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

Drug Design, Development and Therapy Aug 11, 2017

Bosak M, et al. – Here the physicians evaluated the risk of increased frequency of seizures or other adverse events after replacement of a brand–name levetiracetam (LEV) with a generic one. They approved that switching from brand–name to generic LEV was generally safe.

Methods

  •  This study enrolled 159 patients treated with LEV in a tertiary outpatient epilepsy clinic. 
  • This study consisted of all patients diagnosed with epilepsy who were treated with LEV as at March 1, 2013. 
  • Because of the sudden rise in cost of the branded LEV, most patients were forced to switch to the generic LEV.
  • Data on age, sex, age at onset of epilepsy, type of epilepsy, and its treatment were reviewed. 
  • Data from one visit before potential switching and from two visits after the potential switching were also evaluated. 
  • The interval between visits was typically 3 months.
  • An increase in the frequency of seizures and in the occurrence of adverse events was reported.

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.
  • In six other patients (4%), adverse events were noted and included somnolence, irritability, or dizziness.

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