Tylenol’s maker pushes back against possible label change linking pain reliever’s use in pregnancy to autism – CTV
October 20, 2025
Kenvue, the American company that makes Tylenol, says the U.S. Food and Drug Administration should not make proposed changes to the product’s safety label to reflect research about a possible connection between its use in pregnancy and diagnoses of autism or ADHD in children.
Kenvue says that acetaminophen, the generic name for the painkiller and fever reducer also known as paracetamol, is “one of the most studied medicines in history” and that “adoption of the proposed labelling revisions would be arbitrary, capricious, and contrary to law.”
Tylenol generates US$1 billion annually for the company and is considered the company’s biggest-selling brand, according to the brokerage Morningstar.
The current label instructs people who are pregnant or breastfeeding to “ask a health professional before use.”
The push for a label change came after U.S. President Donald Trump held a news conference last month in which he told pregnant women who are in pain to try to “tough it out” instead of taking Tylenol, even though acetaminophen is the one over-the-counter pain reliever considered safe for pregnant people to take.
