The Ordem dos Farmacêuticos (OF) stated in an internal memo that the studies cited to support claims linking paracetamol use during pregnancy to neurodevelopmental changes in children are of small scale and have methodological limitations that are acknowledged by the authors themselves.
The OF emphasized that a review of published scientific research, conducted by the Medicinal Product Information Center of the Order of Pharmacists, does not support this alleged relationship.
In the internal note, the OF highlighted the largest study on this subject, which analyzed approximately 2.5 million children and gathered data from nearly 186,000 who were exposed to paracetamol during pregnancy, noting it “found no evidence of increased risk when genetic and environmental factors were considered alongside prenatal exposure, through the comparison with siblings not exposed to the analgesic.”
It was noted that the association between neurodevelopmental changes, particularly attention deficit hyperactivity disorder (ADHD) and autism spectrum disorders (ASD), and the use of paracetamol during pregnancy has been investigated for many years, but the studies cited by those making such claims “do not adequately account for other influencing factors, like genetic and environmental considerations and the mother’s clinical condition.”
The OF acknowledged that several studies have pointed to a higher incidence of ADHD and ASD in children of mothers who used paracetamol during pregnancy but emphasized that these studies also recognized limitations preventing a causal relationship from being established.
“An analysis of current evidence (scientific information) suggests it is unlikely that paracetamol exposure during pregnancy is associated with a clinically significant risk of developing ADHD or ASD during childhood,” the document stated.
The OF noted that studies suggesting such associations “are heterogeneous and present significant methodological limitations, while those with appropriate structure do not substantiate it.”
Based on the existing data, the OF stated that there is no scientific basis for altering clinical guidelines for the treatment of pain and fever during pregnancy.
“Paracetamol remains an essential treatment option for pregnant women, observing the principle of using the lowest effective dose for the shortest duration,” it noted.
It also reiterated the institution’s and pharmacists’ commitment to a practice grounded in scientific research and the defense of public health.
The OF reminded that pharmacists, due to their close relationship with the public, are essential in clarifying doubts, combating misinformation, and promoting health literacy, contributing to informed choices and the safe and rational use of medicines.
On Monday, U.S. President Donald Trump suggested that the increase in autism in the country might be linked to the use of the analgesic paracetamol by pregnant women and vaccinations, without providing scientific evidence.
Today, Infarmed clarified that there is no connection between the use of paracetamol by pregnant women and malformations in the fetus or newborns and informed that the use of this analgesic during pregnancy remains unchanged, emphasizing the lack of evidence to warrant changes in recommendations regarding its use in the European Union.
It was added that, in 2019, the European Medicines Agency (EMA) reviewed available studies investigating the neurodevelopment of children exposed to paracetamol in utero, concluding that “the results were inconclusive” and “it was not possible to establish a link with neurodevelopmental disorders.”
