Donald Trump has urged pregnant women to avoid taking paracetamol, also known by the brand name Tylenol, due to an unproven link between the drug and autism.
He issued the controversial guidance during an announcement in the Oval Office on Monday with Robert F Kennedy Jr, who has been outspoken previously about the link between routine vaccinations and autism (which has been debunked).
The US health secretary said the Food and Drug Administration (FDA) will add a safety label change on Tylenol and launch a public health campaign about the common over-the-counter pain and fever medication.
“Taking Tylenol is not good,” the US president said. “I’ll say it. It’s not good. For this reason [the FDA] are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary.”
Mr Kennedy added that the FDA will approve Leucovorin for autism treatment in children. The drug is currently used to help chemotherapy work better, or reduce its side effects.
“President Trump has tasked me with identifying the root causes of the childhood chronic disease epidemic — including autism,” Mr Kennedy said. “We are assembling teams of world-class scientists to focus research on the origins of the epidemic, and we expect to begin to have answers by September.”
Which of Trump and Mr Kennedy’s claims are true?
“Autism rates have surged by much more than 400 per cent”
Trump described the rise in autism cases as a “horrible crisis,” explaining that “since 2000, autism rates have surged by much more than 400 per cent”.
Autism rates have dramatically risen since 2000, but not by over 400 per cent. According to the US Department of Health and Human Services’ press release on Monday, autism diagnoses have surged by nearly 400 per cent.
1 in 150 people had autism in the US, according to health and education records, which jumped to 1 in 31 by 2022. This is a 384 per cent increase.
It’s also worth noting that this figure indicates a rise in autism diagnoses as opposed to actual cases.
Experts have argued that an increased awareness of autism and the broadening of the diagnostic criteria may also have contributed to an increase in diagnoses. For instance, in 2013, the Diagnostic and Statistical Manual of Mental Disorders, started including subcategories such as Asperger's syndrome in the autism spectrum disorder (ASD) categorisation.
Other factors such as the de-stigmatisation of autism and potential benefits of receiving a diagnosis such as more time to complete exams may also have contributed to the number of people actively seeking out an assessment.
Scientists are also researching the role that environmental risk factors play in autism diagnosis, such as higher parental age, pesticides and air pollution. Most experts agree that more research is needed before making any conclusions.
What causes autism?
- Robert F Kennedy Kennedy said that he expects “to begin to have answers” about “the origins” of the autism “epidemic” by September, but the reality may be more complicated.
- Many experts believe that there is not a single cause and the condition is brought about by a range of genetic and environmental factors.
- Scientists have been researching the role of certain environmental factors in autism diagnosis such as higher parental age, pesticides and air pollution, but experts say more research is needed before making any conclusions.
The Amish have “no autism”
Trump said “there are certain groups of people,” such as the Amish, “that don’t take vaccines and don’t take any pills and they have no autism”.
Scientific research indicates that this isn’t true. A 2008 study published in the Journal of Autism and Developmental Disorders found that autism cases in Pennsylvania's Amish population was comparable to the rest of the population. Another 2011 study found no significant difference in autism rates in Amish and non-Amish populations in Ohio.
The president then referenced autism cases in Cuba. "I mean, there's a rumour and I don't know if it's still or not that Cuba, they don't have Tylenol because they don't have the money for Tylenol, and they have virtually no autism, OK?"
Cuba's autism statistics also undermine Trump’s assertions. According to Ministry of Public Health data and other heath records, 1 in 2,500 Cuban children have autism spectrum disorder. Officials believe this figure is likely an underestimate due to surveillance methodology limitations, according to MEDICC Review.
“Tylenol during pregnancy can be associated with a very increased risk of autism”
Studies have indicated that there could be a link between pregnant women taking Tylenol and autism, however, these results are inconsistent and inconclusive.
A research review led by the dean of Harvard University's Chan School of Public Health published in August found that the likelihood of children developing autism and other neurodevelopmental disorders may increase when exposed to Tylenol during pregnancy. Researchers said that use of the drug during pregnancy should be limited, but it was still important for treating maternal fever and pain, which can be dangerous for fetuses.
However, another study, published in 2024, found no link between Tylenol and autism. Analysing a population of a sample of 2.4 million children born in Sweden between 1995 to 2019 (of which around 7.5 per cent were exposed to acetaminophen during pregnancy), the study found no increased risk of autism linked to acetaminophen.
"Studies that have been conducted in the past, show no clear evidence that proves a direct relationship between the prudent use of acetaminophen during any trimester and fetal developmental issues," the American College of Obstetricians and Gynecologists said in a statement.
The group said that Tylenol is one of the only safe pain relievers for pregnant people.
In a statement issued to the BBC, Kenvue, the company that makes Tylenol, said that without taking the drug, women would have to face a dangerous choice between suffering through conditions such as fever or using unsafe alternatives.
"We believe independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers,” Kenvue said.
High fevers during pregnancy can be harmful to a baby. Untreated high fever in early pregnancy has been linked to miscarriage, neural tube defects, heart defects and other conditions. Some research has also indicated that it can increase the possibility of a fetus developing autism, but findings are so far inconclusive.
Can Leucovorin help people with autism?
Marty Makary, the FDA Commissioner, said that the approval of Leucovorin as an autism treatment will be based on research indicating that children with autism are deficient in folate, a form of vitamin B. Leucovorin is a form of folic acid that provides an active form of folate.
The Autism Science Foundation said that some studies have linked low folate levels during early pregnancy to an increased risk of autism in children, however these findings are not consistent.
Studies in Norway, the US and Israel indicated that mothers who took folic acid supplements around the time of conception had children with a 30-70 per cent lower likelihood of developing autism. However, other studies did not reveal a significant association.
There have been a number of studies that have indicated that leucovorin can help children with autism. A 2021 review analysed the findings of 21 studies that used leucovorin for autism or cerebral folate deficiency. It concluded that children who took the drug generally had improved autism symptoms, but more studies were needed to confirm the findings.
Since then, more studies have indicated that taking folinic acid can help improve symptoms of autism, including social reciprocity. However, researchers have warned that more work is needed before conclusions are drawn.
