Trump links autism to Tylenol, vaccines; claims not backed by science

US President Donald Trump on Monday claimed that the use of acetaminophen (commonly known as Tylenol) during pregnancy could be "associated with a very increased risk of autism," a statement that contradicts decades of medical research and expert consensus supporting the safety of the drug for pregnant women, CNN reported.

Speaking from the Oval Office, Trump stated that the US Food and Drug Administration (FDA) would soon notify physicians to limit the recommendation of Tylenol during pregnancy unless "medically necessary," such as for the treatment of fever, adding, "if you can't tough it out."

According to CNN, researchers broadly agree that autism spectrum disorder (ASD) is caused by a complex combination of genetic and environmental factors, and the data regarding any potential link between acetaminophen and autism remains inconclusive and evolving.

In a statement on Sunday, Tylenol manufacturer Kenvue said, "Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy. Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives."

Trump was joined at the announcement by US Health and Human Services Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary, NIH Director Jay Bhattacharya, and CMS Administrator Mehmet Oz. During the briefing, Trump also questioned existing childhood vaccine protocols, calling for delays in the administration of vaccines like the hepatitis B shot, which is currently given to newborns. He suggested that "too many different things are going into that baby," though he provided no scientific evidence to support his claim.

Medical experts and health agencies, including the Centres for Disease Control and Prevention (CDC), have consistently found no link between childhood vaccinations and autism. Numerous peer-reviewed studies have thoroughly debunked such theories.

In contrast to Trump's strong warnings, the FDA's current position remains more measured. In a recent letter to physicians, the agency stated that "a causal relationship has not been established" between acetaminophen use during pregnancy and autism, and acknowledged the existence of "contrary studies in the scientific literature."

Kennedy stated that the Department of Health and Human Services (HHS) is planning a public education campaign regarding the use of acetaminophen in pregnancy. He urged clinicians to rely on their professional judgment in advising patients.

Earlier this month, Tylenol manufacturer Kenvue stated that it had held a "scientific exchange" with HHS officials on the matter and advised pregnant women to consult their healthcare provider before using any over-the-counter medication.

"Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy," the company said in a statement Sunday, cited CNN.

"Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives.

"The facts are that over a decade of rigorous research, endorsed by leading medical professionals and global health regulators, confirms there is no credible evidence linking acetaminophen to autism. We stand with the many public health and medical professionals who have reviewed this science and agree."

Meanwhile, CNN reported that the FDA has approved prescription leucovorin, a high-dose calcium folinic acid typically used in chemotherapy, for treatment in some children with autism.

The agency also reinstated approval for Wellcovorin, a branded version of leucovorin produced by GSK, after requesting the inclusion of data related to cerebral folate deficiency (CFD), a condition involving low folate levels in the fluid surrounding the brain and spinal cord.

The FDA requested that GSK submit a new application to include data on cerebral folate deficiency (CFD), a condition in which there is a low level of folate in the cerebrospinal fluid, the fluid surrounding the brain and spinal cord.

The number of people diagnosed with autism has been rising. About 1 in 31 children were diagnosed with autism spectrum disorder by age 8 in 2022, up from 1 in 36 in 2020, according to the US Centres for Disease Control and Prevention. In 2015, it was 1 in 68 children.

Experts attribute this increase to several factors. In 2013, the psychiatric community broadened its definition of autism, awareness of symptoms has grown, and acceptance of the diagnosis has increased, making parents more willing to seek help. There has also been a concerted effort to screen more young children for autism, as early intervention can significantly improve symptoms and long-term skills.

"Just as there are multiple genes involved in different cancers, at least 100 genes are involved in autism," Dr. Peter Hotez, a pediatrician and co-director of the Center for Vaccine Development at Texas Children's Hospital, stressed that the causes of autism are highly multifactorial. He noted that claiming a single "smoking gun" that can cure or cause autism would be irresponsible.

"So for every different autism gene, there's really a different form of autism, and it's unlikely that a single unifying chemical agent is going to be able to address even a small proportion of those 100-plus autism genes," Hotez, who has a daughter with autism and has written a book on the condition, told CNN on Monday.

"Look, I say this as the parent of a child with autism: You want a simple answer, right? But what is so clear is that there is not always a simple answer. There are so many things to consider, and it is very hard to pin down," he added.