EMA Clarifies Paracetamol Warnings On Risk Of Blood And Fluid Abnormality

EMA's PRAC clarifies risk of high anion gap metabolic acidosis (HAGMA) in users of OTC paracetamol with new package leaflet and SmPC warnings.

Paracetamol
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OTC and Rx single ingredient and fixed dose combination drugs containing paracetamol marketed in the EU are set to carry an updated warning about the risk of a serious blood and fluid abnormality.

Following a review of all the available evidence of a link between paracetamol use and high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis, the European Medicines Agency’s Pharmacovigilance...

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