title: [Generics of antiepileptic drugs].
abstract: Generic substitution of antiepileptic drugs (EAD) have limited use because epilepsy is a chronic disease, seizure recurrence has an important impact of the quality of life and the potential risk of accidents. EADs have a narrow therapeutic window, non negligible side effects and complex interactions. Bioavailability of generic EADs, tested in healthy men during a limited period of time must be within the 90% IC, in which means that serum levels can range from 80% to 125% of the original drug. A slight drop in serum level could increase the risk of seizure recurrence, as indicated by several publications. Although no formal studies regarding cost effectiveness and the rate of seizure recurrence is available yet, the prevailing consensus recommends not to replace an original antiepileptic drug by a generic, due to the harmful risk of seizure recurrence.
authors.affiliation: Unité d'épileptologie, Service de neurologie, Departement des neurosciences cliniques, CHUV, 01011 Lausanne. malin.maeder-ingvar@chuv.ch
authors.forename: M
authors.initials: M
authors.lastname: Maeder-Ingvar
authors.forename: G B
authors.initials: GB
authors.lastname: Foletti
mesh_terms: D000927:Anticonvulsants / Q000191:economics / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016527:Drug Costs; D004347:Drug Interactions; D011307:Drug Prescriptions; D016568:Drugs, Generic / Q000009:adverse effects* / Q000191:economics / Q000493:pharmacokinetics / Q000627:therapeutic use*; D004827:Epilepsy / Q000188:drug therapy*; D006801:Humans; D017410:Practice Guidelines as Topic; D011788:Quality of Life; D012307:Risk Factors; D055502:Secondary Prevention; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000927:Anticonvulsants; D016568:Drugs, Generic