WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence, suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children.
The agency also issued a related letter alerting physicians nationwide that the use of Tylenol during pregnancy can lead to a 'very increased risk of autism'.
The move follows President Donald Trump's announcement Monday about what the White House described as 'major progress in understanding the root causes of autism.'
'They are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary,' such as to treat fever, 'if you can't tough it out,' Trump said in the presence of Health and Human Services Secretary Robert F. Kennedy Jr. and top federal health-medical agency officials.
'The Trump Administration does not believe popping more pills is always the answer for better health. There is mounting evidence finding a connection between acetaminophen use during pregnancy and autism - and that's why the Administration is courageously issuing this new health guidance,' White House Press Secretary Karoline Leavitt said in a statement.
After the Trump administration's announcement, UK's Medicines and Healthcare products Regulatory Agency confirmed that taking paracetamol during pregnancy remains safe and there is no evidence it causes autism in children.
Additionally, the Trump Administration is approving a new treatment option that has been found to improve some autism symptoms.
FDA initiated the approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a neurological condition that affects folate (a vitamin essential for brain health) transport into the brain. Individuals with cerebral folate deficiency have been observed to have developmental delays with autistic features (e.g., challenges with social communication, sensory processing, and repetitive behaviors), seizures, and problems with movement and coordination.
'We have witnessed a tragic four-fold increase in autism over two decades,' said FDA Commissioner Marty Makary, M.D., M.P.H. '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.'
The FDA said it is working with GSK, the innovator of Wellcovorin (leucovorin calcium), on a process to include the essential scientific information needed for the safe and effective use of these drug products for adults and pediatric patients with CFD. As the New Drug Application (NDA) holder for this medicine, GSK has preliminarily agreed to work with the FDA on this relabeling effort.
'The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen,' said FDA Commissioner Marty Makary. However, he made it clear that 'Even with this body of evidence, the choice still belongs with parents'. 'The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don't require treatment. It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.'
Copyright(c) 2025 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2025 AFX News
