Link Between Tylenol and Autism in Babies Lacks Evidence, Judge Says

Tylenol, one of the world's most popular over-the-counter painkillers, could be off the hook for major legal action challenging its safety. While nearly 500 lawsuits allege Tylenol can cause autism in babies if mothers take it while pregnant, a judge in Manhattan federal court has denied expert witnesses from testifying in the mass tort lawsuit, effectively stopping the plaintiffs from using scientific studies in their cases. 

Five expert witnesses had been planning to testify in the major case that a mother’s use of acetaminophen, the active ingredient in Tylenol, was linked to childhood autism.

Hundreds of allegations pile up 

Hundreds of lawsuits filed by separate people in 2022 alleged retailers like CVS, Walgreens, and Walmart didn’t warn pregnant women that taking Tylenol could pose neurological risks to their fetuses, including autism and attention deficit hyperactivity disorder. 

In October 2022, the lawsuits were consolidated in front of U.S. District Judge Denise Cote in Manhattan. Cote was also the judge who said in the recent 148-page ruling that the five expert witnesses the plaintiffs had put forward to support their claims lacked strong scientific evidence, Reuters reported.

"Instead, the unstructured approach adopted by the plaintiffs' experts permitted cherry-picking, allowed a results-driven analysis, and obscured the complexities, inconsistencies, and weaknesses in the underlying data," she wrote. 

Unless an appeal is granted, the decision likely spells the end for the lawsuits.

What is acetaminophen?

Acetaminophen is the active ingredient in over-the-counter drug Tylenol, and it is commonly used to treat pain and reduce fever. While there are a range of acetaminophen products created by different brands, the most popular acetaminophen product is Tylenol, owned by Johnson & Johnson spin-off Kenvue. Kenvue lists several warnings for Tylenol usage on its products including:

• Liver damage from overuse
• Allergic reactions
• Drug interactions
• Alcohol interactions
• Risks associated with pregnancy and breastfeeding
• Risks associated with other medical conditions

During pregnancy, a range of aches and pains can arise that lead women to reach for painkillers. While some studies have linked acetaminophen to autism others have said it is safer to take than its counterparts including ibuprofen, which has been linked to fetal organ damage and miscarriage. 

So is Tylenol safe to use while pregnant?

Being pregnant and learning what to limit or avoid altogether is stressful enough without mixed information. Despite what product warnings say or what you might read online, it’s always best to check what is best for you with your healthcare provider, especially if you have specific health concerns. Kenvue said in a statement after the ruling that the lawsuits have created confusion on the safety of “one of the most studied medications in history.” 

“Acetaminophen is recommended by doctors as a first-line treatment option for people who have a fever or are experiencing pain during pregnancy. It is scientifically known that not treating these conditions may have serious health consequences for both mother and baby,” the company said, adding it would be moving to dismiss all the cases. 

If you think you or your baby has been harmed because of medication you took while pregnant, talk to your healthcare provider and a lawyer to find out what you can do.

The Tylenol Autism MDL is In Re: Acetaminophen - ASD/ADHD Products Liability Litigation, MDL No. 3043, in the U.S. District Court for Southern District of New York.