Tylenol Manufacturer Resists Proposed Label Changes

Authored by Naveen Athrappully via The Epoch Times (emphasis ours),

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.”

Tylenol and Autism

In the Sept. 22 letter sent to doctors, the FDA said that “an association between acetaminophen and autism has been described in many studies.” However, “a causal relationship has not been established and there are contrary studies in the scientific literature,” it said.

During a news briefing that day, Makary said that “we now have data we cannot ignore.”

A 2019 paper published in “JAMA Psychiatry” found evidence that babies exposed to the drug while in the womb had a significantly higher risk of developing ADHD or autism.

However, a 2024 analysis of almost 2.5 million children from Sweden found no link between autism and fetal exposure to acetaminophen.

Back in March 2017, Tylenol said in a post on X, “We actually don’t recommend using any of our products while pregnant.”

Kenvue’s Oct. 17 letter to the FDA criticized comments made by the Trump administration during a Sept. 22 press conference.

“Taking Tylenol is not good,” Trump said while referring to the FDA’s Sept. 22 notice to doctors.

“For this reason, they are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary. That’s, for instance, in cases of extremely high fever, that you feel you can’t tough it out, you can’t do it. So ideally, you don’t take it at all.”

Kenvue said that the comments made during the press conference, attended by Health and Human Services Secretary Robert F. Kennedy Jr. and other officials, “diverged from FDA’s long-established approach to acetaminophen use during pregnancy.”

The announcement “included repeated incorrect statements about the well-established safety profile of acetaminophen, in general, and Tylenol, in particular, including statements implying a causal association between acetaminophen use during pregnancy and ASD,” the letter stated.

On Sept. 22, the FDA announced it had initiated the process for making label changes to acetaminophen drugs such as Tylenol.

“The FDA is taking action to make parents and doctors aware of a considerable body of evidence about potential risks associated with acetaminophen,” Makary said.

“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.”

One in 31 American children is estimated to have autism, according to an April 15 report from the Centers for Disease Control and Prevention.

Studies and Recommendations

An Aug. 14 study published in the journal “Environmental Health” looked at 46 studies that examined links between prenatal acetaminophen exposure and neurodevelopmental disorders or related symptoms among offspring.

Out of the 46 studies, 27 reported positive associations with “significant links” to neurodevelopmental disorders, it said, adding that higher-quality studies were likely to show such associations.

“Appropriate and immediate steps should be taken to advise pregnant women to limit acetaminophen consumption to protect their offspring’s neurodevelopment,” the study said, adding that more than 50 percent of pregnant women globally are estimated to use acetaminophen.

However, a September advisory issued by the American College of Obstetricians and Gynecologists said that acetaminophen remains the “analgesic and antipyretic of choice during pregnancy.”

The group said current evidence “does not support a causal link” between prenatal acetaminophen use and neurodevelopmental disorders.

“Clinicians should continue to recommend its judicious use, provide evidence-based counseling, and reassure patients that current data do not support a causal link to neurodevelopmental disorders,” the group recommended.