Tylenol Maker Challenges Proposed Label Change on Pain Reliever’s Pregnancy Use Linked to Autism Risk
Kenvue, the manufacturer of Tylenol, has expressed opposition to proposed changes to the product’s safety label as suggested by the US Food and Drug Administration (FDA). This proposal stems from emerging research that suggests a possible link between the use of acetaminophen during pregnancy and the development of autism or ADHD in children.
Kenvue’s Stance on FDA Label Changes
Kenvue asserts that acetaminophen is among the most thoroughly studied medications available. The company contends that altering the label would be “arbitrary, capricious, and contrary to law.” Tylenol generates approximately $1 billion in annual revenue, making it Kenvue’s leading product according to brokerage firm Morningstar.
Current Label and Responses to Concerns
The existing Tylenol label advises pregnant or breastfeeding individuals to consult a healthcare professional before use. The discussion around changing this label gained momentum after a recent press conference where former President Donald Trump urged pregnant women to avoid Tylenol, suggesting without evidence that it was linked to a heightened risk of autism.
- Tylenol is considered the safest over-the-counter pain reliever for pregnant individuals.
- Many studies indicate that most people use acetaminophen at some point during their pregnancy.
- Alternatives like ibuprofen can raise the risk of serious complications during pregnancy.
Government Responses and Scientific Backing
After the press conference, US Health and Human Services Secretary Robert F. Kennedy Jr. announced a public service campaign regarding the safety of acetaminophen. The FDA indicated that while the decision to use Tylenol is ultimately with parents, there may be an increased risk of neurological conditions like autism and ADHD in children. However, they emphasized that a definitive causal relationship has not been established, with research yielding contradictory findings.
The Informed Consent Action Network, which opposes vaccination, has filed a citizen’s petition with the FDA seeking clearer warnings on acetaminophen labels regarding its potential risks during pregnancy.
Kenvue’s Opposition to the Petition
Kenvue has urged the FDA to dismiss this petition, arguing that any proposed label changes lack solid scientific support and deviate from the FDA’s historical position on acetaminophen use in pregnancy. The company met with Secretary Kennedy earlier this year, reinforcing their stance that there is no proven link between acetaminophen use and autism.
No Changes on the FDA Website
The FDA’s website on acetaminophen has not been updated to reflect the administration’s recent claims. As of August, it stated that no conclusive evidence connects appropriate acetaminophen use during pregnancy to adverse outcomes.
Scientific Findings on Acetaminophen
According to the American College of Obstetricians & Gynecologists, extensive studies have shown no reputable evidence establishing a connection between acetaminophen use during any trimester of pregnancy and neurodevelopmental disorders in children. Notably, a recent large-scale study involving over 2 million children found no significant link between prenatal acetaminophen use and autism or ADHD.
A subsequent analysis of 46 studies highlighted an apparent association between acetaminophen use and autism but stressed that correlation does not prove causation. The researchers recommended cautious use of acetaminophen guided by medical advice, focusing on the lowest effective dose for the shortest duration.
International Reassurances
Following the controversies ignited by the press conference, medical authorities in the European Union, the United Kingdom, and Health Canada quickly reaffirmed the safety of acetaminophen for pregnant individuals.
