In paracetamol preparations, the possible but extremely rare occurrence of metabolic acidosis (High anion gap metabolic acidosis, HAGMA) has long been mentioned in the instructions for use. In the future, however, all manufacturers of paracetamol medicines must state more clearly in the package instructions the risk of HAGMA. Also that the frequency of this side effect is “not known”.

The relevant decision was taken at the end of October by the Pharmacovigilance and Risk Assessment Committee (PRAC), which is subject to the European Medicines Agency (EMA) and was notified by the German Federal Institute for Medicines and Medicinal Products.

Increased anion gap metabolic acidosis (HAGMA) is a rare but potentially life-threatening acidosis of the body. It is crucial for the body that the blood has a constant pH value between 7.36 and 7.44. The pH value is a measure of the acidity of a solution. If the metabolism is disturbed, but also the fixed ratio between acids and bases, the blood may become too acidic. The so-called anion gap occurs when the pH of the blood falls below 7.35.

Paracetamol is a safe drug

In acidosis, breathing becomes difficult and sufferers breathe more than normal. Doctors talk about hyperventilation when someone breathes too fast and deeply. Typical symptoms include confusion, weakness and loss of consciousness.

An overdose of paracetamol may lead to hyperacidity of the blood in people with disturbed metabolism. However, this happens very rarely. People with severe kidney dysfunction and sepsis are at increased risk. If metabolic acidosis (HAGMA) is diagnosed in time, paracetamol treatment should be stopped immediately. In case of extremely severe acidosis, the pH value of the blood is restored with specific buffering substances.

Paracetamol is an effective and safe medicine for pain relief and fever reduction. Although paracetamol puts less of a burden on the stomach than ibuprofen or Acetylsalicylic acid (Aspirin), paracetamol may, in rare cases, cause abdominal pain, nausea or even vomiting. Another known, but also very rare, side effect of paracetamol is allergic reactions, such as itching, skin rashes or swelling.

Be careful with the dosage!

Patients often underestimate the risks associated with over-the-counter medications. The fact that paracetamol and other painkillers are sold in several countries at supermarket checkouts, next to chewing gum, does not mean that uncontrolled consumption is harmless. Overdose, especially in combination with alcohol consumption or an existing liver disease, may cause significant damage to the liver

As is known, the liver breaks down paracetamol into its components, which are then eliminated by the body. If the active substance is taken in too high a dose or for too long, the liver becomes overloaded. The liver cannot break down the toxic intermediate metabolite N-acetyl-p-benzoquinonimine (NAPQI), which can damage liver cells and, in severe cases, lead to acute liver failure.

Editor: Stefanos Georgakopoulos