SEATTLE — The Food and Drug Administration (FDA) has initiated the process to begin changing the label on acetaminophen, commonly known as Tylenol.
This comes after President Donald Trump said taking Tylenol is “not good” for pregnant women.
President Trump claims it “can be associated with a very increased risk of autism.”
“The body of evidence supporting the use of acetaminophen is longstanding and its been looked at by multiple groups and over time,” Professor of Obstetrics and Gynecology at the University of Washington, Dr. Linda Eckert said.
In its statement, the FDA said “It is important to note that while an association between acetaminophen and neurological conditions has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature.”
The FDA calls out two studies, and notes that “some studies have described that the risk may be most pronounced when acetaminophen is taken chronically throughout pregnancy.”
Eckert said it is a fraught area to research because it is difficult to control for all the necessary factors. She said if a study is not done well, you can find associations Eckert added, “An association with autism does not mean that Tylenol caused the autism.”
Eckert has been caring for pregnant people for 30 years.
“I think this is just going to make it even harder for them to make those decisions and to get accurate information,” she said.
Best practice already makes it so Tylenol is taken “judiciously,” and called that “commonsense in pregnancy” and taking it for fevers, for example, could not be more important, according to Eckert.
“Besides the obvious, just discomfort, high fevers in pregnancy can actually lead to fetal malformations in and of themselves; they can lead to early contractions, they can raise the fetal heart rate,” she said. “So a high fever in pregnancy itself can cause problems in utero.”
Untreated pain can also cause problems, like high blood pressure, according to Eckert.
The FDA and Trump also point out that there is no other over-the-counter drug that is safe to take during pregnancy for pain relief or fevers, Eckert mentioned.
In addition to physical health effects, Eckert also worries about the mental health toll this might take on pregnant patients.
“If an individual happens to have a baby born with autism or ADHD, will statements like this make that person carry even more guilt or more harm to themselves that they already might feel,” Eckert said. “Even though the data and science support the use [this messaging] can be harmful.”
In a statement, FDA Commissioner Dr. Marty Makary said, “The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen. Even with this body of evidence, the choice still belongs with parents. The precautionary principle may lead many to avoid using acetaminophen during pregnancy, especially since most low-grade fevers don’t require treatment. It remains reasonable, however, for pregnant women to use acetaminophen in certain scenarios.”
The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen. Even with this body of evidence, the choice still belongs with parents.
Labels will be changed “to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children,” the FDA said.
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