US EditionFDA initiates label change on Tylenol to warn of autism
The FDA will add warnings to acetaminophen products due to studies linking prenatal use with neurodevelopmental disorders such as autism and ADHD, despite causality not being proven.
- On September 23, 2025, the FDA and the Trump administration announced plans to update acetaminophen labels to warn about possible autism risks during pregnancy.
- The announcement followed growing scientific debate and some studies suggesting correlations, although a large 2024 NIH-funded study found no causal link.
- FDA will issue a physicians’ notice and recommend using the lowest effective acetaminophen dose for the shortest time when medically necessary during pregnancy.
- Health Secretary Robert F. Kennedy stated, "This is about informed decision-making," while President Trump urged, "Ideally, don't take it at all" during pregnancy.
- The update may increase caution but also raises concerns about stigmatizing families since experts emphasize autism's genetic causes and current evidence remains inconclusive.
26 Articles
26 Articles
Government Announcement on Autism Should Revive Lawsuits Over Tylenol: Attorneys
The federal government’s new warning that taking Tylenol during pregnancy may lead to autism should prompt the revival of lawsuits from mothers who allege Tylenol caused their children’s autism or attention-deficit/hyperactivity disorder (ADHD), attorneys for the families said in a new filing. Federal officials on Sept. 22 moved to update labeling for Tylenol and other drugs containing acetaminophen, which are used for pain and fever relief. Reg…
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RFK Jr. wants an answer to rising autism rates. Scientists say he’s ignoring some obvious ones
This week, the Trump administration announced that it was taking “bold action” to address the “epidemic” of autism spectrum disorder — starting with a new safety label on Tylenol and other acetaminophen products that suggests a link to autism. The scientific evidence for doing so is weak, researchers said. Read more...
When was Tylenol invented and sold to the public?
Tylenol is at the top of everyone’s minds today after President Trump announced a label change from the U.S. Food and Drug Administration that states using the medication during pregnancy can lead to a “very increased risk of autism.”
The Food and Drug Administration (FDA) announced that it has begun the process of changing Tylenol labeling in light of President Trump's announcement that acetaminophen is linked to the development of autism when used during pregnancy. “The FDA is taking steps to make parents and physicians aware of the considerable body of evidence regarding the potential risks associated with acetaminophen,” said FDA Commissioner Marty Makary. “Even with this…
‘Whatever They Want Us to Believe’: Holly Robinson Peete Torches Trump and RFK Jr. After Tylenol Autism Claim, Says Families Need Help
Actress Holly Robinson Peete has seen enough misleading claims about autism over the last few months, so when Donald Trump stepped up to a podium this week with his latest medical proclamation, the actress and longtime autism advocate just could not stay silent. With her 27-year-old autistic son RJ as her inspiration and years of advocacy work as her foundation, Peete delivered a measured but firm response to an administration she believes is mi…
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