The European Medicines Agency (EMA) has recommended that lacosamide (Vimpat®) 15mg/ml syrup is discontinued. This product is licensed for the treatment of partial-onset seizures as an adjunctive therapy in patients with epilepsy aged 16 years and older.
This product was recalled voluntarily in September 2011 due to a quality issue that resulted in an uneven distribution or precipitation of the active ingredient. Changes to the storage recommendations of the product have not remedied this defect.
Patients are advised to continue taking their medication but to consult with their doctor. A license application for a 10mg/ml liquid product has been submitted. This product is not affected by this quality issue and is already available in the United States.
Clinicians should consider using lacosamide film coated tablets where appropriate. It may be possible to obtain the lower strength liquid product on a named patient basis where tablets will not be an option.
Action: Clinicians should be aware of this recommendation. The number of affected individuals should be small but changes to treatment will need careful planning.