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What the research says about Tylenol and autism

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Recent reports in the Washington Post and Wall Street Journal say President Trump and Health Secretary Robert F. Kennedy Jr. are expected to announce that the use of Tylenol by pregnant women may be linked to autism in children. But many top medical experts in the field say the evidence does not support that.

This comes after Kennedy said in April that HHS would undertake a “massive testing and research effort” to determine the cause of autism. Kennedy at the time said the plan was to release a comprehensive report in September. However, National Institutes of Health Director Dr. Jay Bhattacharya said later that month the findings could take up to a year.

Kennedy has in the past made the unfounded claim that autism is a “preventable disease,” drawing heavy criticism from many medical experts, who say evidence shows there are multiple factors, including genetics, that play a role.

In a statement provided to CBS News on Sept. 5, an HHS spokesperson said, “We are using gold-standard science to get to the bottom of America’s unprecedented rise in autism rates. Until we release the final report, any claims about its contents are nothing more than speculation.”

What does Tylenol maker Kenvue say about autism?

In response to the WSJ story on Sept. 5, Kenvue, the maker of Tylenol — whose active ingredient is acetaminophen — said: “We have continuously evaluated the science and continue to believe there is no causal link between acetaminophen use during pregnancy and autism. To date, the U.S. Food and Drug Administration (FDA) and leading medical organizations agree on the safety of acetaminophen, its use during pregnancy, and the information provided on the label.”

Kenvue added, “We appreciate the Secretary acknowledging media coverage on the upcoming HHS report is ‘nothing more than speculation.'”

In another statement on Sept. 21, the company said:

“We believe independent, sound science clearly shows that taking 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.

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.

The facts are that over a decade of rigorous research, endorsed by leading medical professionals and global health regulators, confirms there is no credible evidence linking acetaminophen to autism. We stand with the many public health and medical professionals who have reviewed this science and agree. We will continue to explore all options to protect the health interests of American women and children.”

What do medical experts say?

The American College of Obstetricians and Gynecologists said in a statement provided to CBS News that “there is no clear evidence that proves a direct relationship between the prudent use of acetaminophen during pregnancy and fetal developmental issues.”

“Neurodevelopmental disorders, in particular, are multifactorial and very difficult to associate with a singular cause,” ACOG said. “Pregnant patients should not be frightened away from the many benefits of acetaminophen, which is safe and one of the few options pregnant people have for pain relief.”

Dr. Christopher Zahn, ACOG’s chief of clinical practice, said, “Pregnant patients should not be frightened away from the many benefits of acetaminophen, which is safe and one of the few options pregnant people have for pain relief.”

“If you have a high fever during pregnancy, that can cause neurodevelopment issues in the baby, so you don’t want to let that fever go untreated,” said Dr. Céline Goudner, CBS News medical contributor and editor-at-large for public health at KFF Health News. She said pregnant women should talk with their OB-GYN, especially if they’re needing it frequently, and use the lowest effective dose for the shortest time.

While some research suggested there could be a possible association between acetaminophen use and neurodevelopmental disorders, those studies involved relatively small groups and did not prove a link. Larger and more robust studies have found no connection between acetaminophen and autism.

“I spoke this afternoon to a researcher who was part of a major study published just last year that followed 2.5 million children in Sweden over 25 years,” CBS News chief medical correspondent Dr. Jon LaPook said after the WSJ report came out. “He said use of acetaminophen … was not associated with an increased risk of autism in children.”

LaPook said he is looking forward to reading the upcoming report pledged by Kennedy, “especially the evidence behind any conclusions and recommendations.”

Autism has become more prevalent in children born in the U.S. over the past 25 years, according to statistics compiled by the U.S. Centers for Disease Control and Prevention. But there is no scientific consensus on the reasons why.

Research shows the causes of autism “are complex,” Dr. Christine Ladd-Acosta, an associate professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health and the vice director for the Wendy Klag Center for Autism and Developmental Disabilities, told CBS News in an interview.

“There have been a few dozen studies looking at Tylenol and whether use during pregnancy is associated with risk of autism in those women’s children, and the evidence has been really kind of conflicting,” Ladd-Acosta said. “Some studies have shown no association. Some have shown a positive association. Some have shown negative associations. And I think part of that is because it’s really hard to tease apart … whether it’s the medication itself that is influencing autism risk in the child, or if it has to do with the condition … the mother is using the medicine to treat that is the thing that is important in autism risk.”

Ladd-Acosta noted that the dosage, the length of time that pregnant women take Tylenol, and the “specific condition” they are taking it for are all factors that have been considered when attempting to determine if there is a potential association between the medication and autism.

“There have been some associations, but there has been no conclusive evidence I’ve seen to show that Tylenol itself causes autism definitively,” Ladd-Acosta said.

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