Physicians and health organizations are reassuring patients that acetaminophen is safe to use during pregnancy after President Donald Trump said on Monday that the FDA will notify doctors that using the drug during gestation can be associated with a “very increased risk of autism.” 

Critics were quick to denounce the administration’s assertions, reassure patients, and point to decades of evidence contradicting Trump’s claims. 

Linking use of acetaminophen during pregnancy to autism is “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,” said Steven J. Fleischman, MD, MBA, president of the American College of Obstetricians and Gynecologists (ACOG), in a statement.

He said acetaminophen is one of the few options available to pregnant patients for pain and fever that can harm pregnant women and their fetuses if untreated. 

Between 40% and 65% of pregnant women use acetaminophen, but rates may be higher among women who have high-risk pregnancies. A study of those with autoimmune disorders found 74% used acetaminophen during gestation; some evidence suggests the offspring of fathers and mothers with autoimmune conditions such as rheumatoid arthritis are at increased risk for neurodevelopmental disorders, including autism. 

Some point to research, including a recent Mount Sinai School of Medicine study showing a link between acetaminophen and autism, but the findings did not establish causality. Instead, the outcomes showed an association but did not account for other possible factors, such as genetics. Fever itself can cause neurodevelopmental issues in children. Other studies show that the drug is unlikely to increase risk for childhood asthma or neonatal cardiovascular issues. 

Fleischman said in his statement that two high-quality studies on the use of acetaminophen in pregnancy found no statistically significant associations with offspring’s risk for autism or intellectual disability. 

A spokesperson for the Society for Maternal-Fetal Medicine said use of acetaminophen during pregnancy has not been shown to cause or increase the risk for autism or other neurobehavioral problems in children and that the drug is an appropriate medication for pain. 

Alternatives Carry Restrictions, Contraindications

The only pharmacologic alternatives to acetaminophen are nonsteroidal anti-inflammatory drugs such as ibuprofen, said Eve Espey, MD, MPH, distinguished professor in the Department of Obstetrics and Gynecology at the University of New Mexico in Albuquerque. 

These medications carry risks based on time of gestation, including potential malformations with use in the first trimester, potential negative impact on fetal renal dysfunction in the second trimester, and an absolute contraindication in the third trimester due to concerns for premature closure of the ductus arteriosus in the fetus. 

She said patients have contacted her asking what to believe with the announcement from the Trump Administration. 

Espey said she continues to recommend that appropriate patients take Tylenol for pain and fever In line with 2021 ACOG guidelines which have not changed. 

“Any medication taken during pregnancy should be used only as needed, in moderation, and after the pregnant patient has consulted with their doctor,” Espey said. 

“The wasted resources that the government is spending to fan skepticism on this safe medication would be better spent on women’s health research including conditions related to pregnancy, said Catherine Cansino, MD, MPH, clinical professor of obstetrics and gynecology at the University of California, Davis Health, in Sacramento. 

The European Medicines Association (EMA) also weighed in Tuesday on the controversy. 

Acetaminophen, known as paracetamol in Europe, “remains an important option to treat pain or fever in pregnant women,” said Steffen Thirstrup, MD, PhD, the EMA’s chief medical officer, in a statement. 

Cansino and Espey declared no relevant financial relationships.