In this photographic illustration, Tylenol layers are shown on September 22, 2025 in San Anselmo, California.
Justin Sullivan | Getty images
On Monday, the Trump administration obtained a link not tested between autism and the use of acetaminophen of pregnant women, the active ingredient in one of the most common free sale analgesics in the world, Kenvue'S Tylenol.
President Donald Trump said the food and medication administration will issue a doctor's notice about the risk of patients using acetaminophen during pregnancy unless they have a fever. The agency will also begin the process of changing the security label for acetaminophen in Tylenol and similar products.
The movements face a most of the scientific literature that suggests a causal link between autism and exposure to acetaminophen in the uterus.
Many free sales medications contain acetaminophen, but the tilenol is considered widely the safest treatment during pregnancy to relieve pain and fever, provided that patients use the recommended dose.
“Taking Tylenol is not good,” Trump said during a press conference on Monday. “They strongly recommend that women limit the use of Tylenol during pregnancy unless it is medically necessary. That is, for example, in cases of extremely high fever, that you feel that you cannot resist it, you cannot do it.”
The Department of Health and Human Services will encourage doctors to “exercise their best judgment” about the use of acetaminophen during pregnancy by “prescribing the lowest effective dose with the least necessary duration and only when treatment is required,” said Department Secretary, Robert F. Kennedy Jr.
HHS will launch a national campaign to inform patients about the alleged risk, Kennedy said.
In a statement on Monday, Kenvue said he believes in “independent and solid science” that shows that taking acetaminophen does not cause autism, and “we disagree with any suggestion in another way and we are deeply concerned about the health risk that this poses for expected mothers.” Without the medicine as an option, women can have to experience conditions such as fever that are potentially harmful for both them and their babies, or use more risky alternatives, Kenvue said.
Fever and pain not treated during pregnancy can take risks for both the mother and babies, such as spontaneous abortion, birth defects and high blood pressure, according to the Maternal-Fetal Medicine Society.
The FDA Commissioner Marty Makary suggested that treating a fever “can prolong the duration of the disease in a small child,” citing a study by Johns Hopkins, without further details.
“Perhaps it is because a fever is the natural shape of a body to fight an infection,” Makary said.
Trump, several times during the informative session, said “there is no problem” not to take Tylenol during pregnancy or in the first years of a baby's life.
The FDA erases a less known drug
Also on Monday, the FDA approved a less known medicine, Leucovorin, as a treatment for autism, said the Centers of the Medicare and Medicaid service administrator, Dr. Mehmet Oz, during the informative session.
The agency is specifically updating the Leucovorin label for brain folate deficiency, which HHS said it has been associated with autism. The change will allow children with autism to be treated with the drug, with continuous use if children show language, social or adaptive profits, according to an HHS statement.
But HHS said that Leucovalin is not a cure for autism and can only lead to improvements in speech -related deficits for a subset of children with the disorder. Medicaid state programs may cover the medication for autism after the label update. The NIH will also begin rehearsals to confirm the effects of leucovorine on disorder, including studies on medicine security.
While it is promising, it is important to keep in mind that leucovorina is not a cure for ASD and can only lead to improvements in speech -related deficits for a subset of children with ASD. In addition, this treatment should be administered under close medical supervision and together with other non -pharmacological approaches for children with ASD (for example, behavioral therapy).
Leucovorina is a form of folate, a vitamin B, which is generally prescribed to counteract the side effects of some medications, including chemotherapy and to treat vitamin B9 deficiency. Some first clinical trials with placebo have shown that oral leucovorine, also known as folinic acid, has the potential to improve symptoms in children with autistic spectrum disorder.
The Food and Medicines Administration published a warning on the early Monday saying that a version of Leucovorin is approving that was previously made by GSK, the Wall Street Journal reported. But from Monday afternoon, the Federal Registry website said he received an “agency letter” asking to withdraw the notice.
In a statement, a GSK spokesman said he does not intend to market Leucovorin. The company marketed the drug from 1983 to 1999 under the name of Wellcovorin, but the product was removed from the market and has since been available as a generic medicine. The spokesman said that changes in the label made in Wellcovorin will help allow the genericians who are already in the market to add this new approval for autism to their labeling.
Acetaminophen is the last widely used and accepted treatment that Robert F. Kennedy Jr. has undermined the helm of the Department of Health and Human Services, which supervises federal health agencies that regulate drugs and other therapies. Kennedy has also taken measures to change vaccine policy in the US., And has amplified false claims about safe and effective shots that use RNM technology.
Kennedy has turned autism into a key HHS approach, promising in April that the agency “will know what the autism epidemic has caused” in September and eliminates the exhibitions. He also said that month that the agency has launched a “massive effort of evidence and research” that involves hundreds of scientists worldwide who will determine the cause.
Much of the scientific community agrees that autism results from a complex combination of genetic and environmental factors, which makes it unlikely that the growing rates of the disorder are due to a single cause.
Kennedy said the HHS expects several ads in the coming years to inform parents about the underlying cause of autism and “potential paths for prevention and reversal.” He acknowledged that autism is a complex disorder caused by a combination of factors and said that HHS continues to investigate other factors, such as vaccines.
“An area that we are examining closely … around 40% to 70% of mothers with autism believe that their son was injured by a vaccine,” Kennedy said. “President Trump believes that we should listen to these mothers instead of illuminating gases as previous administrations.”
An extensive investigation has discredited long -standing concerns that vaccines are linked to autism, an affirmation that Kennedy and other immunization critics have driven for several years.
Research on the use of acetaminophen and autism
The Washington Post reported Friday that Trump administration officials have been reviewing previous research that suggests a link between the use of acetaminophen during pregnancy and a higher risk of autism. The post said that it includes an August review conducted by Mount Sinai and Harvard researchers in 46 previous studies that suggest a link between the prenatal exposure to the drug and a greater risk of neurological development disorders, such as autism or the disorder due to hyperactivity, or ADHD care deficit.
The review found that the association is stronger when acetaminophen is taken for four weeks or more, said Dr. Andrea Baccarelli, one of its authors and dean of the Faculty of the Harvard Thard Public Health School of Thard Th Chan, in a statement. The review was funded by a subsidy of the National Health Institutes.
“This biological evidence supports the possibility of a causal relationship between prenatal exposure to acetaminophen and neurological development disorders, including autism,” said Baccarelli, added that more research is needed to “confirm the association and determine causality.”
He said that, according to existing evidence, he believes that “caution on the use of acetaminophen during pregnancy, especially heavy or prolonged use, is justified.” But Baccarelli said that acetaminophen is still a critical tool for pregnant women and their doctors, since drugs is the only medication approved for pain and fever relief during pregnancy.
He said that he and his colleagues recommend a “balanced approach based on the precautionary principle:” Patients who need fever or pain reduction during pregnancy should take the lowest effective dose of the medication during the shortest possible duration, after consulting their doctor about their individual risks and the benefits of doing so. Baccarelli said he discussed that recommendation and the findings of the review with NIH director Jay Bhattacharya and Kennedy, in recent weeks.
The results of the studies reviewed by the researchers They disagree with other solid studies, including one published last year in the Journal of the American Medical Association that found that the consumption of acetaminophen during pregnancy was not related to autism, ADHD or intellectual disability. The researchers analyzed health records of 2.5 million children in Sweden.
When the researchers observed the general population initially, there was a greater risk of disorder in children whose mothers took the drug while they were pregnant. But the researchers did not find a link after comparing brothers within the same family: one exposed to acetaminophen during pregnancy, and the other does not.
Until Monday before the announcement, the FDA website said the agency had not found “clear evidence” that the appropriate use of acetaminophen during pregnancy causes “adverse pregnancy, birth, neuroconductual or development results.” The American College of Obstetricians and Gynecologists maintains that acetaminophen is safe during pregnancy when taken according to the indications and after consulting a medical care provider.
Some parents have brought demand that gave birth to children with autism after using the analgesic.
But a federal judge in Manhattan ruled in 2023 that some of these demands lacked scientific evidence and then ended the litigation in 2024.
– Angelica Peebles de CNBC contributed to this report
