The Trump administration has thrust Tylenol into the spotlight this week with its warnings about a potential link to autism when taken by pregnant women.
However, the actual guidance coming from the administration is more nuanced than President Trump’s repeated “don’t take Tylenol” urgings at a Tuesday press conference.
And major health groups continue to say Tylenol is safe, arguing the president’s warnings are not backed by science.
Talk to your doctor; take lowest effective dose
Despite Trump’s alarmist comments Tuesday, the administration continues to recommend acetaminophen, the active ingredient in Tylenol, in some cases.
“It remains reasonable,” Food and Drug Administration (FDA) Commissioner Marty Makary said in a statement, “for pregnant women to use acetaminophen in certain scenarios.”
Mehmet Oz, head of the Centers for Medicare and Medicaid Services, said pregnant women should call their doctors when experiencing fevers, which can cause birth defects.
“The doctor’s almost certainly going to prescribe you something, Tylenol might be one of the things they give, that’s not the problem,” Oz told TMZ.
“Pregnant women know lots of the typical things you would take for aches and pains and fevers are not a permissible product to be used during pregnancy,” he added. “Acetaminophen is probably your best option, but take it when you really need it.”
Oz said the bigger issue was pregnant women taking acetaminophen for minor issues like a headache or stubbed toe.
The administration has repeatedly pointed to a study released earlier this year by Mt. Sinai Hospital and Harvard’s T.H. Chan School of Public Health, which found an association between Tylenol and some neurological conditions in children.
But the authors were cautious about any sweeping changes to medical guidance.
“We recommend judicious acetaminophen use—lowest effective dose, shortest duration—under medical guidance, tailored to individual risk-benefit assessments, rather than a broad limitation,” they wrote.
CNN chief medical correspondent Dr. Sanjay Gupta said that tracks with standard medical practice.
“I think most doctors have long said that treating a fever during pregnancy is important and that you should use the lowest dose for the shortest amount of time,” he said.
What the studies say about acetaminophen-autism link
While the Mt. Sinai study has been the main justification for the administration’s warning, the FDA’s statement on its label change to Tylenol admitted the data remains uncertain.
“It is important to note that while an association between acetaminophen and neurological conditions has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature,” it said. “It is also noted that acetaminophen is the only over-the-counter drug approved for use to treat fevers during pregnancy, and high fevers in pregnant women can pose a risk to their children.”
The study also cautioned against drawing any hard conclusions, calling instead for more research and increased caution about Tylenol use.
“Further research is needed to confirm the association and determine causality, but based on existing evidence, I believe that caution about acetaminophen use during pregnancy—especially heavy or prolonged use—is warranted,” Andrea Baccarelli, a professor of environmental health at Harvard, said in a statement.
Another study in Sweden released last year looked at nearly 200,000 children and found no evidence of links between acetaminophen and autism.
“Acetaminophen use during pregnancy was not associated with children’s risk of autism, ADHD, or intellectual disability in sibling control analysis. This suggests that associations observed in other models may have been attributable to familial confounding,” the study found.
Familial confounding refers to when a shared factor between family members, such as genetics or environment, creates a misleading association between inputs and outcomes.
A 2019 Johns Hopkins University study analyzed umbilical cord blood samples, finding that “newborns with the highest exposure to acetaminophen were about three times more likely to be diagnosed with ADHD or autism spectrum disorder in childhood.”
However, authors of that study also cautioned against drawing conclusions based on association, saying “more studies are clearly needed to further clarify the concern.”
Gupta said the “paradox of ubiquity” helped explain the continued scientific uncertainty despite the studies showing association.
“When something is really commonly used in society, it is hard to figure out if it’s associated with something in particular,” Gupta said. “Because people who are taking Tylenol, they may have had fevers, could the fever have something to do with this? Could there have been something else going on? There are a lot of controls you have to do, and it’s hard with something as ubiquitous or common as Tylenol.”
Balancing risk of fever
Women’s health experts worry that the Trump administration’s warnings will cause women to be overly concerned about taking acetaminophen, exposing their babies to other health risks.
“Acetaminophen is one of the few options available to pregnant patients to treat pain and fever, which can be harmful to pregnant people when left untreated,” the American College of Obstetricians and Gynecologists (ACOG) said in a statement this week. “Maternal fever, headaches as an early sign of preeclampsia, and pain are all managed with the therapeutic use of acetaminophen, making acetaminophen essential to the people who need it.”
“The conditions people use acetaminophen to treat during pregnancy are far more dangerous than any theoretical risks and can create severe morbidity and mortality for the pregnant person and the fetus,” it added. “When considering the use of medication in pregnancy, it’s important to consider all potential risks along with any benefits.”
KFF Health News and Politifact gave Trump a “pants on fire” rating over his claim that there is “no downside” to not taking acetaminophen during pregnancy.
It pointed to a Society for Maternal-Fetal Medicine statement that said, “Untreated fever, particularly in the first trimester, increases the risk of miscarriage, birth defects, and premature birth, and untreated pain can lead to maternal depression, anxiety, and high blood pressure.”
