By Pt Jyothi Datta

Copyright thehindubusinessline

Even as the United States administration red-flagged the use of acetaminophen in pregnant women raising concerns over possible links to autism – global regulators and experts weighed in on paracetamol and its safety, when used judiciously.

Soumya Swaminathan, former Chief Scientist with the World Health Organization, told businessline, “Common sense and good medical practice will always say minimise the use of drugs. Don’t unnecessarily take medication, don’t self-medicate, and particularly during pregnancy – you need to be sure you’re taking medicine for the right reason and at the right dose and for the right duration.” Pointing to the risk-benefit assessment for any drug, she said a doctor would prescribe it because “benefits outweigh the risks.”

Reassuring young or expectant mothers, Swaminathan said, “Paracetamol is still the safest option.” Cautioning that people could switch to other, more toxic drugs, she said, one could take the drug for fever or pain, with “the general principle of avoiding medication.” Taking a paracetamol or two for a fever is not going to cause any harm, she said, advising people to talk to their doctor if there was prolonged treatment, as not taking a medicine could cause more damage.

Regulatory authorities from the United Kingdom and Europe, for example, echoed Swaminathan’s words.

They were reacting to the US Food and Drug Administration’s (USFDA) announcement raising concerns around acetaminophen use in pregnant women and possible links to neurological conditions like autism. The announcement was amplified by US President Donald Trump, and the Health Secretary Robert Kennedy Jr – causing a global stir, and putting the spotlight on drugs like Tylenol and other paracetamols.

Global regulators

Alison Cave, Chief Safety Officer at the UK MHRA (Medicines and Healthcare products Regulatory Agency) said, “There is no evidence that taking paracetamol during pregnancy causes autism in children. Paracetamol remains the recommended pain relief option for pregnant women when used as directed.”

The European Medicines Agency (EMA) advisory read, “In the European Union, paracetamol (also known as acetaminophen) can be used for reducing pain or fever during pregnancy if clinically needed. There is currently no new evidence that would require changes to the current EU recommendations for use.”

In fact, the USFDA Commissioner’s letter to doctors called on them to minimise using acetaminophen during pregnancy for routine low-grade fevers. “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,” he added.

International brand Tylenol is from Kenvue (formerly J&J’s consumer health business), and the company told foreign media, it disagreed the drug posed a health risk to expecting mothers. The brand is not available in India. No public advisory was put out in India on the issue.

Published on September 23, 2025