Tylenol’s maker pushes back against possible label change linking pain reliever’s use in pregnancy to autism
By Jen Christensen, CNN
(CNN) — Kenvue, the American company that makes Tylenol, says the US 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 labeling revisions would be arbitrary, capricious, and contrary to law.”
Tylenol generates $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 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.
The president claimed without evidence that Tylenol use during pregnancy was linked to a “very increased risk of autism.”
“Fight like hell not to take it,” Trump urged.
Most people use acetaminophen at some point during their pregnancy, studies show. Other common pain or fever treatments like ibuprofen or regular-dose aspirin can increase the risk of serious complications when used during pregnancy.
Untreated pain or fever can be dangerous for the mother and the fetus, possibly leading to problems like miscarriage, birth defects or high blood pressure.
Beginning the process to change the safety label on acetaminophen products was just one action the Trump administration planned to take.
US Health and Human Services Secretary Robert F. Kennedy Jr. said at the news conference last month that his agency would launch a public service campaign about the issue.
The FDA also sent a letter to physicians saying that the choice to take Tylenol “still belongs with parents” but that use during pregnancy may cause an “increased risk of neurological conditions such as autism and ADHD in children.”
However, the letter also noted that “a causal relationship has not been established” and that studies about a link are “contradictory.”
The Informed Consent Action Network, an anti-vaccine nonprofit with close ties Kennedy, said in a letter dated the day of Trump’s news conference that it had filed a citizen’s 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 says 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 that contain acetaminophen to spell out 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 attention-deficit/hyperactivity disorder.”
On Friday, Kenvue asked the FDA to deny the petition, saying that suggested changes to the label are unsupported by scientific evidence “and would represent an unexplained departure from FDA’s longstanding position on acetaminophen during pregnancy.”
The company said it met with Kennedy in early September, after the HHS secretary reached out to say he believed there was a connection between acetaminophen use during pregnancy and autism, and it told him there was no such link.
The FDA website on acetaminophen has not changed to reflect the Trump administration’s views. It says it was last updated in August and specifies, “to date, FDA has not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes.”
Acetaminophen has been studied for decades to find any problems it may cause in pregnancy, according to the American College of Obstetricians & Gynecologists. Not one reputable study has concluded that acetaminophen use in any trimester of pregnancy causes neurodevelopmental disorders in children.
That group points to a study published last year of more than 2 million children that found no significant associations between acetaminophen use during pregnancy and children’s risk of autism, ADHD or intellectual disability.
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 say that the paper could only show an association, the research could not show that acetaminophen caused autism.
“We recommend judicious acetaminophen use — lowest effective dose, shortest duration — under medical guidance, tailored to individual risk–benefit assessments, rather than a broad limitation,” the researchers wrote in that analysis.
After the Trump news conference, medicine regulatory agencies for the European Union and the United Kingdom and Health Canada quickly issued statements confirming that taking the over-the-counter pain-reliever during pregnancy remains safe.
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