French and European health authorities have commented on a possible link between paracetamol use during pregnancy and autism, as suggested by US President Donald J. Trump.

At a recent White House press conference, he strongly advised against the use of paracetamol by pregnant women, associating it with a high risk for autism in children and prompting responses from European and global health authorities.

Trump stated, “not take it” and “not give it to your baby,” and announced plans to review US Food and Drug Administration (FDA) labelling of the drug.

He referenced the Amish community in the US and Cuba, noting low rates of autism in populations where paracetamol and vaccinations are less frequently used, implying a potential link.

Scientists worldwide have responded to these comments, which the scientific community considers to be unfounded.

In France, the French National Agency for the Safety of Medicines (ANSM) and the Reference Centre for Teratogenic Agents (CRAT) issued statements refuting these claims.

At the international level, the European Medicines Agency (EMA) and the World Health Organization (WHO) have similarly addressed these remarks, emphasising that current evidence does not support a link between prenatal paracetamol exposure and autism.

French and EU Responses

In France, the ANSM published a press release stating that “to date, available data does not show a link between taking paracetamol during pregnancy and autism,” adding that the extensive data on pregnant women do not show a risk for foetal or neonatal toxicity in the developing foetus or in newborns.

Echoing the US FDA’s recent decision to update paracetamol labelling, the ANSM stated that “there is currently no new data justifying a change in the recommendations for the use of paracetamol during pregnancy.”

For Public Sénat, Benoit Marin, PhD, and head of CRAT, took stock of what science really said that “the data he relies on are contradictory, incomplete, and insufficiently substantiated.”

“Recently, various studies have been conducted internationally, for example, in Japan, with publication last September. Some studies have found a potential link; however, they are heterogeneous and have several methodological weaknesses. Medical practices cannot be changed on such a basis.”

The EMA has reaffirmed that there is no evidence linking prenatal paracetamol (acetaminophen) exposure to autism, stating, “There is currently no new evidence that would require changes to the current EU recommendations for use.”

Marine further dismissed references to Cuba and the Amish because they were not supported by rigorous scientific results.

Marin emphasised that experts, including those at the CRAT and the French authority on medication use during pregnancy, agree that there is no evidence of a proven risk for neurodevelopmental disorders in children from prenatal paracetamol exposure. He added that the more rigorous and bias-controlled the studies, the less likely they were to confirm any association.

The EMA confirmed that extensive data from pregnant women exposed to paracetamol showed no increased risk for malformations in the foetus or newborn. The agency noted that this information was already included in EU product labelling and that no changes were needed, unlike the updates being considered by the FDA.

WHO stated in a press release that “there is ample and strong evidence that childhood vaccines do not cause autism,” noting that “large-scale, high-quality studies conducted in many countries have all reached the same conclusion.”

European health authorities, aiming to be reassuring yet cautious, stated, “When needed, paracetamol can be used during pregnancy. As with any medicine for acute treatment, it should be used at the lowest effective dose, for the shortest possible time, and as infrequently as possible.”

This story was translated from Medscape’s French edition.