Executive Summary
- President Trump announced the FDA would notify physicians about a purported link between acetaminophen use during pregnancy and an increased risk of autism, and advocated for significant changes to childhood vaccination schedules, claims that contradict scientific evidence.
- Medical experts and the Tylenol manufacturer affirm the safety of acetaminophen for pregnant women, while the FDA’s messaging indicates no causal relationship has been established between acetaminophen and autism, contrary to Trump’s definitive claims.
- The rise in autism diagnoses is attributed to broadened definitions and increased awareness, and the FDA has approved prescription leucovorin as a new treatment for autistic children.
The Story So Far
- President Donald Trump’s recent statements regarding purported links between acetaminophen use during pregnancy and autism, and his advocacy for changes to childhood vaccination schedules, contradict decades of scientific evidence affirming their safety. These claims align with the views of prominent anti-vaccine activist Robert F. Kennedy Jr., whom Trump publicly acknowledged for bringing autism into political discourse, and they emerge amidst a rise in autism diagnoses that experts attribute to factors like broadened definitions and increased awareness rather than new environmental causes.
Why This Matters
- President Trump’s public statements, which contradict established scientific consensus on acetaminophen use during pregnancy and childhood vaccination schedules, risk sowing widespread public confusion and could lead pregnant individuals to avoid safe, medically recommended treatments, potentially jeopardizing maternal and fetal health, despite the FDA’s more nuanced messaging emphasizing the lack of established causal links; separately, the FDA’s approval of leucovorin for autistic children signals emerging therapeutic options for managing certain autism-related conditions.
Who Thinks What?
- President Donald Trump announced a purported link between acetaminophen use during pregnancy and increased autism risk, advocating for the FDA to notify physicians and recommend limiting Tylenol use, and also suggested delaying childhood vaccinations like the hepatitis B shot, despite scientific evidence to the contrary.
- The scientific community, medical experts, and Tylenol manufacturer Kenvue maintain that there is no credible evidence linking acetaminophen to autism, emphasizing its safety for pregnant women and the dangers of untreated fever, and similarly state that extensive research disproves a connection between vaccines and autism.
- FDA and HHS officials, while present at Trump’s announcement, offered a more moderate perspective, with an FDA letter stating that “a causal relationship has not been established” between Tylenol and autism, and acknowledging “contrary studies,” while planning a public service campaign to inform families.
President Donald Trump announced Monday that the U.S. Food and Drug Administration (FDA) would be notifying physicians about a purported link between acetaminophen use during pregnancy and an increased risk of autism, a claim that contradicts decades of scientific evidence affirming its safety. Speaking from the Oval Office, Trump also advocated for significant changes to childhood vaccination schedules, including delaying the hepatitis B shot for newborns until age 12, despite extensive research disproving a connection between vaccines and autism.
Acetaminophen and Autism Claims
Trump stated that the FDA would “strongly recommend” women limit Tylenol use during pregnancy unless medically necessary, such as to treat a fever. This advice comes despite acetaminophen being widely considered the only safe over-the-counter option for pain and fever for pregnant individuals, as other common pain relievers like ibuprofen or regular-dose aspirin can pose serious risks during pregnancy. Experts emphasize that not treating a fever can also be dangerous for both the fetus and the pregnant person.
The Tylenol manufacturer, Kenvue, reiterated its stance on the drug’s safety for pregnant women. The company stated that over a decade of rigorous research, endorsed by leading medical professionals and global health regulators, confirms no credible evidence links acetaminophen to autism. Kenvue urged pregnant women to consult their healthcare providers before taking any over-the-counter medication.
Expert Consensus and FDA Nuance
While President Trump presented a definitive link, the scientific community holds that autism is caused by multiple factors, and the connection between acetaminophen use during pregnancy and autism is not settled. Dr. Peter Hotez, a pediatrician and co-director of the Center for Vaccine Development at Texas Children’s Hospital, highlighted that at least 100 genes are involved in autism, making it unlikely a single chemical agent could cause or cure the condition. He described claims of a “smoking gun” for autism as irresponsible.
The messaging from the FDA and the Department of Health and Human Services (HHS) officials present at the announcement was notably more moderate than Trump’s remarks. An FDA letter to physicians, as cited by HHS Secretary Robert F. Kennedy Jr., states that “a causal relationship has not been established” between Tylenol and autism and acknowledges “contrary studies in the scientific literature.” Kennedy also indicated that HHS would launch a public service campaign to inform families and encourage clinicians to use their best judgment regarding acetaminophen use during pregnancy.
Vaccine-Related Discussions
Beyond acetaminophen, Trump used the platform to advocate for breaking up childhood vaccinations, claiming “too much liquid, too many different things are going into that baby” without providing evidence. He specifically suggested pushing back the hepatitis B shot for newborns, a strategy credited with bringing the infection in children to near elimination, to age 12. Extensive research consistently shows no link between vaccines and autism.
Trump publicly thanked Kennedy for bringing autism to the “forefront of American politics, along with me.” Kennedy, a prominent anti-vaccine activist, has previously promoted discredited theories linking vaccines to autism.
Autism Diagnosis and New Treatments
The number of children diagnosed with autism spectrum disorder has been on the rise, with about 1 in 31 children diagnosed by age 8 in 2022, up from 1 in 68 in 2015. Experts attribute this increase to several factors, including a broadened definition of autism by the psychiatric community in 2013, increased awareness of symptoms, greater acceptance of the diagnosis, and concerted efforts to screen more young children for early intervention.
In a separate development, Dr. Mehmet Oz, Administrator for the Centers for Medicare & Medicaid Services, announced that the FDA is approving prescription leucovorin—a high-dose calcium folinic acid typically used in cancer treatment—for autistic children. The FDA is also restoring the previously withdrawn approval of Wellcovorin, a branded version of leucovorin by GSK, and has asked GSK to file a new application to include data on cerebral folate deficiency (CFD), a condition characterized by low folate levels in cerebrospinal fluid.
