Even familiar medications can pose unexpected risks. There is now a new warning for paracetamol.
Paracetamol is one of the most commonly used painkillers in Germany. Most people have it in their medicine cabinet. But now there are new findings that urge caution. The European Medicines Agency (Ema) and its Pharmacovigilance Risk Assessment Committee (PRAC) have decided to change the product information for medicines containing paracetamol. The reason for this is a serious risk that was hardly known until now.
Paracetamol in therapeutic doses can trigger a so-called metabolic acidosis with an enlarged anion gap when administered over a long period of time or in the event of an overdose. This is a dangerous metabolic disorder.
People with certain risk factors such as severe kidney dysfunction, sepsis or glutathione deficiency are particularly at risk – the latter can be caused by chronic alcohol abuse or malnutrition.
According to Ema, the specialist information for all medicines that contain paracetamol will now be adjusted to provide information about this risk. The frequency of the side effect is stated as “not known”. This applies to both paracetamol as a single medication and combination preparations that also contain other active ingredients.
Patients taking acetaminophen and experiencing symptoms of metabolic acidosis should seek immediate medical attention. If the suspicion is confirmed, the medication is stopped immediately and the patient is monitored closely. If you have any questions about the medication, those affected should seek advice from their doctor's office or pharmacy.
