Trump connects to the acetaminophen autism of the Tylenols ingredients during pregnancy

The Trump administration established an unproven link on Monday between autism and use by pregnant women of acetaminophen, the active ingredient in one of the most common over the Up -free analgesics in the world, Kenvue‘s tylenol.

President Donald Trump said Food and Drug Administration would publish a doctor’s opinion on the risk that patients use acetaminophen during pregnancy unless they have a fever. The agency will also start the process of modifying the security label of acetaminophen on tylenol and similar products.

The movements clash with most of the scientific literature not suggesting any causal link between autism and exposure to acetaminophen in the uterus.

Many over -the -counter drugs contain acetaminophen, but tylenol is widely considered as the surest treatment during pregnancy to relieve pain and fever, as long as patients use the recommended dose.

“Taking Tylenol is not good,” Trump said at a press conference on Monday. “They strongly recommend that women limit the use of Tylenol during pregnancy, unless medically necessary. It is for example, in case of extremely high fever, that you think you cannot finish it, you cannot do it.”

The Department of Health and Social Services will encourage clinicians to “exercise their best judgment” around the use of acetaminophen during pregnancy by “prescribing the lowest effective dose with the shortest necessary duration and only when the treatment is necessary,” said the secretary of the department, Robert F. Kennedy Jr., during the press situation.

HHS will launch a national campaign to inform patients of the alleged risk, said Kennedy.

In a statement on Monday, Kenvue said that he believed that he believed in “an independent and solid science” which shows that the taking of acetaminophen does not cause autism, and “we do not agree with a suggestion otherwise and we are deeply concerned about the risk to the health that this poses for the expectations of mothers”. Without the drug as an option, women may have conditions such as fever that are potentially harmful to them and their babies, or use more risky alternatives, Kenvue said.

Untreated fever and pain during pregnancy may include risks for the mother and infants, such as miscarriage, congenital malformations and high blood pressure, according to the Society for Materal-Fetal Medicine.

The FDA commissioner, Marty Makary, suggested that the treatment of a fever “can prolong the duration of the disease in a young child”, citing a study by Johns Hopkins, without more details.

“It may be because a fever is the natural way of a body to get rid of an infection,” said Makary.

Trump, several times during the briefing, said “there is no drawback” so as not to take Tylenol during pregnancy or at the start of a baby.

Also on Monday, the FDA approved a less known medication, Leucovorine, as an autism treatment, said Dr. Mehmet Oz, administrator of the Medicare & Medicaid services, during the briefing.

The agency specifically puts the update of the Leucovorin label for a brain deficiency in folate, which, according to HHS, was associated with autism. The change will allow autistic children to be treated with the drug, with continuous use if children have language, social or adaptive gains, according to a press release from the HHS.

But HHS said Leucuvorine is not a remedy for autism and can only lead to improvements in the words related to speech for a subset of children with disorder. Medicaid state programs will be able to cover the drug for autism after updating the label. The National Institutes of Health will also start trials to confirm the effects of Leucuvorine on disorder, including studies on drug safety.

Leucuvorine is a form of folate, a vitamin B, which is generally prescribed to counter the side effects of certain drugs, including chemotherapy, and to treat vitamin B9 deficiency. Certain clinical trials controlled by the first placebo have shown that oral leucuvorine, also known as folinic acid, has the potential to improve symptoms in children with autistic spectrum disorder.

The Food and Drug Administration published on Monday an opinion indicating that he approves a version of Leucovorin which had already been made by GSK, reported the Wall Street Journal. But Monday afternoon, the Federal Register website said it had received an “agency letter” asking to withdraw the opinion.

In a statement, a GSK spokesperson said that he did not intend to market Leucovorine. The company marketed the drug from 1983 to 1999 under the name of Wellcovorin, but the product has been withdrawn from the market and has since been available as a generic drug. The spokesperson said that the label changes made to Wellcovorin will help allow the generics on the market to add this new approval for autism to their labeling.

Acetaminophen is the latest treatment widely used and accepted that Kennedy has undermined the department of health and social services, which oversees federal health agencies that regulate drugs and other therapies. Kennedy has also taken measures to modify vaccine policy in the United States and has amplified false claims on safe and effective shots that use mRNA technology.

Kennedy made autism a key objective of the HHS, engaging in April that the agency “knows what caused the autism epidemic” by September and will eliminate exhibitions. He also said this month that the agency had launched a “massive test and research effort” involving hundreds of scientists around the world who will determine the cause.

A large part of the scientific community applies that autism results from a complex mixture of genetic and environmental factors, which makes it unlikely that the increase in disorder rates is due to a single cause.

Kennedy said HHS expects several announcements in the coming years that inform parents of the underlying cause of autism and “potential paths of prevention and inversion”. He recognized that autism is a complex disorder caused by a combination of factors and said that HHS continues to study other factors such as vaccines.

“An area that we examine closely … about 40% to 70% of autistic mothers believe that his child was injured by a vaccine,” said Kennedy. “President Trump believes that we should listen to these mothers instead of gas lighting and previous administrations.”

In -depth research has demystified the long -standing concerns that vaccines are linked to autism, an assertion that Kennedy and other vaccination criticisms have pushed for several years.

The Washington Post reported on Friday that Trump administration officials examined previous research that suggests a link between the use of acetaminophen during pregnancy and an increased risk of autism. The post said that this includes a August Sinai review and Harvard researchers on 46 previous studies that suggest a link between prenatal exposure to drugs and increased risks of neurodevelopmental disorders, such as autism or hyperactivity disorder of attention deficit, or ADDH.

The journal revealed that the association is strongest when the acetaminophen is taken for four weeks or more, Dr. Andrea Baccarelli, one of his authors and dean of the Harvard Th Cha Cha Chan of Public Health, in a press release. The exam was funded by a subsidy of the National Institutes of Health.

“These biological evidence confirms the possibility of a causal relationship between prenatal exposure to acetaminophen and neurodevelopmental disorders, including autism,” said Baccarelli, adding that additional research is necessary to “confirm the association and determine causation”.

He said that on the basis of existing evidence, he believes that “caution concerning the use of acetaminophen during pregnancy – in particular heavy or prolonged use – is justified”. But Baccarelli said acetaminophen remains a critical tool for pregnant women and their doctors, as medication is the only drug 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 dose of the drug for the shortest possible duration, after consulting their doctor on their individual risks and advantages to do so. Baccarelli said that he had discussed this recommendation and the journal’s conclusions with NIH Director Jay Bhattacharya and Kennedy in recent weeks.

The results of the studies examined by researchers In contradiction with other robust studies, including one published last year in the Journal of the American Medical Association which revealed that the use of acetaminophen during pregnancy was not linked to autism, ADHD or intellectual disability. The researchers analyzed the health files of 2.5 million children in Sweden.

When the researchers first examined the general population, there was a very low increased risk of disorder in children whose mothers took the medication during pregnancy. But the researchers found no link after having compared the brothers and sisters within the same family: one presentation to acetaminophen during pregnancy, and the other no.

Monday before the announcement, the FDA website said that the agency had not found “clear evidence” that the appropriate use of acetaminophen during pregnancy caused “an unfavorable pregnancy, birth, neuro -savio -navio or development results”. The American College of Obstetricians and Gynecologists argues that acetaminophen is safe during pregnancy when taken as indicated and after consulting a health care provider.

Some parents brought prosecution by claiming to have given birth to autistic children after using the pain relievers.

But a Federal Judge of Manhattan judged in 2023 that some of these proceedings lacked scientific evidence and put more at the end of the dispute in 2024.

– Angelica Peebles of CNBC contributed to this report.