Generika in der Epilepsietherapie

The approval of gen- eric preparations for the first two of the so-called new antiepileptic drugs (AEDs; gabapentin and la- motrigine) is reason for the Ger- man Society for Epileptology (Deutsche Gesellschaft fur Epilep- tologie; DGfE) to comment from a medical point of view on the usage of generics as AEDs once more in addition to an earlier paper re- garding the "aut idem" problem. Generic preparations can in gen- eral be used without problems for the initial treatment or for alter- native therapy with AEDs if a switch is considered anyhow due to insufficient efficacy or toler- ability. However, patients with freedom from seizures and side effects should not be switched unfoundedly from a branded to a generic preparation, between dif- ferent generics or from an generic to a branded preparation. There- fore, the DGfE recommends cor- respondent statements on the pre- scription (crossing of the "aut idem" field or inscription/stamp "no substitution") as well as in- forming the patients or their rela- tives. The potential risks related to switches between different AED preparations with the same active ingredient have to be reasonably low in view of the physician and the patient. If a switch is consid- ered, the patients have to be in- formed about the risks of seizure recurrence or reduced tolerability and asked for their consent. Otherwise the physician is liable to damage claims in case of occur- ring problems.