Medicines watchdog in Spain issues advice about paracetamol after Donald Trump linked it to autism

The Spanish medicines agency Aemps has reported that there is no evidence that causally links the use of paracetamol during pregnancy with autism in children. It pointed out that pregnant women can continue taking this medicine when necessary, "always following the recommendation to use the lowest possible dose that reduces pain or fever and to use it for the shortest possible time".

On 22 September 2025, the US food and drug administration (FDA) issued a press release announcing that it will add the possible link between the use of paracetamol during pregnancy and subsequent diagnoses of autism or attention deficit hyperactivity disorder (ADHD) in offspring in the medicine's leaflet. However, the FDA's statement stressed that a causal relationship has not been established and reminds that treatment of fever during pregnancy may be necessary in certain cases.

What the Aemps recommends when it comes to administering paracetamol for pregnant women suffering from pain or fever is to manage each case with caution and attention to each woman's individual circumstances. The agency stated that "untreated fever and intense pain also carry risks".

Aemps has reminded the public that, in 2019, the pharmacovigilance risk assessment committee (PRAC) of the European Medicines Agency (EMA) reviewed a safety warning regarding the possible impact of paracetamol use during pregnancy on neurodevelopment in children. The PRAC pointed out that the evidence available in the scientific literature on neurodevelopmental disorders, including non-clinical and epidemiological studies, was inconclusive.

As a consequence, the information on medicines containing paracetamol was updated to reflect the outcome of this review, including the following warning: "Epidemiological studies on neurodevelopment in children exposed to paracetamol in the uterus show inconclusive results."

In addition, according to the information currently authorised in the EU, a large amount of data from pregnant women who used paracetamol during pregnancy indicates that there is no risk of malformations in the developing foetus or in newborns.

On this point, Aemps indicated that, as with all medicinal products, the EMA and the EU national competent authorities (including Aemps) continuously monitor the safety of paracetamol-containing medicinal products. Should new information be identified that would modify the risk-benefit balance or the conditions of use, the Aemps will communicate this through its usual channels.

Therefore, the agency insists that paracetamol can be used during pregnancy according to the leaflet instructions. The lowest possible dose that reduces pain or fever should be taken at all times, for the shortest possible period of time.

If in doubt about how to treat fever or pain during pregnancy, if these symptoms do not decrease or if you need to take the medicine more frequently, you should always consult a healthcare professional.