FDA initiates label change on Tylenol to warn of autism
Source: The Hill
09/23/25 5:24 PM ET
The Food and Drug Administration (FDA) announced Monday it has begun the process of changing the labeling on acetaminophen to suggest that it may cause autism and ADHD in children whose mothers took the common pain reliever while pregnant.
The announcement followed President Trump’s announcement from the White House in which he repeatedly told pregnant women, “Don’t take Tylenol.” “Fight like hell not to take it,” said Trump.
Acetaminophen, commonly sold as Tylenol, has been available in the U.S. as an over-the-counter pain reliever and fever reducer for decades. It is one of the few easily available options for pregnant women seeking pain relief. This new guidance from the Trump administration flies in the face of what numerous medical societies and organizations say reflects the current science.
“In more than two decades of research on the use of acetaminophen in pregnancy, not a single reputable study has successfully concluded that the use of acetaminophen in any trimester of pregnancy causes neurodevelopmental disorders in children,” Steven Fleischman, president of the American College of Obstetricians and Gynecologists (ACOG), said in a statement Monday.
Read more: https://thehill.com/policy/healthcare/5518478-tylenol-acetaminophen-pregnancy-risks/
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But the ramifications here are immense if they target that one active ingredient, which is in a billion "combo" products (in addition to "standalone" products). I.e., it's not just tablets, capsules, gelcaps. dissolvable strips, or caplets, but in syrups like cough medicine, in combo with all kinds of other active (and inactive) ingredients!
