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The French National Agency for the Safety of Medicines and Health Products (ANSM) has asked pharmaceutical companies in France to add a warning message to boxes of medicines containing paracetamol. This measure aims to raise awareness among patients of the risks of liver toxicity in the event of an overdose. This article examines the reasons and implications of this decision.
Role of the ANSM and importance of drug monitoring
The ANSM’s mission is to evaluate drugs and health products available on the French market. If necessary, it makes the necessary decisions to ensure and strengthen the health safety of the French. A team of scientists works there constantly to monitor the side effects of drugs, particularly those that can be dangerous.
The Problem of Paracetamol Overdose
Paracetamol is an active ingredient found in many common medications such as Doliprane and Efferalgan. These medications, available over the counter, are widely used to relieve pain and reduce fever in adults and children. However, an overdose of paracetamol can lead to serious side effects, including liver toxicity.
In France, manufacturers of these painkillers sell nearly 14 boxes per second, or about 422 million boxes per year. This considerable figure has attracted the attention of health authorities, prompting the ANSM to take measures to prevent accidental overdoses.
Studies and research on the toxicity of paracetamol
According to a press release from the ANSM dated July 9, 2019, paracetamol is safe and effective when used as recommended. However, in case of overdose, it can cause severe side effects affecting the liver, cardiovascular system, gastrointestinal tract, hematological system and skin. Overdose can occur in several ways, including exceeding the prescribed dose, prolonging the duration of treatment, taking a large amount of tablets at one time, or combining several medications containing paracetamol.
A recent systematic review of observational studies highlighted the significant toxicity associated with the use of paracetamol, particularly at the upper limit of standard doses. Dominique Martin, Director General of ANSM, emphasizes that although serious side effects are rare, they can be extremely serious.
New mandatory information on medication boxes
To reduce the risk of overdose, the ANSM has requested that products containing only paracetamol carry warnings in red, such as “Overdose = Danger” and “Taking more than the recommended dose can damage your liver”. Laboratories must also indicate the maximum admissible dose per dose, the maximum quantity not to be exceeded in 24 hours, the minimum time between two doses and a warning against the simultaneous use of other products containing paracetamol.
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