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 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 Informed Consent Action Network, represented by Siri & Glimstad LLP, supports the proposed action. They argue that a new study on rodent models provides biologically plausible evidence of developmental neurotoxicity from in utero acetaminophen exposure, justifying a precautionary warning during pregnancy.

Americans for Scientific Integrity is submitting a supplemental comment to support the Informed Consent Action Network's petition regarding acetaminophen use during pregnancy. They argue that a new peer-reviewed study on rodent neurotoxicity provides evidence of biological plausibility for the petition's request for precautionary labeling.

Kenvue Brands LLC opposes the proposed labeling changes for over-the-counter acetaminophen products, arguing that the scientific evidence linking prenatal use to neurodevelopmental disorders is unreliable and methodologically flawed. The company contends that the requested warnings would be misleading, violate the First Amendment, and contradict the FDA's evidence-driven regulatory framework.

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.

The Society for Developmental and Behavioral Pediatrics opposes the proposed FDA labeling change for over-the-counter acetaminophen. They argue that there is no strong evidence linking appropriate acetaminophen use during pregnancy to an increased risk of autism or ADHD, citing studies that suggest genetics and maternal health are more likely factors.

The Organization for Latino Health Advocacy opposes the proposed label change for acetaminophen during pregnancy. They argue that the product label should remain based on the full body of scientific and medical literature and emphasize that pregnant patients should not have to suffer unnecessary pain.

LNK International, Inc., a generic pharmaceutical manufacturer, opposes the proposed labeling changes for acetaminophen-containing products. They argue that the current warning statement is sufficient, the proposed changes lack scientific evidence, and that implementing them would be burdensome and confusing for consumers and manufacturers.