Tylenol maker: possible FDA label change ‘unsupported by scientific evidence’

[Thiệu Ngô]

Tylenol maker pushes back on FDA, denies autism link in pregnancy warning

By Nathaniel Weixel

Tylenol maker Kenvue is calling on the Food and Drug Administration (FDA) to back off a proposed safety label change to acetaminophen after the Trump administration linked its use during pregnancy to autism.

In response to a citizen petition filed last month, the company said the “expansive scientific evidence developed over many years” does not support a causal link between acetaminophen use in pregnancy and developmental disorders.

“Acetaminophen is one of the most studied medicines in history, and scientific evidence regarding acetaminophen use in pregnancy and neurodevelopmental outcomes has been continuously evaluated by FDA and industry for more than a decade,” Kenvue said.

Acetaminophen is the only pain reliever considered safe for pregnant women. The company noted that adopting the change would be “arbitrary, capricious, and contrary to law.”

“The labeling request is unsupported by scientific evidence and would represent an unexplained departure from FDA’s longstanding position on acetaminophen during pregnancy,” Kenvue said.

The citizen petition was filed by the Informed Consent Action Network, an anti-vaccine nonprofit with close ties to Health Secretary Robert F. Kennedy Jr.

The petition was filed Sept. 22, the same day President Trump and Kennedy warned pregnant women against taking Tylenol due to an unproven link to autism during a White House news conference.

“Don’t take it. Fight like hell not to take it,” Trump repeatedly said, urging pregnant women to “tough it out” if they are in pain.

The current label instructs people who are pregnant or breastfeeding to “ask a health professional before use.”

Kenvue said it met with Kennedy and other HHS staff in early September after he reached out to “express his view about an association between acetaminophen and autism.”

The company said it told Kennedy the science did not support a causal link for pregnant women, nor did it support an association between postnatal use of acetaminophen and autism and attention-deficit hyperactivity disorder.

While the FDA said it was going to add a warning about the potential link, federal officials have sounded a softer tone.

In a letter to doctors, FDA Commissioner Marty Makary said “a causal relationship has not been established and there are contrary studies in the scientific literature”.