Hoechst Marion Roussel has revised the Summaries of Product Characteristics for both Sabril (vigabatrin) sachets and tablets, following a review conducted in conjunction with the European Commitee for Proprietory Medicinal Products (CPMP). Sabril is now indicated for use in combination with other anti-epileptic drugs for patients with resistant partial epilepsy with or without secondary generalisation, where all other appropriate drug combinations have proved inadequate or have not been tolerated.
The maximum recommended dose in adults and children weighing over 50kg has been reduced to 3g daily. The recommended starting dose for infants is 50mg/kg/day. A boxed warning and additional information on monitoring procedures to detect visual field defects has been added to the special warnings and precautions section. The SPC should be referred to for other changes.