Intrapatient variation in antiepileptic drug plasma concentration after generic substitution vs stable brand-name drug regimens

Generic substitution of antiepileptic drugs (AEDs) in the treatment of epilepsy is still controversial due to the lack of consensus and clear guidance for clinicians (Privitera, 2013; Shaw and Hartman, 2010). Retrospective studies and anecdotal reports suggested a potential relationship between brand-name vs generic AED switching and adverse effects, especially loss of seizure control, raising concerns among clinicians and patients about the use of generic formulations. A few prospective randomized studies did not confirm the safety risks shown in observational studies, but they must be considered cautiously due to methodological flaws, including small patient samples, short follow-ups and recall bias from subjective reports (Kesselheim et al., 2010; Steinhoff et al., 2009; Talati et al., 2012; Yamada and Welty, 2011).

Source: Epilepsy Research - March 2, 2016 Category: Neurology Authors: Manuela Contin, Lucia Alberghini, Carmina Candela, Giulia Benini, Roberto Riva Source Type: research