Vimpat 15 mg/mL syrup for the treatment of partial-onset seizures will be recalled because of a quality defect in some batches, leading to an uneven distribution of the active substance lacosamide. The recall will begin on Sept 15, 2011, to allow sufficient time for patients to be switched to suitable alternatives (see advice below). The precipitate consists of the active substance lacosamide and is not a contamination. This quality defect affects only the syrup.
Advice for healthcare professionals:
doctors should contact their patients to switch them to Vimpat film-coated tablets if possible
a10 mg/mL oral solution currently authorised in the USA and undergoing authorisation in the EU may be made available on a named-patients basis for those who cannot take the tablets
do not start any new patients on Vimpat 15 mg/mL syrup