USFDA warns doctors on acetaminophen use in pregnancy amid autism, ADHD concerns

“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 on Tuesday.

The move follows controversial remarks by President Donald Trump and Health Secretary Robert Kennedy Jr, who claimed that Tylenol and similar products may raise the risk of autism.

Their comments coincided with the announcement of new regulatory guidance to physicians.

India’s paracetamol exports in spotlight

Tylenol is manufactured by Kenvue, formerly the consumer health unit of Johnson & Johnson. Acetaminophen and paracetamol are chemically identical, differing only in name usage — acetaminophen in the US and Japan, and paracetamol in most other countries.

It remains unclear whether the FDA’s advisory could impact India’s paracetamol shipments to the US. According to Directorate General of Foreign Trade (DGFT) data, India exported paracetamol worth $182.31 billion in 2023–24, with $21.98 billion going to the US.

FDA: association not conclusive

In its letter, the US regulator said that while several studies have suggested a link between acetaminophen use in pregnancy and autism, “a causal relationship has not been established and there are contrary findings in the scientific literature.”

The FDA advised clinicians to minimise use during pregnancy for treating routine low-grade fevers, but also stressed that acetaminophen remains the safest over-the-counter (OTC) option for pregnant women compared with aspirin and ibuprofen, both of which have known harmful effects on foetal health.