Tylenol Maker Challenges Proposed Label Change on Pregnancy Autism Link
Kenvue, the manufacturer of Tylenol, opposes potential modifications to the product’s safety label. The proposed changes stem from research suggesting a link between acetaminophen use during pregnancy and increased rates of autism and ADHD in children.
Concerns Over Label Changes
Kenvue argues that acetaminophen, the active ingredient in Tylenol, has undergone extensive research, making it one of the most studied medications in history. The company asserts that making the proposed label changes would be arbitrary and contrary to established law.
Financial Impact
- Tylenol generates approximately $1 billion annually for Kenvue.
- It is the company’s top-selling product, according to brokerage firm Morningstar.
Recent Developments
The discussion for altering the label arose following a news conference by former President Donald Trump. He advised pregnant women to avoid Tylenol, suggesting it could heighten the risk of autism, without providing scientific evidence for his claims. Trump stated that expecting mothers should “fight like hell not to take it.”
Evidence indicates that most women utilize acetaminophen at some point during their pregnancies. Other pain relief options such as ibuprofen or aspirin can pose serious risks during pregnancy. Unmanaged pain or fever poses dangers for both mothers and fetuses, potentially leading to miscarriage or birth complications.
FDA and Public Health Initiatives
The Food and Drug Administration (FDA) has informed physicians that decisions about Tylenol usage during pregnancy should remain with the parents. However, they also indicated that there might be an increased risk of neurological issues, including autism and ADHD. Despite this, they clarified that a direct causal relationship has not been established.
Response from Health Organizations
The American College of Obstetricians & Gynecologists has stated that decades of research do not provide evidence supporting the idea that acetaminophen causes neurodevelopmental disorders. A recent study involving over two million children found no significant correlation between acetaminophen use during pregnancy and autism or ADHD.
Calls for Action and Recommendations
The Informed Consent Action Network, an organization focused on vaccine transparency, filed a citizen’s petition with the FDA. They argue that urgent public health measures are needed, advocating for stronger warnings on acetaminophen labels regarding potential neurodevelopmental risks during pregnancy.
- Kenvue requests the FDA to dismiss this petition, citing a lack of scientific backing for the proposed label changes.
- The FDA’s website on acetaminophen remains unchanged, affirming the safety of its use during pregnancy based on existing research.
Following Trump’s comments, health authorities in the European Union, the United Kingdom, and Health Canada reiterated that acetaminophen remains a safe option for pain relief during pregnancy.
