The mention is written in red capital letters and is surmounted by a warning triangle: "Overdose = danger. Exceeding the dose can destroy the liver. "This is a major message. We wanted it direct and visible. That is why, in order to be seen by everyone, it will be affixed on the front of the boxes. In the back, we opted for a pedagogical reminder of good practices, "explains Dr. Dominique Martin.
The product mentioned by the boss of the ANSM, policeman of the drug in France, is paracetamol. Star pharmacies, the Doliprane, Efferalgan, Fervex and other Dafalgan are the most sold drugs in France, with consumption up 53% in ten years. The figure is colossal: one billion boxes pass each year, 84% delivered after a medical prescription. "But mainly for use in self-medication," says Dominique Martin.
This is why this new pictogram, which Le Parisien-Aujourd'hui unveils in France, will appear on the 200 paracetamol specialties alone or in combination with other substances. "It is very important to inform, because the risk is not known. It is not known that excessive paracetamol can have dramatic consequences on the liver, especially in the malnourished, who consume alcohol or who abuse it to calm, for example, a toothache, "decrypts the Cyrille Ferray, gastroenterologist and hepatologist at the Paul Brousse hospital in Villejuif (Val-de-Marne).
First cause of drug-induced liver transplantation
"With normal consumption, it is a safe and effective medicine. But in overdose, it is the first cause of liver transplantation of drug origin, "adds the director of the ANSM.
Although there is no precise data on the incidents related to the molecule, Dominique Martin notes that she has "enough information to make it a public health issue". According to the French Observatory of Analgesic Drugs (OFMA) which reveals its figures, 52% of the population had, in 2018, "at least" a reimbursed prescription of paracetamol. Among them, 11.3% had at least six deliveries during the year.
"This gives an idea of the proportion of patients with potentially chronic use of paracetamol," decrypts its president, Professor Nicolas Authier. Note: the consumer is 56% … a consumer with an average age of 42 years.
Nine months to comply
On July 12, 2018, paracetamol made a lot of noise. That day, the Strasbourg prosecutor indicated that the death of Naomi Musenga, a young woman mocked on the phone by Samu, was due to paracetamol poisoning. Since then, his parents have rebelled against this interpretation, which goes beyond the conclusions of the autopsy.
But the alert, she remained. A month later, the ANSM launched a public consultation to raise public awareness. 2,300 people participated, including 75% of individuals. "The health democracy worked," notes Dominique Martin. 97% of respondents opted to add a clear message on the boxes.
Now, laboratories have nine months to comply. "We will look at whether this measure has a concrete impact", promises Dominique Martin. Otherwise, it does not exclude additional measures, including a strengthening of the prescribing conditions.
In 2017, Nancy's Faculty of Medicine conducted a study on the uses of paracetamol. 19.1% of the patients surveyed gave answers placing them in a potential situation of involuntary overdose.