Due to too many overdoses and intoxications, the Medicines Agency has decided to reduce the dosage of colchicine-based treatments, indicated to prevent or treat gout.
Because of too manycolchicine poisoningan oral medication indicated for prevent or treat heart disease dropL’Medicines Agency (ANSM) decided to reduce the dosage of this treatmentshe announced in a press release dated October 10, 2023. To reduce the risk of overdose, an alert message mentioning the new dosage has been affixed to boxes of Colchicine Opocalcium® and Colchimax® from Mayoly Spindler Laboratories, used in the curative or preventive treatment of gout (since July 1, 2023). The old dosage schedule should no longer be followed. Here is the new dosage schedule to follow:
In case of acute attack of gout:
► Day 1:
- Initiate colchicine as quickly as possible
- Loading dose 1 mg
- Followed one hour later by 0.5 mg
► From day 2: 0.5 mg 2 to 3 times a day depending on the evolution of the pathology and the possible occurrence of signs of intolerance
In the case of prophylaxis of acute attacks of gout in chronic gouty patients, particularly when initiating urate-lowering treatment
► Patients without renal and/or hepatic insufficiency: 0.5 mg to 1 mg per day depending on the evolution of the pathology and the possible occurrence of signs of intolerance
► Patients with mild to moderate renal and/or hepatic impairment: Start at 0.5 mg per day
► In the event of an adverse effect and moderate renal insufficiency: Reduce dosage to 0.5 mg every other day
The decision to reduce the dosage was taken in accordance with the recommendations of the learned societies, European Alliance of Associations for Rheumatology (EULAR) and Société Française de Rheumatologie (SFR). This information is mainly intended healthcare professionals who can prescribe colchicine such as general practitioners, rheumatologists, geriatricians, cardiologists, nephrologists, hepatologists, internists, community pharmacists, hospital pharmacists, nurses and healthcare executives.
Reduce or stop treatment if diarrhea, nausea or vomiting occurs
The ANSM insists on the fact thatin case of diarrhea, nausea or vomitingsigns of potential colchicine overdose, treatment with colchicine should be reduced or stopped. Gout disease corresponds to un excess uric acid in the blood (called hyperuricemia). Uric acid comes from the breakdown of purines present in many foods (red meats, offal, alcohol, beer, sugary drinks, etc.). This pathology which would affect more than 600,000 French people (4 times more men affected than women) according to a study presented at the French Congress of Rheumatology, manifests itself by the occurrence of joint inflammatory outbreaks called “gout attacks“.