Appropriate use of generic and branded antiseizure medications in epilepsy: Updated recommendations from the Italian League Against Epilepsy (LICE).

Abstract

Generic drugs are increasingly used to treat many diseases including epilepsy. The growing importance of generic antiseizure medications (ASMs) has led the ASMs commission of the Italian League Against Epilepsy (LICE) to review current evidence in the literature about efficacy and safety of these products. Recommendations from other scientific organizations have also been considered to provide an update of the LICE position about their utilization (List of Recommendations). Compared with the previous literature review, randomized controlled trials assessing bioequivalence among branded drugs and generics are currently available. Although some contrasting results have been reported, brand-to-generic switching was effective and tolerable in real-life settings, with similar adverse event ratios. Based on these findings, LICE concluded that, conforming to the rigorous regulation of USA and EU markets, generic ASMs are not inferior to the respective branded, providing a cost advantage for patients starting or replacing monotherapy or add-on, and for those with incomplete seizure control. Branded-to-generic (and vice versa) switching is not recommended (although applicable) during seizure remission, as well as the generic-to-other generic switching. Other recommendations focus on the appropriateness of therapeutic drug monitoring (TDM) when switching is required, paying attention to avoiding the erroneous switch between modified and immediate-release formulations during dispensation. Finally, to support patients' compliance, they should be assured of generics' safety and efficacy and carefully informed with practical advice, particularly when the switching is associated with aspect modifications (e.g. color and shape changes) of the pill or the packaging.

• Authors: Roberta Roberti, Alessandro Casarella, Alfonso Iudice, Angela La Neve, Ettore Beghi, Giuseppe Capovilla, Carlo Di Bonaventura, Filippo S Giorgi, Salvatore Grosso, Luigi F Iannone, Andrea Romigi, Luigi M Specchio, Gaetano Zaccara, Oriano Mecarelli, Emilio Russo, Antiseizure Medications Commission of the Italian League against Epilepsy LICE
• Journal: Epilepsy & behavior : E&B (Epilepsy Behav) Vol. 116 Pg. 107804 (03 2021) ISSN: 1525-5069 [Electronic] United States
• PMID: 33581599 (Publication Type: Journal Article, Review)
• Copyright: Copyright © 2021 Elsevier Inc. All rights reserved.

Chemical References

• Anticonvulsants
• Drugs, Generic

Topics

• Animals
• Anticonvulsants (therapeutic use)
• Drugs, Generic (therapeutic use)
• Epilepsy (drug therapy)
• Humans
• Italy
• Phthiraptera