Safety of switching from brand-name to generic levetiracetam in patients with epilepsy

2017
journal article
article
13
cris.lastimport.wos2024-04-09T22:38:36Z
dc.abstract.enPurpose: The approach to the use of generic antiepileptic drugs has recently evolved from major concern to general acceptance, but the evidence related specifically to the safety of switching from brand-name to generic levetiracetam (LEV) is scarce. The aim of the study was to assess the risk of increased frequency of seizures or other adverse events after replacement of a brand-name LEV with a generic one. Patients and methods: This retrospective analysis included 159 patients treated with LEV in a tertiary outpatient epilepsy clinic. We included all patients diagnosed with epilepsy who were treated with LEV as at March 1, 2013. Most patients were forced to switch to the generic LEV because of the sudden rise in cost of the branded LEV. We recorded data on age, sex, age at onset of epilepsy, type of epilepsy, and its treatment. We analyzed data from one visit before potential switching and from two visits after the potential switching. The interval between visits was typically 3 months. We registered an increase in the frequency of seizures and in the occurrence of adverse events. Results: Among 151 subjects who switched to generic LEV after March 1, 2013, increased frequency of seizures was noted in 9 patients (6%) during the first follow-up visit. Patients with increased frequency of seizures did not differ from other patients regarding sex, age, age at the onset of epilepsy, and the median dose of LEV before switching or the median duration of treatment with LEV before switching. Two patients returned to brand-name LEV. Adverse events were noted in six other patients (4%) and included somnolence, irritability, or dizziness. Conclusion: Switching from brand-name to generic LEV is generally safe.pl
dc.affiliationWydział Lekarski : Klinika Neurologiipl
dc.affiliationWydział Lekarski : Zakład Neurogenetykipl
dc.cm.date2020-01-07
dc.cm.id84832
dc.contributor.authorBosak, Magdalena - 214374 pl
dc.contributor.authorSłowik, Agnieszka - 133430 pl
dc.contributor.authorTuraj, Wojciech - 133696 pl
dc.date.accessioned2020-01-17T09:17:49Z
dc.date.available2020-01-17T09:17:49Z
dc.date.issued2017pl
dc.date.openaccess0
dc.description.accesstimew momencie opublikowania
dc.description.physical2287-2291pl
dc.description.points35pl
dc.description.versionostateczna wersja wydawcy
dc.description.volume11pl
dc.identifier.doi10.2147/DDDT.S138270pl
dc.identifier.eissn1177-8881
dc.identifier.projectROD UJ / OPpl
dc.identifier.urihttps://ruj.uj.edu.pl/xmlui/handle/item/141270
dc.languageengpl
dc.language.containerengpl
dc.rightsUdzielam licencji. Uznanie autorstwa - Użycie niekomercyjne 3.0*
dc.rights.licenceCC-BY-NC
dc.rights.urihttp://creativecommons.org/licenses/by-nc/3.0/legalcode*
dc.share.typeotwarte czasopismo
dc.subject.enlevetiracetampl
dc.subject.engenericpl
dc.subject.enbrandedpl
dc.subject.enepilepsypl
dc.subject.enswitchingpl
dc.subject.enadverse eventpl
dc.subtypeArticlepl
dc.titleSafety of switching from brand-name to generic levetiracetam in patients with epilepsypl
dc.title.journalDrug Design, Development and Therapypl
dc.typeJournalArticlepl
dspace.entity.typePublication
cris.lastimport.wos
2024-04-09T22:38:36Z
dc.abstract.enpl
Purpose: The approach to the use of generic antiepileptic drugs has recently evolved from major concern to general acceptance, but the evidence related specifically to the safety of switching from brand-name to generic levetiracetam (LEV) is scarce. The aim of the study was to assess the risk of increased frequency of seizures or other adverse events after replacement of a brand-name LEV with a generic one. Patients and methods: This retrospective analysis included 159 patients treated with LEV in a tertiary outpatient epilepsy clinic. We included all patients diagnosed with epilepsy who were treated with LEV as at March 1, 2013. Most patients were forced to switch to the generic LEV because of the sudden rise in cost of the branded LEV. We recorded data on age, sex, age at onset of epilepsy, type of epilepsy, and its treatment. We analyzed data from one visit before potential switching and from two visits after the potential switching. The interval between visits was typically 3 months. We registered an increase in the frequency of seizures and in the occurrence of adverse events. Results: Among 151 subjects who switched to generic LEV after March 1, 2013, increased frequency of seizures was noted in 9 patients (6%) during the first follow-up visit. Patients with increased frequency of seizures did not differ from other patients regarding sex, age, age at the onset of epilepsy, and the median dose of LEV before switching or the median duration of treatment with LEV before switching. Two patients returned to brand-name LEV. Adverse events were noted in six other patients (4%) and included somnolence, irritability, or dizziness. Conclusion: Switching from brand-name to generic LEV is generally safe.
dc.affiliationpl
Wydział Lekarski : Klinika Neurologii
dc.affiliationpl
Wydział Lekarski : Zakład Neurogenetyki
dc.cm.date
2020-01-07
dc.cm.id
84832
dc.contributor.authorpl
Bosak, Magdalena - 214374
dc.contributor.authorpl
Słowik, Agnieszka - 133430
dc.contributor.authorpl
Turaj, Wojciech - 133696
dc.date.accessioned
2020-01-17T09:17:49Z
dc.date.available
2020-01-17T09:17:49Z
dc.date.issuedpl
2017
dc.date.openaccess
0
dc.description.accesstime
w momencie opublikowania
dc.description.physicalpl
2287-2291
dc.description.pointspl
35
dc.description.version
ostateczna wersja wydawcy
dc.description.volumepl
11
dc.identifier.doipl
10.2147/DDDT.S138270
dc.identifier.eissn
1177-8881
dc.identifier.projectpl
ROD UJ / OP
dc.identifier.uri
https://ruj.uj.edu.pl/xmlui/handle/item/141270
dc.languagepl
eng
dc.language.containerpl
eng
dc.rights*
Udzielam licencji. Uznanie autorstwa - Użycie niekomercyjne 3.0
dc.rights.licence
CC-BY-NC
dc.rights.uri*
http://creativecommons.org/licenses/by-nc/3.0/legalcode
dc.share.type
otwarte czasopismo
dc.subject.enpl
levetiracetam
dc.subject.enpl
generic
dc.subject.enpl
branded
dc.subject.enpl
epilepsy
dc.subject.enpl
switching
dc.subject.enpl
adverse event
dc.subtypepl
Article
dc.titlepl
Safety of switching from brand-name to generic levetiracetam in patients with epilepsy
dc.title.journalpl
Drug Design, Development and Therapy
dc.typepl
JournalArticle
dspace.entity.type
Publication
Affiliations

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