Kenvue said that the warning language could result in pregnant women getting discouraged from seeking treatment for pain and fever.
Kenvue Brands LLC, the manufacturer of Tylenol, sent a letter to the Food and Drug Administration on Oct. 17, pushing back against demands to modify the medication’s label to show more safety warnings.
On Sept. 22, federal officials said that Tylenol use during pregnancy is likely associated with autism and that pregnant women should not take the drug unless they have severe fevers. The FDA sent a letter to doctors on Sept. 22, notifying them that using the drug during pregnancy “may be associated with an increased risk of neurological conditions.”
The same day, nonprofit group Informed Consent Action Network submitted a citizen petition to FDA Commissioner Martin Makary regarding safety-related labeling changes for drug products containing acetaminophen during pregnancy. Tylenol is one of the brand names for acetaminophen.
The petition asked for labels on these drugs to be revised to reflect potential risks that frequent prenatal use of acetaminophen has on the neurodevelopment of fetuses, “including an increased risk of autism spectrum disorder (‘ASD’) and attention deficit/hyperactivity disorder (‘ADHD’).”
In its Oct. 17 letter to the FDA, Kenvue stated that the label change requests were “unsupported by the scientific evidence and legally and procedurally improper.”
The company has continuously evaluated the science on the use of acetaminophen during pregnancy and on neurodevelopmental disorders for over a decade, the letter said. Yet, Kenvue has “found no causal association,” it said.
“The expansive scientific evidence developed over many years does not support a causal link, as confirmed in the Food and Drug Administration’s (‘FDA’) own public statements and analyses,” the company said.
According to an Aug. 14 update on acetaminophen published by the FDA, the agency has “not found clear evidence” that the appropriate use of the drug during pregnancy would result in harms such as negative neurobehavioral or developmental outcomes among children.
However, the FDA recommended that pregnant women consult with a health care professional before using any drugs, including acetaminophen.
Kenvue said that adding warning language to labels could result in pregnant women getting discouraged from seeking medically appropriate treatment for pain and fever.
According to the Tylenol website, the drug’s label already contains a warning: “If pregnant or breast-feeding, talk to your healthcare professional before use.”
