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White House links Tylenol in pregnancy to autism; experts say evidence falls short

President Trump announced new FDA guidance suggesting a link between Tylenol use during pregnancy and autism, sparking debate among experts and drugmakers.

White House links Tylenol in pregnancy to autism; experts say evidence falls short

President Trump announced new FDA guidance suggesting a link between Tylenol use during pregnancy and autism, sparking debate among experts and drugmakers.

Washington News Bureau logo
Updated: 5:06 PM CDT Sep 22, 2025
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White House links Tylenol in pregnancy to autism; experts say evidence falls short

President Trump announced new FDA guidance suggesting a link between Tylenol use during pregnancy and autism, sparking debate among experts and drugmakers.

Washington News Bureau logo
Updated: 5:06 PM CDT Sep 22, 2025
Editorial Standards
President Donald Trump announced today that the FDA will notify doctors about a potential link between acetaminophen use during pregnancy and an increased risk of autism, citing a "meteoric rise" in autism rates, now affecting 1 in 31 children.The announcement suggests that women should limit their use of acetaminophen, more commonly known as Tylenol, during pregnancy unless medically necessary, such as in cases of extremely high fever. Meanwhile, the drugmaker Kenvue, which owns Tylenol, strongly refuted the claim, stating, "We believe independent, sound science clearly shows that taking acetaminophen does not cause autism."Brian Lee, a professor of epidemiology at Drexel University, said, "I'm not sure we've quite reached that point on slamming the door shut with acetaminophen, but at this current moment, there is a lot of strong evidence that points away from a causal effect." Lee, who helped conduct the largest study on the link between Tylenol and autism, explained, "So eating ice cream is associated with drowning, but it's not causal, because hot weather causes someone to eat ice cream and hot weather causes someone to go swimming, increasing the risk of drowning. So the association does not mean causation."Dr. Alycia Halladay of the Autism Science Foundation warned that the new guidance could cause confusion and give false hope to parents trying to avoid autism. "You might be giving parents the false sense of comfort to think that they're doing everything they can to stop their child from having autism," she said. "When you know that this is something that is multifactorial and it's very complex."Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists (ACOG), advised, "I think it's really important that before you do anything or get nervous, call your physician, have a conversation." "Today’s announcement by HHS is not backed by the full body of scientific evidence and dangerously simplifies the many and complex causes of neurologic challenges in children," said ACOG in a statement released after the announcement. "It is highly unsettling that our federal health agencies are willing to make an announcement that will affect the health and well-being of millions of people without the backing of reliable data. In more than two decades of research on the use of acetaminophen in pregnancy, not a single reputable study has successfully concluded that the use of acetaminophen in any trimester of pregnancy causes neurodevelopmental disorders in children. In fact, the two highest-quality studies on this subject—one of which was published in JAMA last year—found no significant associations between use of acetaminophen during pregnancy and children’s risk of autism, ADHD, or intellectual disability."The announcement by the Department of Health and Human Services is criticized for not being backed by the full body of scientific evidence, with experts emphasizing that autism is primarily rooted in genetics, and environmental factors can interact with genetic risk. Factors such as paternal age, preterm birth, or maternal health issues during pregnancy are known to play a role. The Johns Hopkins Bloomberg School of Public Health notes that changes in diagnostic criteria and increased screening at wellness visits are major contributors to the rise in autism rates.

President Donald Trump announced today that the FDA will notify doctors about a potential link between acetaminophen use during pregnancy and an increased risk of autism, citing a "meteoric rise" in autism rates, now affecting 1 in 31 children.

The announcement suggests that women should limit their use of acetaminophen, more commonly known as Tylenol, during pregnancy unless medically necessary, such as in cases of extremely high fever.

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Meanwhile, the drugmaker Kenvue, which owns Tylenol, strongly refuted the claim, stating, "We believe independent, sound science clearly shows that taking acetaminophen does not cause autism."

Brian Lee, a professor of epidemiology at Drexel University, said, "I'm not sure we've quite reached that point on slamming the door shut with acetaminophen, but at this current moment, there is a lot of strong evidence that points away from a causal effect."

Lee, who helped conduct the largest study on the link between Tylenol and autism, explained, "So eating ice cream is associated with drowning, but it's not causal, because hot weather causes someone to eat ice cream and hot weather causes someone to go swimming, increasing the risk of drowning. So the association does not mean causation."

Dr. Alycia Halladay of the Autism Science Foundation warned that the new guidance could cause confusion and give false hope to parents trying to avoid autism.

"You might be giving parents the false sense of comfort to think that they're doing everything they can to stop their child from having autism," she said. "When you know that this is something that is multifactorial and it's very complex."

Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists (ACOG), advised, "I think it's really important that before you do anything or get nervous, call your physician, have a conversation."

"Today’s announcement by HHS is not backed by the full body of scientific evidence and dangerously simplifies the many and complex causes of neurologic challenges in children," said ACOG in a statement released after the announcement. "It is highly unsettling that our federal health agencies are willing to make an announcement that will affect the health and well-being of millions of people without the backing of reliable data. In more than two decades of research on the use of acetaminophen in pregnancy, not a single reputable study has successfully concluded that the use of acetaminophen in any trimester of pregnancy causes neurodevelopmental disorders in children. In fact, the two highest-quality studies on this subject—one of which last year—found no significant associations between use of acetaminophen during pregnancy and children’s risk of autism, ADHD, or intellectual disability."

The announcement by the Department of Health and Human Services is criticized for not being backed by the full body of scientific evidence, with experts emphasizing that autism is primarily rooted in genetics, and environmental factors can interact with genetic risk. Factors such as paternal age, preterm birth, or maternal health issues during pregnancy are known to play a role.

The Johns Hopkins Bloomberg School of Public Health notes that changes in diagnostic criteria and increased screening at wellness visits are major contributors to the rise in autism rates.

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