Kenvue, the American company behind Tylenol, says the US Food and Drug Administration should not make proposed changes to the product’s safety label reflecting research about a possible link between its use during pregnancy and autism or ADHD diagnoses in children.The company emphasizes that acetaminophen, the generic name for Tylenol, also called paracetamol is “one of the most studied medicines in history” and argues that adopting the proposed label warning would be arbitrary, capricious, and unlawful.Tylenol generates roughly $1 billion annually for Kenvue and remains the company’s top-selling brand, according to Morningstar. The current label advises pregnant or breastfeeding individuals to “ask a health professional before use.”Kenvue: Push for Label Change Sparks AttentionThe call for a label change gained attention after former President Donald Trump held a news conference last month, telling pregnant women in pain to try to “tough it out” instead of taking Tylenol, even though acetaminophen is widely considered the safest over-the-counter pain reliever during pregnancy.Trump claimed, without evidence, that taking Tylenol during pregnancy is linked to a “very increased risk of autism.” “Fight like hell not to take it,” he urged.Most pregnant people use acetaminophen at some point, studies show. Other common pain or fever treatments, such as ibuprofen or regular-dose aspirin, can increase the risk of serious complications during pregnancy. Untreated pain or fever can also be dangerous, possibly leading to miscarriage, birth defects, or high blood pressure.Kenvue And Tylenol: FDA and Public Health ActionsBeginning the process to change acetaminophen labels was one of several steps the Trump administration planned. HHS Secretary Robert F. Kennedy Jr. said his agency would also launch a public service campaign about the issue.The FDA sent a letter to physicians noting that the decision to take Tylenol “still belongs with parents,” while also warning that its use during pregnancy may carry an “increased risk of neurological conditions such as autism and ADHD in children.”However, the letter stressed that “a causal relationship has not been established” and that studies examining a potential link are “contradictory,” as per CNN.Citizen Petition FiledThe Informed Consent Action Network, an anti-vaccine nonprofit closely tied to Kennedy, filed a citizen petition with the FDA on the same day as Trump’s news conference. Citizen petitions allow individuals, industry groups, or consumer organizations to request FDA action on specific issues.The petition claimed that, because of “urgent public health implications,” the FDA should add a warning to acetaminophen labels stating 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.”Kenvue RespondsOn Friday, Kenvue formally asked the FDA to deny the petition, saying that the proposed label changes are unsupported by scientific evidence and would represent a departure from the FDA’s longstanding position on acetaminophen during pregnancy. The company said it had met with Kennedy in early September after he suggested a link between acetaminophen use during pregnancy and autism, and Kenvue informed him there was no such connection.FDA Guidance and Global ResponseThe FDA website on acetaminophen has not been updated to reflect the Trump administration’s views. The last update, in August, states, “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, and according to the American College of Obstetricians & Gynecologists, no reputable study has concluded that its use in any trimester causes neurodevelopmental disorders in children.Following Trump’s news conference, medicine regulatory agencies in the European Union, United Kingdom, and Canada quickly released statements confirming that acetaminophen remains safe for pregnant individuals.
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