Infarmed denies link between paracetamol and autism

Infarmed clarified this Tuesday that there is no link between the use of paracetamol by pregnant women and malformations in the fetus or newborns, after the US President suggested a link between this painkiller and the increase in autism.

On Thursday, Donald Trump suggested, without presenting scientific evidence , that the rise in autism in the country may be caused by the use of the painkiller paracetamol in pregnant women and vaccination.

Flanked by Robert F. Kennedy Jr., Secretary of Health and one of the faces of the anti-vaccine movement in the country, Trump suggested imposing limits on the use of acetaminophen—better known in the United States by the brand name Tylenol—during pregnancy, citing the drug as a possible cause of autism, although this causal link has been investigated and not proven.

This Tuesday, the National Medicines Authority (Infarmed) reported that the use of paracetamol during pregnancy remains unchanged , insisting on the lack of evidence to justify changes in the recommendations regarding the use of that analgesic in the European Union.

It says that, in 2019, the European Medicines Agency (EMA) reviewed the available studies that investigated the neurodevelopment of children exposed to paracetamol “in utero”, concluding that “the results were inconclusive” and that “it was not possible to establish a link with neurodevelopmental disorders”.

“A large amount of data from pregnant women who used this medicine during pregnancy indicates that there is no risk of malformations in the developing fetus or in newborns,” he says.

Infarmed emphasizes that, when necessary, paracetamol can be used during pregnancy and explains: “As with any acute treatment medication, it should be used at the lowest effective dose, for the shortest possible period and as little frequently as necessary.”

Pregnant women are also advised to speak to their healthcare professional if they have questions regarding any medication during pregnancy.

The EMA and the competent national authorities in the EU “will continue to monitor the safety of medicines containing paracetamol and rapidly evaluate any new data that emerge,” the note said, adding that regulatory measures will be taken “whenever justified” in order to protect public health.

On Monday, Trump said acetaminophen is "possibly associated with a much higher risk of autism," advising women not to take it during pregnancy , but he did not present any scientific evidence.

Alternatively, he presented rumors that “there is practically no autism” in Cuba because the country cannot afford to buy Tylenol, the most popular brand of paracetamol.

Experts have stated that the increase in cases in the United States is largely due to a new definition of the disorder, which now includes mild cases on a "spectrum" and more precise diagnoses, and that there is no single cause.