The Food and Drug Administration (FDA) announced that it has initiated the process of changing the labeling for Tylenol in light of President Trump’s announcement that acetaminophen is linked to autism development when used during pregnancy.
“The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen,” said FDA Commissioner Marty Makary. “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.”
A letter was also sent to physicians nationwide to inform them of the accumulation of 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.”
“Some studies have described that the risk may be most pronounced when acetaminophen is taken chronically throughout pregnancy to childbirth,” Makary wrote. “These concerns may be magnified by the fact that a very young child’s liver may still be developing and thus a child’s ability to metabolize the drug may be limited.”
The letter noted that while there are “contrary studies in the scientific literature,” clinicians should still “consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers.”
He explained that the consideration “should also be balanced with the fact that acetaminophen is the safest over-the-counter alternative in pregnancy among all analgesics and antipyretics; aspirin and ibuprofen have well-documented adverse impacts on the fetus.”
President Trump announced Monday that data links prenatal use of acetaminophen, commonly sold as Tylenol, to an increased risk of autism.
Amid criticism for the announcement, social media users were quick to point out that Tylenol did not recommend using its product during pregnancy, writing in 2017, “We actually don’t recommend using any of our products while pregnant. Thank you for taking the time to voice your concerns today.”
