President Donald Trump on Sept. 22 announced a government effort tying acetaminophen (Tylenol) use during pregnancy to autism and other neurodevelopmental conditions and urged people to avoid the drug.
The announcement — which also promoted the vitamin derivative leucovorin as a possible treatment for some autism symptoms and questioned childhood vaccine schedules — drew immediate pushback from major medical groups and autism researchers.
What the White House said
The U.S. Department of Health and Human Services and the Food and Drug Administration said recent studies show an association between prenatal acetaminophen exposure and later diagnoses of autism or ADHD, and the FDA said it has begun the process to change acetaminophen labeling and notified clinicians of the evidence.
In the FDA news release, Commissioner Marty Makary said, “The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen.”
The agency also emphasized that a causal link has not been established and that acetaminophen is the only over-the-counter drug approved to treat fever in pregnancy.
Responses from the medical field
Obstetric and maternal-fetal medicine societies and autism research organizations uniformly urged caution about drawing firm conclusions from the existing research.
The American College of Obstetricians and Gynecologists (ACOG) said, “Suggestions that acetaminophen use in pregnancy causes autism are not only highly concerning to clinicians but also irresponsible when considering the harmful and confusing message they send to pregnant patients, including those who may need to rely on this beneficial medicine during pregnancy.”
ACOG noted that the highest-quality studies to date did not find a significant association and urged that acetaminophen remain available as a treatment for fever and pain during pregnancy.
The Society for Maternal-Fetal Medicine (SMFM) echoed that stance, saying, “In response to today’s White House press conference announcement, the Society for Maternal-Fetal Medicine reiterates its recommendation advising both physicians and patients that acetaminophen is an appropriate medication to treat pain and fever during pregnancy.”
SMFM added that reviews of the research have not established causation.
Autism researchers and advocacy groups warned that the announcement oversimplified complex science.
“Any association between acetaminophen and autism is based on limited, conflicting, and inconsistent science and is premature,” said Dr. Alycia Halladay, chief science officer for the Autism Science Foundation.
The group called the White House claims “dangerous” and said the studies available have limits which may confound the reasons women take acetaminophen (for example, fever) and genetic or maternal health factors.
What the science shows
Research over the past decade has produced mixed findings. Some cohort studies have reported small associations between prenatal acetaminophen and later neurodevelopmental differences. At the same time, higher-quality designs that control for family and genetic factors — including a sibling analysis published in JAMA — found no significant association. Experts emphasize that most observational studies cannot prove cause and effect; confounding factors such as fever, infection, and underlying maternal conditions complicate interpretation.
What this means for pregnant people and parents
Doctors and national bodies stress that pregnant people should not stop or start medications based on a single public announcement. ACOG and SMFM advise discussing any medication use with a health care provider and using acetaminophen “as needed, in moderation, and after consultation with a doctor,” particularly because high fever in pregnancy can harm both pregnant people and fetuses. The FDA press release similarly noted it “remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.”
Practical guidance doctors give now
- If you are pregnant or trying to become pregnant, talk to your obstetrician, midwife or primary care clinician before changing how you treat pain or fever. ACOG recommends consulting a clinician about appropriate use.
- Do not abruptly stop treating a high fever without medical advice; an untreated high fever can harm pregnancy. Acetaminophen is currently the recommended over-the-counter option for fever in pregnancy; alternatives such as ibuprofen and aspirin have known risks in specific trimesters.
- If you take acetaminophen regularly or chronically during pregnancy, raise that with your clinician so they can weigh the benefits and risks for your particular situation. The FDA noted that some studies suggest that any risk may be greater with chronic use.
Bottom line
Experts say the existing science does not prove that ordinary, occasional use of acetaminophen in pregnancy causes autism. The FDA’s decision to review labeling reflects concern about associations reported in multiple observational studies. Still, leading obstetric and maternal-fetal medicine organizations caution that the evidence is inconsistent and that fever and pain management remain essential. Pregnant people should not make medication decisions based solely on political statements; instead, speak with a trusted clinician about the safest option for you.
This reporting is made possible by a grant from the Indianapolis African-American Quality of Life Initiative, empowering our community with essential health insights. https://iaaqli.org/
Contact Health & Environmental Reporter Hanna Rauworth at 317-762-7854 or follow her on Instagram at @hanna.rauworth.
Hanna Rauworth is the Health & Environmental Reporter for the Indianapolis Recorder Newspaper, where she covers topics at the intersection of public health, environmental issues, and community impact. With a commitment to storytelling that informs and empowers, she strives to highlight the challenges and solutions shaping the well-being of Indianapolis residents.
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