The European Medicines Agency (EMA) has confirmed that recommendations on the use of paracetamol (acetaminophen) during pregnancy remain unchanged, stressing that the medicine should continue to be used when clinically needed.
Current guidance advises that the medicine should be used only when necessary, at the lowest effective dose and for the shortest duration possible. This approach is consistent with recommendations for all medicines used for acute treatments.
According to the EMA, extensive historical data shows no evidence that paracetamol poses a risk to the developing foetus or newborn. Additionally, in 2019, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) conducted a review of studies into the neurodevelopment of children exposed to paracetamol in utero. The review concluded that results were inconclusive and no causal link with neurodevelopmental disorders could be established.
Steffen Thirstrup, EMA’s Chief Medical Officer, said: “Paracetamol remains an important option to treat pain or fever in pregnant women. Our advice is based on a rigorous assessment of the available scientific data and we have found no evidence that taking paracetamol during pregnancy causes autism in children.”
The clarification comes after US President Donald Trump suggested earlier this week that pregnant women should stop taking paracetamol – known in the US as Tylenol – due to an alleged increased risk of autism.
Other healthcare bodies have also rejected the claim. Steven J Fleischman, president of the American College of Obstetricians and Gynecologists (ACOG), stated: “Suggestions that acetaminophen use in pregnancy causes autism are not only highly concerning to clinicians, but also irresponsible when considering the harmful and confusing message they send to pregnant patients.”