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

 The Food and Drug Administration (FDA) has faced criticism for neglecting expert advice regarding the risks of Tylenol (acetaminophen) during pregnancy. Despite knowing about potential links between Tylenol use and developmental issues in children since 2016, the FDA only recently issued a warning about these risks.

1. Delay in Warning:

• The FDA became aware of studies linking Tylenol to autism and other neurological conditions in children back in 2016 but failed to update its advice until September 2025.

• Internal documents reveal that FDA experts recommended warnings as early as 2016, deeming it necessary for public safety.

2. Documented Oversight:

• The information about the FDA’s oversight was obtained by Keller Postman LLC through a Freedom of Information Act request as part of a lawsuit involving Tylenol's manufacturer, Kenvue.

• Prior to this year, the FDA’s only acknowledgment of concerns was a vague 2015 statement.

3. Expert Reports:

• A detailed 22-page report by Andrew Mosholder, an FDA Senior Medical Officer, showed that most studies reviewed indicated a risk of attention deficits and adverse behaviors linked to acetaminophen use during pregnancy.

• FDA’s Pediatric and Maternal Health divisions also supported the necessity of providing clear warnings about Tylenol.

4. Inaction by the FDA:

• In 2018, the FDA's advisory committee delayed endorsing Mosholder's recommended public statement even after reviewing multiple studies indicating risks. Further recommendations to warn the public went ignored.

• Even after a European agency planned to issue a warning, the FDA remained silent on the matter.

5. Continued Research:

• Mosholder conducted additional reviews in 2019 and 2022, reinforcing the concerns associated with Tylenol and its effects on pregnancy, yet the FDA continued to avoid updating its guidelines.

• The latest FDA communication states that while there is a body of evidence linking Tylenol use in pregnancy to neurological risks, the choice regarding its use must ultimately rest with parents.

6. Recent Developments:

• The FDA finally updated its public guidance in September 2025, aligning with longstanding expert recommendations. The new guidance advises that acetaminophen should be used cautiously during pregnancy, emphasizing that it carries risks but may be necessary in specific situations.

• The announcement from FDA Commissioner Marty Makary indicated that while there is considerable evidence of risk, the choice to use Tylenol should still be left to parents.

The FDA’s longstanding inaction on Tylenol risks highlights a gap between scientific evidence and public health communication. After years of expert recommendations to inform pregnant women of potential hazards linked to acetaminophen, the agency has only recently begun to acknowledge these risks publicly. This delay raises concerns about oversight in protecting public health and emphasizes the importance of prompt communication regarding medical safety. 

https://thenewamerican.com/us/healthcare/fda-ignored-its-experts-advice-on-tylenol-risks-for-almost-a-decade-documents-show/