As announced in December 2024, Sanofi Belgium has decided to stop marketing Depakine 300 mg/5 ml syrup as of 28 April 2025. Depakine's other oral liquid formulation, the 300 mg/ml oral solution, will remain available in Belgium. As the latter is more concentrated than the syrup and dosed with a different device, patients, healthcare professionals and parents need to be informed and prepared to avoid potential medication errors.
Context
In Belgium, Depakine (sodium valproate) is indicated as monotherapy or polytherapy for the treatment of numerous epileptic disorders (summary of product characteristics). Two oral liquid forms of Depakine are currently marketed:
- Depakine 300 mg/5 ml syrup: contains 300 mg valproate per 5 ml (i.e. 60 mg per 1 ml), supplied with a graduated dosing beaker for dosing between 150 mg and 600 mg;
- Depakine 300 mg/ml oral solution: contains 300 mg sodium valproate per 1 ml, supplied with a graduated dosing pipette for dosing from 50 mg to 400 mg.
From 28 April 2025
Sanofi Belgium has previously informed healthcare professionals that Depakine 300 mg/5 ml syrup will be definitively withdrawn from the Belgian market, and that no further batches of this formulation will be marketed after 28 April 2025.
The oral liquid formulation Depakine 300 mg/ml oral solution, will still be available on the market for patients for whom an oral liquid form of Depakine is required or preferred.
However, Depakine 300 mg/ml oral solution is five times more concentrated than Depakine 300 mg/5 ml syrup and must be administered using a graduated dosing pipette. Whereas, the syrup was dosed with a graduated dosing beaker.
To avoid any risk of medication error in patients who will transition to Depakine 300 mg/ml oral solution as soon as the syrup is no longer marketed, we strongly encourage prescribers, pharmacists and patients/healthcare professionnals/parents to carefully reread the recommendations detailed in our Flash VIG-news of 13 December 2024 and in the Folia published by the Belgian Centre for Pharmacotherapeutic Information (BCFI/CBIP).