Tylenol Autism Warnings Challenged by J&J Spinoff Kenvue

Drug maker indicates FDA should reject proposed pregnancy warnings for acetaminophen pain killers, indicating there is no link between Tylenol and autism.

The makers of Tylenol are urging federal regulators to reject proposed label warnings that link acetaminophen use during pregnancy to an increased risk of autism and other neurological disorders, arguing the claims are not supported by credible science.

Last month, the U.S. Food and Drug Administration (FDA) announced plans to update warning labels on all acetaminophen-containing medications, including Tylenol, that would require manufacturers to add new language cautioning against use during pregnancy and advised doctors to minimize prescribing the pain reliever to pregnant patients due to potential risks to fetal brain development.

Acetaminophen has been one of the most widely used painkillers in the United States for decades. Originally approved in 1951 and marketed as Tylenol beginning in 1955, the drug quickly became a household staple and remains an active ingredient in hundreds of over-the-counter cold, flu and combination pain medications.

However, a number of studies in recent years have found associations between Tylenol use during pregnancy and an increased risk of autism and attention-deficit hyperactivity disorder (ADHD).

In response to this scientific research, a growing number of complaints have been filed throughout the federal court system, prompting the U.S. Judicial Panel on Multidistrict Litigation (JPML) to centralize all federal Tylenol autism lawsuits before Judge Denise Cote in the Southern District of New York in October 2022, forming MDL No. 3043 to coordinate discovery and expert challenges.

In December 2023, Judge Cote issued a sweeping order excluding all of the plaintiffs’ expert witnesses under the federal Daubert standard, determining that the scientific methods used to link acetaminophen to autism were not reliable enough to present to a jury. As a result, the entire MDL was dismissed before any bellwether trials could take place.

That decision is now under active appeal before the Second Circuit Court of Appeals, and the landscape has shifted dramatically. Plaintiffs argue that the FDA’s new national warning requirement and HHS’s decision to fund autism risk research directly validate the very scientific concerns that drug makers previously argued were speculative.

Following the FDA’s announcement last month to update the Tylenol warning labels, plaintiffs now say that the agency’s decision to provide warning labels means that the scientific evidence is good enough by federal regulator standards and therefore must be good enough for the courts.

Kenvue Calls for Tylenol Petition Rejection

On the same day as the agency’s announcement, a citizens’ petition (PDF) was filed by the Informed Consent Action Network, laying out what they believe should be the language on Tylenol labels. 

The proposed language urges pregnant or breastfeeding women to use the lowest effective dose for the shortest duration possible due to the potential health risks. The petition also calls for the labels to warn the drugs have been associated with neurodevelopmental disorders.

However, in a comment submitted by Kenvue, which is the former Johnson & Johnson consumer health division that has been spun off into its own company, the Tylenol manufacturer challenged that such label warnings have no basis in scientific fact.

“The Citizen Petition requests changes to the labeling of over-the-counter acetaminophen products for use during pregnancy that are unsupported by the scientific evidence and legally and procedurally improper—including requesting that the consumer-facing warning address a risk of acetaminophen use and neurodevelopmental disorders even though the overwhelming weight of the evidence contradicts the existence of any such risk.”

– Kenvue Brands LLC

The company claims that the lack of scientific evidence makes the proposed language an “overwarning,” saying that existing language calling for pregnant women to consult with their physician is enough. The manufacturer also argued that adopting the proposed language changes would be “arbitrary and capricious” and would violate the Administrative Procedure Act.

The comment requests that the agency deny the citizen’s petition because the proposed warning labels would mislead consumers about the medication’s true risks.

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