The ANSM announced on Tuesday that a statement would soon be added to all boxes of medicines containing paracetamol to remind them of the risks associated with an overdose, in particular for the liver.
Laboratories have a few months to add the words “overdose = danger” on their boxes of drugs containing paracetamol, announced this Tuesday the Medicines Agency (ANSM). “This measure follows the public consultation launched by the ANSM in August 2018 to raise awareness among patients and healthcare professionals of the risk of liver toxicity in the event of an overdose. It concerns more than 200 paracetamol-based specialties marketed in France”.
“Paracetamol can cause serious liver damage”
Paracetamol is the most commonly prescribed and used medicine for fever and pain, in both adults and children. It is present in many drugs, alone or in combination with other active substances. Used wisely, it is “safe and effective”, but in the event of an overdose, “paracetamol can lead to serious irreversible liver damage in some cases”. If the ANSM took this measure, it is because “the misuse of paracetamol is the 1time cause of drug-induced liver transplantation in France”.
Two different boxes depending on the type of assay
Thus, for paracetamol-only medicines, the red box below will appear on the front of the box and “will also be accompanied by information aimed at reducing the risk of overdose and therefore liver damage” on the back of the box (such as the maximum dose per intake and per day, respecting the time between two intakes, the exclusion of taking another medicine containing paracetamol, etc.).
For medicines based on paracetamol combined with another active substance, another box will appear on the front of the box:
Recommendations for use
The ANSM recalls the recommendations for good use, in particular that “the lowest dose, for the shortest possible time” is to be preferred:
– Respect the maximum daily dose and the recommended duration of treatment
– Check the presence of paracetamol in other medicines (Used for pain, fever, allergies, cold symptoms or flu-like illness)
– Alert special populations (-50kg, mild to moderate liver failure, severe kidney failure, chronic alcoholism, etc.)
