FDA Ignored Its Experts’ Advice on Tylenol Risks for Almost a Decade, Documents Show...

by Michael Tennant at New American

Although the Food and Drug Administration (FDA) only cautioned pregnant women in September against taking excessive amounts of Tylenol because the drug has been linked to autism in children, the agency has in fact known of such links since 2016, the Daily Caller reported Tuesday.

Moreover, the FDA repeatedly refused to update its advice regarding Tylenol despite recommendations from its drug-safety experts that notifying expectant mothers of the potential risks was “needed,” “important,” or “desirable.”

Untriggered Warnings

The Daily Caller News Foundation obtained relevant internal FDA documents from law firm Keller Postman LLC, which got them via a Freedom of Information Act request. Keller Postman is currently appealing a federal court decision in its class-action lawsuit against Kenvue, the company that manufactures the acetaminophen brand Tylenol.

Prior to this year, the only statement the FDA had made on Tylenol was a 2015 announcement that it was “aware of concerns” regarding the popular painkiller. That statement was prompted by a 2014 study published in the Journal of the American Medical Association finding that “maternal acetaminophen use during pregnancy is associated with a higher risk for [hyperkinetic disorders] and ADHD-like behaviors in children.”

In 2016, FDA Senior Medical Officer Andrew Mosholder produced a 22-page report summarizing the results of eight studies, all but one of which found “an association between acetaminophen and issues including attention deficits, delayed motor development and autistic behaviors,” penned the Daily Caller.

Mosholder, the website added,…