Vimpat® (Epilepsy)

In August 2008, the European Commission approved Vimpat® (lacosamide) tablets (50, 100, 150 and 200 mg), syrup (15 mg/ml) and solution for infusion (10 mg/ml) as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization in patients with epilepsy, aged 16 years and older. Vimpat® solution for infusion is an alternative for patients when oral administration is temporarily not feasible.

July 22nd 2011 – Update on Vimpat® 15 mg/ml syrup in Europe

UCB, in agreement with the European Medicines Agency (EMA), will implement a voluntary recall of Vimpat® (lacosamide) 15 mg/ml syrup at the pharmacy level in Europe on 15th September 2011.

The recall is due to a quality defect with the Vimpat® 15 mg/ml syrup. To date, no cases of adverse effects or lack of effect due to the quality defect of Vimpat® 15 mg/ml syrup have been reported and the recall is therefore a precautionary measure.

This matter is only associated with the Vimpat® 15 mg/ml syrup formulation. Other formulations of Vimpat® available in Europe (film-coated tablet and solution for infusion) are not impacted. The Vimpat® 10 mg/ml oral solution that is available in the US is also not impacted.

It is important that patients do not suddenly stop taking Vimpat® 15 mg/ml syrup or make changes to their treatment without first speaking to their doctor. Patients currently taking Vimpat® 15 mg/ml syrup are advised to consult with their treating physician as soon as possible.

For further information please go here.

In the US, Vimpat® is indicated for partial-onset seizures: tablets and oral solution are indicated for adjunctive therapy in patients age 17 and over. Injection is indicated as short term replacement when oral administration is not feasible in these patients

SmPC Vimpat® (EU). Sourced from www.ema.europa.eu.