Major medical groups and medical experts are urging women to continue taking Tylenol as needed during pregnancy, citing the health risks caused by fever during pregnancy.
Medical groups always encourage women to consult with their doctor before taking any new medication during pregnancy, but continue to emphasize that acetaminophen, best known by the brand name Tylenol, is the safest painkiller throughout pregnancy.
Both the American College of Obstetricians and Gynecologists, the nation’s leading membership organization for OB-GYNs, and the Society for Maternal-Fetal Medicine, a 6,500-member organization focused on high-risk pregnancy care, issued statements in support of the use of Tylenol during pregnancy in the wake of claims by from the Trump administration Monday that the use of Tylenol during pregnancy may be linked to an increased risk of autism and guidance that pregnant women should limit their use.
In a note to physicians on Monday evening, the U.S. Food and Drug Administration (FDA) said there was a plausible link between maternal use and autism — a claim that medical groups say lacks sufficient evidence. But the FDA also qualified that there’s no concrete proof Tylenol use during pregnancy causes autism, and ultimately encouraged conversations between doctors and patients.
In remarks at the White House Monday announcing the new guidance, President Donald Trump went further, at times directly urging women to not take Tylenol, encouraging them instead to “tough it out.”
“Don’t take Tylenol. There’s no downside. Don’t take it,” Trump said, standing alongside his top health officials.
“You’ll be uncomfortable,” he added. “It won’t be as easy, maybe. But don’t take it if you’re pregnant. Don’t take Tylenol, and don’t give it to the baby after the baby is born.”
Kenvue, the maker of Tylenol, said in a statement Sunday that it believes research shows that acetaminophen does not cause autism.
“We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers,” the statement read. “Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy. Without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives.”
According to the U.S. Centers for Disease Control and Prevention, a fever of 100.4 F or higher during pregnancy is considered an “urgent maternal warning” sign that requires immediate medical attention.
Fever during pregnancy, especially during the first trimester, has been associated with adverse outcomes including preterm birth, birth defects, miscarriage and high blood pressure, according to groups including the CDC and the March of Dimes, a nonprofit organization focused on improving the health of pregnant people and babies.
For decades, the medical guidance for women has been to take small doses of Tylenol, under a doctor’s supervision, to treat fever and pain during pregnancy, guidance that medical experts are continuing to recommend.
“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,” Dr. Steven J. Fleischman, president of ACOG, said in a statement Monday. “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.”
He added that “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.”
“When considering the use of medication in pregnancy, it’s important to consider all potential risks along with any benefits,” Fleischman said. “The data from numerous studies have shown that acetaminophen plays an important — and safe — role in the well-being of pregnant women.”
In a separate statement, SMFM said it will continue to advise doctors and patients that “acetaminophen is an appropriate medication to treat pain and fever during pregnancy.”
“To be clear, SMFM stands behind our recommendation that acetaminophen use during pregnancy has not been shown to cause or increase the risk of autism or other neurobehavioral problems in children,” the organization said Monday.
Both SMFM and ACOG also said in their respective statements that medical evidence has not found a conclusive link between the use of Tylenol during pregnancy and an increased risk of autism and attention deficit and hyperactivity disorder, or ADHD, in children.
Dr. Paul A. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told ABC News Monday that he believes it is “dangerous misinformation” to advise pregnant women against taking Tylenol when medically necessary.
“I think there is no clear, solid link between a mother taking Tylenol during pregnancy and delivering a child who eventually develops autism,” Offit said. “If you have fever, especially high fever in the first trimester of pregnancy, that can lead to developmental problems for the child, so it’s important to treat with Tylenol, especially in the first trimester of pregnancy. So in that sense, I think this was dangerous misinformation.”
Autism spectrum disorder, or ASD, is a developmental disability caused by differences in the brain, according to the CDC. ADHD is a developmental disorder that, according to the CDC, is “one of the most common neurodevelopmental disorders of childhood.”
In its note to physicians on Monday evening, the FDA said the association is an ongoing area of scientific debate.
“To be clear, while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature,” the note read. “The association is an ongoing area of scientific debate and clinicians should be aware of the issue in their clinical decision-making.”
ABC News chief medical correspondent Dr. Tara Narula, a board-certified cardiologist, said that pregnant women should consult with their doctors for guidance.
“This is a very nuanced discussion. It’s not as simple as ‘Don’t take Tylenol,’ I think, as we heard the president say,” Narula said Tuesday on “Good Morning America.”
She added, “Women should really be speaking to their doctors at this point about making an informed, individualized decision.”