Experts say no proven link between prenatal Tylenol use and autism

Elizabeth Concordia, President and Chief Executive Officer at UCHealth Memorial Hospital
Elizabeth Concordia, President and Chief Executive Officer at UCHealth Memorial Hospital - UCHealth Memorial Hospital
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Researchers have found no evidence that taking acetaminophen, also known as Tylenol or paracetamol, during pregnancy causes autism spectrum disorder in children. Acetaminophen is commonly used by pregnant women for pain and fever because alternatives like ibuprofen and opioids carry higher risks during pregnancy.

Despite a recent suggestion from the Trump Administration on September 22 about a possible link between acetaminophen use in pregnancy and autism, many medical experts disagree with this position. The U.S. Food and Drug Administration is currently considering a safety-label recommendation advising pregnant women to avoid acetaminophen.

Dr. Jennifer Braverman, a maternal fetal medicine specialist at UCHealth Maternal Fetal Medicine Clinic – Anschutz Medical Campus and associate professor at the University of Colorado School of Medicine, expressed her disagreement with the administration’s stance. “The best-available data do not support this recommendation,” said Braverman.

Major organizations such as the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and medication-safety authorities in the European Union, United Kingdom, and Australia share Braverman’s view. Recent peer-reviewed studies back their opinion. A study published in August in the Journal of the American Medical Association examined 2.5 million Swedish children and found no relationship between maternal acetaminophen use and autism. Another Japanese study involving 217,000 children reported similar findings.

Some studies have observed an association between acetaminophen use during pregnancy and autism but have not established causation. A review led by Harvard researchers concluded that children exposed to acetaminophen in utero had a higher risk of developing autism than those who were not exposed; however, this does not prove that acetaminophen causes autism.

Autism has multiple known risk factors including genetics, parental age (especially older fathers), air pollution, low birth weight, gestational diabetes, maternal obesity, and infections during pregnancy. Boys are about three times more likely to be diagnosed with autism than girls; younger siblings of autistic children also face increased risk.

Braverman pointed out that earlier studies suggesting a potential link often did not consider why pregnant individuals took Tylenol. “It is possible that fever, inflammation, or infection, rather than acetaminophen use itself, led to the association seen in these small studies between acetaminophen exposure and autism,” she said.

Untreated fevers pose significant risks during pregnancy. Braverman emphasized that high temperatures can lead to birth defects such as cleft lip or palate in early pregnancy and increase chances of miscarriage or preterm birth later on. “Fever has been associated with a lot of problems for babies,” she said. She cautioned against avoiding treatment or turning to less safe medications like ibuprofen or opioids: “And what I worry about in particular is that people are either going to not treat fever, which we know is dangerous for fetuses, or that people are going to turn toward medications that we know are unsafe in pregnancy.”

Braverman considers acetaminophen “the safest option we have” for managing pain or fever during pregnancy.

Dr. James Burton, transplant hepatologist at UCHealth Hepatology Clinic – Anschutz Medical Campus and professor at the University of Colorado School of Medicine, agrees with Braverman’s assessment regarding safety concerns around acetaminophen use even outside pregnancy contexts. He noted it requires extremely high doses—far above recommended amounts—to cause acute liver damage: “Tylenol is safe to take even if you have cirrhosis, and we recommend Tylenol or acetaminophen to our patients on our transplant list.” Burton added: “It’s actually safer than taking ibuprofen in people with chronic liver disease because ibuprofen can cause kidney dysfunction and it can cause gastrointestinal bleeding.”

Braverman advised caution but reassured patients about using necessary medication: “I tell my patients whether you’re pregnant or not you shouldn’t take a medicine for no reason,” she said. “If you have a fever if you have pain we know that Tylenol is a safe and effective treatment for those things—and there aren’t a lot of other options that are safe or effective in pregnancy.”



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