President Donald Trump and members of his Cabinet are slated to announce on Monday afternoon a link between Tylenol use during pregnancy and autism diagnoses, leaving patients concerned about their options to treat fever and pain during pregnancy.
The announcement comes as a culmination of the long-term goal of Health and Human Services Secretary Robert F. Kennedy Jr., who promised in the spring that his department would identify environmental factors that have led to an explosion of autism spectrum disorder diagnoses in the past 30 years.
Recommended Stories
- Trump administration to warn against using Tylenol due to autism risk
- CDC panel votes to drop blanket recommendation for COVID-19 vaccines
- CDC vaccine panel postpones decision on newborn hepatitis B vaccine
In the spring, the Centers for Disease Control and Prevention reported that the rate of autism diagnoses in 8-year-olds across the country had reached 1 in 31, up from 1 in 150 in the early 2000s.
The Wall Street Journal reported earlier this month that the administration was looking at acetaminophen, the active ingredient in Tylenol and several other over-the-counter medications that treat pain, such as DayQuil and Alka-Seltzer.
Trump announced Sunday evening during his speech at the memorial for Charlie Kirk, the conservative activist fatally shot earlier this month, that there would be “one of the biggest announcements … medically, I think, in the history of our country.”
Acetaminophen has been widely regarded for decades as one of the only safe pain and fever-reducing medications to use during pregnancy, as ibuprofen and other classes of painkillers can cause birth defects and miscarriage.
Here is everything to know in advance of Monday’s announcement.
Is acetaminophen safe during pregnancy?
Studying acetaminophen use during pregnancy is fraught with ethical and technical challenges that make it difficult for scientists to prove a causal effect between acetaminophen and autism spectrum disorder or other neurodevelopmental conditions, such as attention-deficit/hyperactivity disorder.
In August, the journal Environmental Health published a meta-review analyzing existing literature and found that the majority of studies included in their analysis “reported positive associations of prenatal acetaminophen use with ADHD, ASD, or [neurodevelopmental disorders] in offspring.”
The authors of the meta-review recommended that “appropriate and immediate steps should be taken to advise pregnant women to limit acetaminophen consumption to protect their offspring’s neurodevelopment.”
Prior to the August study, however, the research has been quite mixed, with many physicians saying the data do not support a causal relationship.
Dr. Salena Zanotti, a Cleveland Clinic OB-GYN, said in March, following a 2024 study on acetaminophen during pregnancy, that it should be considered safe in minimal doses but that pregnant women should discuss all medications with their healthcare providers.
Zanotti also said acetaminophen is safer for an unborn infant than leaving conditions such as fever and severe pain untreated.
“Acetaminophen is still the safest known drug to take during pregnancy for problems like fever and pain,” Zanotti said. “When you’re pregnant, it’s riskier to have an untreated fever than it is to take acetaminophen.”
The American College of Obstetricians and Gynecologists issued a statement in 2021 on acetaminophen use during pregnancy outlining that the scientific studies have not proven a causally direct relationship “between the prudent use of acetaminophen during any trimester and fetal developmental issues.”
“Most importantly, patients should not be frightened away from the many benefits of acetaminophen,” the ACOG’s 2021 statement reads. “However, as always, any medication taken during pregnancy should be used only as needed, in moderation, and after the pregnant patient has consulted with their doctor.”
The ACOG did not respond to the Washington Examiner’s request for a more recent statement.
What do the medical professional organizations say?
The Society for Maternal-Fetal Medicine press release on the subject in early September said that they continue “to advise physicians and patients that acetaminophen is an appropriate medication to treat pain and fever during pregnancy.”
Untreated fevers during pregnancy carry their own risks, especially during the first trimester, the group says. Those risks include miscarriage, birth defects, and premature birth.
Existing research highlights a “potential link between acetaminophen use during pregnancy and an increased risk of autism and attention deficit and hyperactivity disorders,” according to the SMFM, but no studies have been able to determine a causal link.
The group’s president, Dr. Sindhu Srinivas, said in the press release that its recommendations are based on “evaluation of rigorous research and data, clinical expertise, and our patients’ values and preferences.”
“At this time, the weight of scientific evidence that acetaminophen use during pregnancy causes an increased risk for autism or ADHD is simply inconclusive,” Srinivas said.
What other options are there?
Acetaminophen has been considered one of the safest pain relievers for fever, headache, and joint or muscle pain during pregnancy, as other medications have been linked to severe birth defects and higher miscarriage rates.
Nonsteroidal anti-inflammatory drugs, such as ibuprofen, naproxen, and aspirin, have been found in several studies to increase miscarriage risk, particularly in early pregnancy. NSAIDs during the last trimester are also linked to high fetal blood pressure and low amniotic fluid levels, and can make it harder to go into labor.
Many women experience migraine headaches during pregnancy as well, with migraines affecting upward of 20% of women during early pregnancy, according to the Children’s Hospital of Philadelphia.
The ACOG recommends NSAIDs for migraine headaches only if they do not get better with acetaminophen and that NSAIDs be reserved only for the second trimester and only for less than 48 hours at a time.
There are also prescription headache medications that are available for headaches or migraines early in pregnancy.
What else is going to be discussed at the autism briefing?
Multiple outlets have reported that Trump and Kennedy will highlight a medication, leucovorin, that has shown early promise in alleviating certain symptoms associated with autism, including cognition and communication skills.
Leucovorin is the brand name for folinic acid, a form of folic acid, which is an essential B vitamin. Folate, also known as folic acid, is an essential nutrient for neurological development during early pregnancy.
The medication in the form of leucovorin is most commonly paired with the chemotherapy drug methotrexate to preserve healthy cells from the toxic effects of cancer treatment.
Tightly controlled early-stage clinical trials have shown that leucovorin may boost communication and cognition for some people with autism.
TRUMP ADMINISTRATION TO WARN AGAINST USING TYLENOL DUE TO AUTISM RISK
Researchers studying autism have found that some people with ASD have difficulty transporting the nutrient folate to the brain. Trial results have shown that leucovorin could improve the delivery mechanism of the nutrient for people with autism.
The same report from earlier this month that speculated Tylenol would be the main feature of the highly anticipated autism announcement also indicated that Kennedy and his team were examining the role of folate intake during pregnancy and the development of autism and other neurodevelopmental problems, including ADHD.