Health authorities in Greece and Europe are sending a clear message, despite the public debate surrounding acetaminophen that took on political dimensions in the US following Donald Trump’s statements. In an announcement issued on Tuesday (23/9), the Greek National Organization for Medicines (EOF) emphasizes that guidelines for acetaminophen (or paracetamol) use by pregnant women have not been modified in Greece or the European Union. The EOF references the position of the European Medicines Agency (EMA), according to which the drug can be used to treat pain or fever during pregnancy only when medically necessary.
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The EMA emphasizes that there is no new scientific data justifying changes to existing guidelines and, as with any short-term treatment, use should be limited to the lowest effective dose, for the shortest possible duration, and with the lowest possible frequency.
Available data spanning decades shows no risk of malformations for the fetus or newborn. In 2019, the EMA examined studies on neurodevelopment of children exposed to acetaminophen during pregnancy and concluded there is no conclusive evidence or documented connection to neurodevelopmental disorders.
EMA: “Acetaminophen remains an important option for treating pain or fever in pregnant women“
“Acetaminophen remains an important option for treating pain or fever in pregnant women,” emphasized Steffen Thirstrup, EMA’s chief medical officer. “Our recommendations are based on rigorous evaluation of available scientific data. We have found no evidence that acetaminophen use during pregnancy causes autism in children.”
Health authorities remind that pregnant women should always consult their doctor before taking any medication. The EMA, EOF, and other competent national authorities emphasize they will continue monitoring acetaminophen safety, immediately evaluate new data when it emerges, and take all necessary measures to protect public health.