergency physician at Brigham and Women’s Hospital in Boston and an assistant professor at Harvard Medical School, mined electronic medical records from hospitals and clinics across the country for their research. Using electronic medical records vendor Epic’s Cosmos database, researchers analyzed data on 88,857 emergency department visits during pregnancy and 853,216 emergency department visits among non-pregnant people. The 10% decrease means there were 22 fewer Tylenol orders per 1,000 visits, with “orders” indicating a medical professional pinging a hospital’s dispensing system or sending a prescription to a pharmacy.
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The data do not indicate whether clinicians or patients are responsible for the decline, nor do they provide insight into how over-the-counter acetaminophen use changed outside of the emergency department. More worryingly, it also doesn’t indicate whether patients used Tylenol instead of other painkillers, said Lisa Kroen, director of the Kaiser Permanente Autism Research Program, who was not involved in the study.
“Tylenol is a safe drug and is the only safe drug to control pain and fever during pregnancy. We do not know if people were using paracetamol instead of other painkillers that are known to be dangerous (during pregnancy), such as ibuprofen,” she said.
Acetaminophen use leveled off by the end of 12 weeks, but leucovorin prescription accelerated. Leucovorin is a niche treatment with modest efficacy for some autism patients. The 71% increase partially reflects the smallness of the market, with the actual increase being just 17 prescriptions per 100,000 visits, but Barnett said the spike appeared after the Trump administration promoted the drug on national television, which is no different than direct-to-consumer drug advertising.
Leucovorin may be effective in treating autism, researchers say, but leucovorin ruins parents’ hopes
However, the rise is also a concern. Health officials are tasked with curbing the rising rate of autism diagnoses, which Health Secretary Robert F. Kennedy Jr. called an “epidemic.” They also removed a federal webpage highlighting the harms of controversial autism treatments and proposed a national autism registry that had sparked fear and distrust in the community. Telling parents of children with autism that this unproven drug will improve their child’s symptoms, or telling the Food and Drug Administration to reauthorize a decades-old version of leucovorin that was removed from the market, only makes a bad situation worse, Kroen said.
“It is extremely harmful to the American people, children and adults, for the government to make statements that are not supported by rigorous scientific evidence,” she said. “Scientists and doctors need to re-educate people about what we really know and what is scientifically proven, or needlessly proven, because the government has erased so much good research by issuing these false statements.”
The findings do not change the Trump administration’s approach to this issue.
“This is the most pro-patient administration in U.S. history, and conveying messages about the specific neurological risks to infants is another example of our administration’s commitment to telling the truth about public health, something we will not do in the Biden administration,” said Health and Human Services Secretary Andrew Nixon.
