Disclaimer: This article is for informational purposes only and is not intended to serve as medical advice. Always consult your healthcare provider before taking any medication, including Tylenol (acetaminophen), during pregnancy or while breastfeeding.
The FDA is updating Tylenol’s label to warn of a possible association with autism. The news spawned panic among many mothers and frustration within the medical community. If you’ve been pregnant, you know that Tylenol is the only recommended painkiller and fever reducer for those 40 grueling weeks.
Now the federal government says it might be unsafe. What does that mean for moms?
I spoke with Dr. Shaun Grannis from Regenstrief Institute and the IU School of Medicine. As a medical doctor and informatics expert, he works closely with medical research. I asked him to explain the available evidence on Tylenol and pregnancy.
Dr. Grannis summarized the body of research this way: “The evidence supports using Tylenol. The strongest studies have not shown a correlation between the medication and autism, and leaving maternal fevers untreated poses significant risks to the baby.”
Let’s dig a little deeper into the data and the government’s declaration.
How do the FDA and other governing bodies decide when to issue warnings?
Federal regulators, like the FDA, and professional societies like the American College of Obstetrics and Gynecology (ACOG) review available studies to evaluate the risks and benefits of medications, then update labels or advisories when the balance of science shifts. For example, when research reveals new or strengthened information about side effects.
These boards and committees can interpret the same science differently, sometimes resulting in divergent recommendations. That’s what is happening with Tylenol. The FDA warns of potential danger, while ACOG — made up of doctors who treat pregnant women — says the medicine is safe and beneficial.
What does the FDA announcement mean?
The FDA stated there is a possible association between Tylenol use during pregnancy and neurodevelopmental outcomes like ADHD and autism. It’s not saying the drug causes the issues.
The federal agency is drawing its conclusion from observational studies.
Dr. Grannis said, “Observational studies are not the most rigorous research method. They can show correlation, not causation.”
He used the example of ice cream and drownings. In the summer, drownings and ice cream consumption increase. Does that mean ice cream causes drowning? No. The real factor is likely heat, which prompts more people to swim, and more swimmers means more drownings.
When it comes to research on Tylenol, Dr. Grannis said robust studies that control for other variables do not show an association with autism.
What causes autism?
There is no conclusive evidence about what causes autism, but the existing research suggests it’s likely a variety of factors.
“High-quality studies find autism is 70 to 90% hereditary, indicating a powerful genetic component. Environmental factors matter, too, like maternal fever and infection during pregnancy, or a lack of prenatal nutrients,” said Dr. Grannis. “It’s not any one thing that causes the condition.”
He had a strong message for mothers. “If you took Tylenol during pregnancy, and your child has autism, you did not fail your child. You made the best decision with the best guidance available.
“Focus on the here and now. The most important thing is getting support tailored to your child’s needs. These interventions are where you can change the child’s trajectory. ”
Again, Tylenol is recommended as the safest medication to reduce fever during pregnancy. Dr Grannis said that, as with any drug, you should take the lowest effective dose for the shortest amount of time.
Talk to your doctor before taking Tylenol or any other medication.
