The news: The FDA is starting the process of changing labels for Tylenol and similar products containing acetaminophen. The new label would warn that using acetaminophen during pregnancy might be linked to a higher risk of autism and ADHD in children. For context, acetaminophen is found in more than 600 different prescription and over-the-counter (OTC) medications.

Catch up quick: HHS Secretary Robert F. Kennedy Jr. and other government officials are intent on figuring out what’s driving rising autism rates, particularly in children. Most health experts attribute the increase to improved screening and broader diagnostic criteria, but some federal healthcare leaders believe certain vaccines and products containing acetaminophen are possible causes.

President Trump warned during a Monday press conference, “If you’re pregnant, don’t take Tylenol.” Alongside Trump at Monday’s presser, Kennedy and FDA Commissioner Marty Makary, MD, also made comments connecting autism to Tylenol use by pregnant women.

Tylenol is generally considered the safest and most recommended OTC pain relief option for pregnant patients. Even the FDA’s notice to doctors acknowledged this. While some smaller studies have hinted at a link between autism and Tylenol use among pregnant women, causality remains unproven due to a lack of clear evidence. Several medical and public health organizations have released statements following Monday’s presser that current evidence does not prove a causal link.

Why it matters: Trump’s unsubstantiated medical advice on Monday and the FDA’s updated guidance on acetaminophen will likely cause concern among not only pregnant women, but also families trying to conceive, and mothers of young children who took Tylenol while pregnant.

More people are going to ask their doctors and conduct research on whether other products that contain acetaminophen are safe to take during pregnancy.

• Acetaminophen is the most common drug ingredient in the US, used in products to treat coughs, colds, and allergies, as well as to relieve pain and reduce fevers. For many of these medicines, acetaminophen is used in combination with other active ingredients.
• Each week, approximately 23% of US adults use an acetaminophen-containing medicine, according to the Consumer Healthcare Products Association.

Our take: We’ve previously explored how Tylenol maker Kenvue will be affected by the government linking autism to acetaminophen use by pregnant women. But there are brands and marketers across many other health products and categories that must be prepared to address forthcoming consumer angst.

Marketers of medicines that contain acetaminophen (even if it’s not the main ingredient) should follow Kenvue’s lead by addressing misleading claims on product or brand websites while linking to credible health resources where consumers can find additional guidance from medical experts.

Marketers in this space will also want to be transparent in ads and promotional materials that their medicine contains acetaminophen since consumers are far less familiar with ingredients than prescription drug brands. Campaigns should avoid using language overstating the certainty that acetaminophen isn’t linked to autism and re-emphasize that pregnant women should always consult their doctors before taking the medicine.

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