Citizen Petition from Siri & Glimstad LLP on behalf of Informed Consent Action Network

The Informed Consent Action Network supports the request for a precautionary principle warning regarding acetaminophen use during pregnancy and labor. They provide a book as a comprehensive index of scientific literature to help the FDA identify and contextualize evidence regarding acetaminophen's potential neurodevelopmental risks.

The commenter is submitting a peer-reviewed study by Tamaki et al. (2024) to support the requested acetaminophen warning. They argue that the study demonstrates unexpectedly high mammary transfer of acetaminophen into breast milk, necessitating expanded warning language for the full perinatal exposure window.

The commenter provides a scientific article from the Journal of Physiology to support the need for a prenatal warning regarding acetaminophen use. They argue that the drug crosses the fetal blood-brain barrier and that prolonged exposure may pose a neurodevelopmental risk to the fetus.

The commenter provides a scientific review from The Journal of Physiology to support a petition regarding prenatal acetaminophen safety. They argue that because acetaminophen readily crosses the placenta and enters the fetal brain, pregnant women should receive clear warning language and informed-consent guidance.

The Informed Consent Action Network (ICAN) argues that sibling-control analyses in prenatal neurodevelopment research are often unstable and potentially biased, and therefore should not be used to dismiss potential risks from prenatal acetaminophen. They advocate for the FDA to weigh these studies alongside other evidence to justify a precautionary prenatal warning.

Americans for Scientific Integrity (AFSI) argues that the FDA should consolidate the review of two separate petitions regarding acetaminophen safety because the metabolic vulnerabilities of fetuses and infants are biologically continuous. They also request that the FDA mandate a precautionary warning on OTC acetaminophen labels for children due to reported associations with asthma, allergies, and eczema.

The Protecting Access to Pain Relief (PAPR) Coalition, a group of 16 national public health organizations, opposes the proposed labeling changes for over-the-counter acetaminophen. They argue that the proposed warnings are not grounded in robust evidence and could restrict access to a vital medication for vulnerable populations who cannot safely take NSAIDs.