Tylenol maker opposes possible label change linking painkiller use during pregnancy to autism
Kenvue, the U.S. company that makes Tylenol, says the U.S. Food and Drug Administration should not propose changes to the product’s safety label to reflect research into a possible link between its use during 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 acetaminophen, is “one of the most studied drugs in history” and that “adopting the proposed labeling revisions would be arbitrary, capricious and contrary to law.”
Tylenol generates $1 billion a year for the company and is considered the company’s best-selling brand, according to brokerage firm Morningstar.
The current label instructs pregnant or breastfeeding people to “ask a healthcare practitioner before use.”
The push for a label change came after President Donald Trump held a news conference last month in which he told pregnant women who are suffering to try to “tough it out” instead of taking Tylenol, even though acetaminophen is the only over-the-counter pain reliever considered safe for pregnant women.
The president claimed without evidence that Tylenol use during pregnancy was linked to a “significantly increased risk of autism.”
“Fight like hell not to accept it,” Trump urged.
According to studies, most women use acetaminophen at some point during their pregnancy. Other common treatments for pain or fever, such as regular-dose ibuprofen or aspirin, may increase the risk of serious complications when used during pregnancy.
Untreated pain or fever can be dangerous for the mother and fetus, possibly leading to problems such as miscarriage, birth defects or high blood pressure.
Beginning the process of changing the safety label on acetaminophen products was just one of the steps the Trump administration planned to take.
U.S. Health and Human Services Secretary Robert F. Kennedy Jr. said at last month’s press conference that his agency would launch a public interest campaign on the issue.
The FDA also sent a letter to doctors saying that the choice to take Tylenol “always rests with the parents” but that its use during pregnancy may lead to an “increased risk of neurological conditions such as autism and ADHD in children.”
However, the letter also stated that “a causal relationship has not been established” and that studies of a link are “contradictory.”
The Informed Consent Action Network, an anti-vaccine nonprofit with close ties to Kennedy, said in a letter dated the day of Trump’s news conference that it had filed a citizen petition with the FDA. Such filings are a way for individuals, industry, or consumer groups to ask the agency to take action on a specific issue.
The petition states that because of the “urgent public health implications,” the FDA should act quickly to add a more detailed warning to the labels of over-the-counter drug products containing acetaminophen to clarify that “studies show that frequent use of this product during pregnancy may increase your child’s risk of neurodevelopmental disorders, including autism spectrum disorder and neurodevelopmental deficit disorder.” attention/hyperactivity”.
On Friday, Kenvue asked the FDA to deny the petition, saying the suggested label changes are not supported by scientific evidence “and would represent an unexplained departure from the FDA’s long-standing position on acetaminophen during pregnancy.”
The company said it met with Kennedy in early September, after the HHS secretary told her he believed there was a link between acetaminophen use during pregnancy and autism, and she told him no such link existed.
An HHS spokesperson said Monday that the FDA does not comment on product-specific issues.
The FDA’s website on acetaminophen has not changed to reflect the Trump administration’s views. It says it was last updated in August and states: “To date, the FDA has not found clear evidence that the appropriate use of acetaminophen during pregnancy results in adverse pregnancy, delivery, neurobehavioral, or developmental outcomes.” »
Acetaminophen has been studied for decades to detect problems it might cause during pregnancy, according to the American College of Obstetricians & Gynecologists. No reputable studies have concluded that acetaminophen use during any trimester of pregnancy causes neurodevelopmental disorders in children.
This group points to a study published last year of more than 2 million children that found no significant association between acetaminophen use during pregnancy and the risk of autism, ADHD or intellectual disability in children.
Another study published in August analyzed 46 studies on acetaminophen use during pregnancy and neurodevelopmental disorders. Six of the studies specifically examined acetaminophen use and autism. Overall, the analysis concluded that there was “strong evidence of an association” between acetaminophen use during pregnancy and autism, but the authors were careful to clarify that while the paper could only show an association, the research could not show that acetaminophen caused autism.
“We recommend judicious use of acetaminophen – lowest effective dose, shortest duration – under medical supervision, tailored to individual risk-benefit assessments, rather than broad limitation,” the researchers wrote in that analysis.
After Trump’s press conference, the European Union and United Kingdom drug regulatory agencies and Health Canada quickly issued statements confirming that taking over-the-counter painkillers during pregnancy remains safe.
