USFDA cautions doctors on acetaminophen use in pregnancy, cites risks

The US drug regulator flagged concerns over acetaminophen use in pregnancy, citing studies linking it to autism and ADHD, while noting no proven causal relationship

The United States Food and Drug Administration (USFDA) on Tuesday said it had sent a letter to doctors on the use of acetaminophen (Tylenol) and other paracetamol products in pregnant women, raising concerns over possible links to autism and attention deficit hyperactivity disorder (ADHD).

 

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

 

This comes after US President Donald Trump and US Health Secretary Robert Kennedy Jr made controversial claims linking the common painkiller Tylenol and similar products to an increased risk of autism, while announcing new regulatory guidance alerting physicians.

   

Tylenol is manufactured by Kenvue, formerly the consumer health arm of US-based Johnson & Johnson (J&J).

 

Acetaminophen and paracetamol are the same active medicine, with differences only in name usage. Acetaminophen is used mainly in the US and Japan, while paracetamol is the common name in most of the world.

 

There is currently no clarity on whether the announcements could affect India’s paracetamol exports to the US.

 

According to data from the Directorate General of Foreign Trade (DGFT), India exported paracetamol worth $182.31 billion in 2023–24. Of this, exports to the US amounted to $21.98 billion.

 

In its letter to physicians, the US drug regulator said that while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established and there are contrary findings 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,” the agency said.

 

The FDA added that clinicians should consider minimising the use of acetaminophen during pregnancy for routine low-grade fevers in the spirit of patient safety and prudent medicine.

 

“This consideration should also be balanced with the fact that acetaminophen is the safest over-the-counter (OTC) alternative in pregnancy among all analgesics and antipyretics. Aspirin and ibuprofen have well-documented adverse impacts on the foetus,” it stated.