Tylenol fights autism claims, slams proposed FDA warning label as 'unsupported' by science

The maker of Tylenol is fighting back against proposed changes to its label.

Kenvue, the American company behind Tylenol, says changes proposed by a recent petition would be "improper."

'Fight like hell not to take it.'

After the Trump administration linked the use of Tylenol during pregnancy to autism, the Informed Consent Action Network urged the FDA to "change the labels" for Tylenol and provide "crucial warnings for pregnant women and their care providers."

No evidence for risk?

Kenvue responded directly to the petition in its own document and said that changing the labeling to its over-the-counter acetaminophen products in such a manner would be "unsupported by the scientific evidence and legally and procedurally improper."

Requesting that the consumer-facing warning addresses a risk between "acetaminophen use and neurodevelopmental disorders" would allegedly go against the "overwhelming weight of the evidence contradicts the existence of any such risk," Kenvue claimed.

The manufacturer called acetaminophen one of the "most studied medicines in history," with evidence regarding its use during pregnancy being "continuously evaluated by the FDA for more than a decade."

It further claimed that available evidence does not support "a causal association between acetaminophen use in pregnancy and neurodevelopmental disorders, including ASD and ADHD."

RELATED: Tylenol's concerns about possible autism risk date back more than a decade, documents reportedly show

Billion-dollar brand

CNN reported that Tylenol generates about $1 billion annually for Kenvue and is considered to be its top-selling brand.

If the FDA agrees with ICAN's demand, Tylenol labels would need to be updated from its current instructions that say, "If pregnant or breast-feeding, ask a health professional before use."

President Trump had previously said during a press conference in September that if used during pregnancy, Tylenol was linked to a "very increased risk of autism."

"Fight like hell not to take it," Trump added.

RELATED: 'TrumpRx' website to offer discounted drugs as part of landmark Big Pharma deal

Photo by Jordan Bank/NWSL via Getty Images

New autism drug

At the same time, the U.S. Food and Drug Administration had begun its process to approve a treatment for autism-related symptoms.

The FDA announced in late September that it had approved leucovorin calcium tablets for patients with "cerebral folate deficiency."

The neurological condition affects folate transfer into the brain, the FDA said, adding that "individuals with cerebral folate deficiency have been observed to have developmental delays with autistic features."

"We have witnessed a tragic four-fold increase in autism over two decades," said FDA Commissioner Marty Makary. "Children are suffering and deserve access to potential treatments that have shown promise. We are using gold standard science and common sense to deliver for the American people."

According to the Mayo Clinic, leucovorin has a few side effects, all of which are listed as rare. These include skin rash, hives or itching, and wheezing. "Convulsions (seizures)" are also listed.

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