ICAN Submits Petition to Ensure FDA Changes Acetaminophen Warning Labels Regarding Pregnancy


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On the same day that Secretary Kennedy and President Trump held a press conference announcing evidence that taking acetaminophen (Tylenol) during pregnancy can cause neurodevelopmental issues such autism or ADHD, ICAN submitted a Petition—the result of months of work—to ensure FDA changes the warning labels on every single product that contains acetaminophen.

As our supporters are aware, many parents with autistic children point to vaccines, such as DTaP, Hep B, Hib, PCV13, and IPV—which are all received before the first birthday—as the cause of their children’s autism. The science to support how aluminum adjuvants in vaccines, for example, can cause autism has been laid out by ICAN. However, other factors including drugs can and do play a role, and the case for acetaminophen contributing to autism is strong. We applaud any effort to limit the exposure babies and children have to environmental toxins, including in utero.

ICAN’s petition contains a comprehensive overview of the scientific evidence linking frequent acetaminophen use during pregnancy to fetal neurodevelopmental harm—including over a decade of internal reviews by FDA itself that have not been made public until now. Despite tracking this issue since 2014, FDA chose to do nothing to warn women of this potential harm. Even when the European Medicines Agency (Europe’s FDA) ordered a labeling change in 2019, FDA did its usual—nothing. But finally, under the leadership of Secretary Kennedy and Commissioner Makary, things are changing.

While Secretary Kennedy said the FDA would issue a physician’s notice about the acetaminophen risk and begin the process of a safety label change, ICAN is unwilling to leave anything to chance. Our urgent petition implores FDA to act without delay to change the labels and provide crucial warnings for pregnant women and their care providers.

You can help by adding your support to the petition. Click here to view the petition and add a comment urging the FDA to act quickly. This is a critical step to warn all new pregnant mothers—with every day that passes, more babies are potentially exposed to harm. 

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