Trump admin draws unproven link between autism and Tylenol ingredient use during pregnancy

The Trump medication connected Monday drew an unproven nexus betwixt autism and large women's usage of acetaminophen, the progressive constituent successful 1 of the world's astir communal over-the-counter symptom relievers, Kenvue's Tylenol.

President Donald Trump said the Food and Drug Administration volition contented a physician's announcement astir the hazard of patients utilizing acetaminophen during gestation unless they person a fever. As portion of a process to alteration the drug's information label, the Health and Human Services Department volition motorboat a nationwide run to pass patients astir the risk.

The proposal clashes with a bulk of technological lit suggesting nary causal nexus betwixt autism and vulnerability to acetaminophen successful the womb. 

Many over-the-counter drugs incorporate acetaminophen, but Tylenol is wide considered the safest treatment to instrumentality during gestation to relieve symptom and fever, arsenic agelong arsenic patients usage the recommended dose. 

"Taking Tylenol is not good," President Donald Trump said during a property league connected Monday. "They are powerfully recommending that women bounds Tylenol usage during gestation unless medically necessary. That's for instance, successful cases of highly precocious fever, that you consciousness you can't pugnacious it out, you can't bash it."

In a connection Monday, Kenvue said it believes successful "independent, dependable science" that shows taking acetaminophen does not origin autism, and "we powerfully disagree with immoderate proposition different and are profoundly acrophobic with the wellness hazard this poses for expecting mothers." Without the cause arsenic an option, women whitethorn person to acquisition conditions similar fever that are perchance harmful to some them and their babies, oregon usage riskier alternatives, Kenvue said.

Untreated fever and symptom during gestation can carry risks for some parent and infant, specified arsenic miscarriage, commencement defects and precocious humor pressure, according to the Society for Maternal-Fetal Medicine.

An earlier study that the medication was investigating the nexus betwixt the cause and autism sent shares of Kenvue sinking. 

Also connected Monday, Trump said the FDA volition beryllium updating the statement of an existing cause to bespeak its imaginable benefits successful reducing immoderate autism symptoms, without disclosing the sanction of the medicine.

"This gives anticipation to the galore parents with autistic children that it whitethorn beryllium imaginable to amended their lives," helium said.

The Washington Post reported Friday that the Trump medication volition tout a lesser-known drug, leucovorin, arsenic a imaginable attraction for symptoms of autism. It is simply a signifier of folate, a B vitamin, that is typically prescribed to counteract immoderate medications' broadside effects, including chemotherapy, and to dainty vitamin B9 deficiency. Some early placebo-controlled objective trials person shown that oral leucovorin, besides known arsenic folinic acid, has the imaginable to amended symptoms successful children with autism spectrum disorder.

The Food and Drug Administration aboriginal Monday published a announcement saying it is approving a mentation of leucovorin that was antecedently made by GSK, the Wall Street Journal reported. But arsenic of Monday afternoon, the Federal Register's website said it has received an "agency letter" asking to retreat the notice.

Acetaminophen is the latest wide utilized and accepted attraction that Robert F. Kennedy Jr. has undermined astatine the helm of the Health and Human Services department, which oversees national wellness agencies that modulate drugs and different therapies. Kennedy has besides taken steps to alteration vaccine argumentation successful the U.S., and has amplified mendacious claims astir harmless and effectual shots that usage mRNA technology.

Kennedy has made autism a cardinal absorption of HHS, pledging successful April that the bureau volition "know what has caused the autism epidemic" by September and destruct exposures. He also said that month that the bureau has launched a "massive investigating and probe effort" involving hundreds of scientists worldwide that volition find the cause.

Much of the technological assemblage agrees that autism results from a analyzable premix of familial and biology factors, making it improbable that rising rates of the upset are owed to a azygous cause.

The Washington Post connected Friday reported that Trump medication officials person been reviewing erstwhile probe that suggests a nexus betwixt the usage of acetaminophen during gestation and an accrued hazard of autism. The Post said that includes an August review by Mount Sinai and Harvard researchers connected 46 earlier studies that suggest a link betwixt prenatal vulnerability to the cause and accrued risks of neurodevelopmental disorders, specified arsenic autism oregon attraction shortage hyperactivity disorder, oregon ADHD. 

The reappraisal recovered the relation is strongest erstwhile acetaminophen is taken for 4 weeks oregon longer, Dr. Andrea Baccarelli, 1 of its authors and dean of the module astatine the Harvard T.H. Chan School of Public Health, said successful a statement. The reappraisal was funded by a assistance from the National Institutes of Health.

"This biologic grounds lends enactment to the anticipation of a causal narration betwixt prenatal acetaminophen vulnerability and neurodevelopmental disorders, including autism," Baccarelli said, adding that further probe is needed to "confirm the relation and find causality."

He said based connected existing evidence, helium believes that "caution astir acetaminophen usage during pregnancy—especially dense oregon prolonged use—is warranted." But Baccarelli said acetaminophen remains a captious instrumentality for large women and their physicians, arsenic the cause is the lone approved medicine for symptom and fever alleviation during pregnancy.

He said helium and his colleagues urge a "balanced attack based connected the precautionary principle:" patients who request fever oregon symptom simplification during gestation should instrumentality the lowest effectual dose of the cause for the shortest imaginable duration, aft consulting their doc astir their idiosyncratic risks and benefits of doing so. Baccarelli said helium discussed that proposal and the review's findings with NIH Director Jay Bhattacharya and Kennedy successful caller weeks.

The findings of the studies reviewed by the researchers are astatine likelihood with different robust studies, including 1 published past twelvemonth successful the Journal of the American Medical Association that recovered acetaminophen usage during gestation was not linked to autism, ADHD oregon intelligence disability. Researchers analyzed wellness records of 2.5 cardinal children successful Sweden.

When researchers looked astatine the wide colonisation initially, determination was a precise tiny accrued hazard of the upset successful children whose mothers took the cause portion pregnant. But researchers recovered nary nexus aft comparing siblings wrong the aforesaid family: 1 exposed to acetaminophen during pregnancy, and the different not.

As of Monday earlier the announcement, the FDA website said the bureau had not recovered "clear evidence" that due usage of acetaminophen during gestation causes "adverse pregnancy, birth, neurobehavioral, oregon developmental outcomes." The American College of Obstetricians and Gynecologists maintains that acetaminophen is safe during gestation erstwhile taken arsenic directed and aft consulting a health-care provider. 

Some parents person brought lawsuits claiming that they gave commencement to children with autism aft utilizing the painkiller.

But a national justice successful Manhattan ruled successful 2023 that some of those lawsuits lacked technological evidence and aboriginal ended the litigation successful 2024.

— CNBC's Angelica Peebles contributed to this report