By Pt Jyothi Datta

Copyright thehindubusinessline

The United States Food and Drug Administration (USFDA) has sent a letter to doctors on the use of acetaminophen in pregnant women, raising concerns over possible links to autism. The announcement has caused a stir, putting the spotlight on the use of drugs like Tylenol, another paracetamols.

“In recent years, evidence has accumulated 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. 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 metabolise the drug may be limited,” USFDA Commissioner Marty Makary said in a letter to physicians.

The announcement was amplified by US President Donald Trump, and the Health Secretary Robert Kennedy Jr, speaking from the White House, on Monday. The US health agency has also initiated the process for a label change for acetaminophen (Tylenol and similar products), it said, “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.”

Minimise use

The FDA Commissioner’s letter further added, “while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature. The association is an ongoing area of scientific debate and clinicians should be aware of the issue in their clinical decision-making, especially given that most short-term fevers in pregnant women and young children do not require medication.”

While he called on the medical community, to “consider minimising the use of acetaminophen during pregnancy for routine low-grade fevers,” the letter added, “This 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.”

The international brand Tylenol is from Kenvue (formerly J&J’s consumer health business), and the company told BBC, “We believe independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers.” Tylenol is not sold in India, but businessline has reached out to Kenvue on the US developments.

Working with GSK

Parallelly, the USFDA said, it had initiated the approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD), a neurological condition affecting folate (a vitamin essential for brain health) transport into the brain. Individuals with CFD have been observed with “developmental delays with autistic features (eg, challenges with social communication, sensory processing and repetitive behaviours), seizures and problems with movement and coordination,” the FDA said. Further, FDA officials said, the agency was collaborating with GSK (GlaxoSmithKline) “to broaden the existing Wellcovorin label.”

GSK confirmed in a statement, that USFDA “requested GSK take this action as part of the agency’s initiative to investigate opportunities to repurpose older medications for the treatment of chronic diseases.” The company said, it “will submit a supplemental New Drug Application (sNDA) for Wellcovorin (leucovorin) to update the label to include an indication for the treatment of cerebral folate deficiency (CFD), a rare disorder” GSK does not manufacture or market leucovorin, which is available in generic formulations in the US, it added.

Published on September 23, 2025