U.S. Health and Human Services Secretary Robert F. Kennedy Jr. (RFK Jr.) is preparing to release a report that will link he use of Tylenol during pregnancy, claiming a potential link between the popular pain reliever and autism in children.
The report, first previewed by The Wall Street Journal, has already sent shockwaves through the pharmaceutical and medical communities, and it caused shares of Tylenol maker Kenvue to plunge 14 percent on Friday.
According to individuals familiar with the matter, Kennedy’s forthcoming announcement will suggest that pregnant women who take acetaminophen — the active ingredient in Tylenol — could be increasing the risk of autism in their children.
The report is also expected to highlight research indicating that low folate levels during pregnancy, combined with acetaminophen exposure, may contribute to developmental disorders. In addition, Kennedy plans to argue that a form of folate known as folinic acid may provide treatment options for people already diagnosed with autism.
The Department of Health and Human Services has not yet confirmed or commented on the report. But if released as expected, it will represent one of the most controversial public health statements in years, especially given that acetaminophen is widely considered a safe, first-line treatment for pain and fever in pregnant women.
Kenvue, the consumer health company spun off from Johnson & Johnson and the current maker of Tylenol, quickly issued a rebuttal to the claims. “We believe there is no causal link between Tylenol use during pregnancy and autism,” the company said in a statement. “The U.S. Food and Drug Administration and leading medical organizations agree on the safety of acetaminophen, its use during pregnancy, and the information provided on the label.” The firm urged expectant mothers to consult doctors before taking any over-the-counter medications.
Medical groups have long echoed that position. Acetaminophen has been used for decades by millions of pregnant women worldwide, and while some observational studies have raised questions, no major regulatory agency has concluded that it poses a proven risk of autism or other developmental disorders.
The controversy is not entirely new. In recent years, hundreds of lawsuits were filed in federal court alleging that Tylenol caused autism when used by mothers during pregnancy.
In December 2023, however, those claims were dealt a major setback when a federal judge ruled that the plaintiffs’ expert witnesses failed to present reliable scientific evidence.
The ruling barred those experts from testifying, and by August 2024 the lawsuits were dismissed outright. An appeals court is scheduled to revisit the matter later this year, but the original ruling underscored the legal system’s reluctance to validate such claims without stronger evidence.
Kennedy, who previously led the group Children’s Health Defense, has long been a lightning rod in health policy debates. His organization has repeatedly used social media to highlight studies that suggest potential risks of acetaminophen use in pregnancy.
Supporters argue that Kennedy is simply pushing for caution and more research, while critics accuse him of undermining trust in mainstream medicine by overstating risks.
The new HHS report will likely reignite those tensions. By suggesting that a common, household drug may be linked to a complex neurodevelopmental disorder, Kennedy risks creating confusion among expectant parents, many of whom rely on acetaminophen as one of the few pain relievers considered safe during pregnancy.
Scientific studies on this issue remain inconclusive. A 2023 study suggested a possible association between prenatal acetaminophen use and neurodevelopmental problems, including autism, and recommended that pregnant women use the lowest effective dose for the shortest possible time. Researchers stressed, however, that failing to treat high fever in pregnancy can itself lead to dangerous complications such as neural tube defects.
On the other hand, a large 2024 study published in The Journal of the American Medical Association examined 2.4 million children in Sweden and found no evidence of a causal link between acetaminophen use in pregnancy and autism. Experts caution that autism is a multifactorial condition, influenced by genetics, environment, and other prenatal factors, making it extremely difficult to tie directly to a single drug exposure.
This article was posted originally by Reuters.