Kenvue, the company behind Tylenol, is opposing proposed changes to its product labels, calling them “inappropriate.” This response comes after the Informed Consent Action Network urged the FDA to modify Tylenol’s labeling to warn pregnant women and their caregivers about potential risks linked to autism. This push was sparked by comments from the Trump administration that connected Tylenol use during pregnancy to autism.
Is there any evidence of risk?
Kenvue asserted that the proposed changes lack scientific backing. In their response to the petition, the company stated that altering the labels for over-the-counter acetaminophen products is “legally and procedurally inappropriate.” They emphasized that consumer warnings about supposed risks between acetaminophen use and neurodevelopmental disorders contradict a substantial amount of evidence disproving such claims.
Additionally, Kenvue described acetaminophen as one of the “most studied drugs in history,” noting that the FDA has continuously reviewed its safety for more than a decade. They maintain that current evidence does not establish a causal link between its use during pregnancy and disorders like ASD or ADHD.
Billion dollar brand
Tylenol is reportedly Kenvue’s best-selling brand, generating around $1 billion annually. If the FDA approves the changes suggested by ICAN, the labels would be updated to include specific warnings. Currently, the label states to “consult a health care professional before use” if pregnant or breastfeeding.
Back in September, former President Trump raised concerns about Tylenol use in pregnancy potentially significantly increasing autism risk, urging caution against its use.
New autism treatment
Meanwhile, the FDA is moving forward with new treatments for autism-related symptoms. Just recently, they announced the approval of leucovorin calcium tablets for those with “cerebral folate deficiency,” a condition related to neurological issues impacting folate transport to the brain. This deficiency has been linked to developmental delays exhibiting features of autism.
FDA Commissioner Marty McCulley remarked on the alarming rise in autism cases over the last two decades, emphasizing that children suffering from autism deserve access to effective treatments. The FDA’s approach relies on standard science and common sense to serve public needs.
Leucovorin is known to carry some side effects, albeit rare, which include skin rash, wheezing, and in some cases, seizures.
