PMID- 21426334
OWN - NLM
STAT- MEDLINE
DCOM- 20110601
LR  - 20211020
IS  - 1528-1167 (Electronic)
IS  - 0013-9580 (Print)
IS  - 0013-9580 (Linking)
VI  - 52
IP  - 4
DP  - 2011 Apr
TI  - Clinical experience with generic levetiracetam in people with epilepsy.
PG  - 810-5
LID - 10.1111/j.1528-1167.2011.03025.x [doi]
AB  - PURPOSE: To describe the clinical outcomes of a compulsory switch from branded to 
      generic levetiracetam (LEV) among people with epilepsy (PWE) in an outpatient 
      setting. METHODS: We conducted a retrospective chart review of 760 unduplicated 
      consecutive adult patients attending a tertiary care epilepsy clinic at Ben Taub 
      General Hospital. On November 1, 2008 hospital policy required all patients 
      receiving branded LEV to be automatically switched to generic LEV. We calculated 
      the proportion of patients switching back to branded LEV and reasons for the 
      switch back. KEY FINDINGS: Of the 260 patients (34%) being prescribed LEV 
      (generic and brand name) during the study period, 105 (42.9%) were switched back 
      to brand name LEV by their treating physicians. Reasons for switch back included 
      increase in seizure frequency (19.6% vs. 1.6%; p < 0.0001) and adverse effects 
      (AEs) (3.3%). AEs included headache, fatigue, and aggression. Patient age was 
      associated with switchback when controlling for gender, epilepsy classification, 
      and treatment characteristics [relative risk (RR) 2.44; 95% confidence interval 
      (CI) 2.09-2.84; p < 0.05)]. An increase in seizure frequency subsequent to 
      generic substitution was associated with polytherapy compared to monotherapy 
      (3.225; 1.512-6.880; p < 0.05). SIGNIFICANCE: A significant proportion of 
      patients in our cohort on generic LEV required switch back to the branded drug. 
      Careful monitoring is imperative because a compulsory switch from branded to 
      generic LEV may lead to poor clinical outcomes, with risk of AEs and increased 
      seizure frequency.
CI  - Wiley Periodicals, Inc. (c) 2011 International League Against Epilepsy.
FAU - Chaluvadi, Siresha
AU  - Chaluvadi S
AD  - Department of Neurology, Baylor College of Medicine, Houston, Texas, USA. 
      chaluvad@bcm.edu
FAU - Chiang, Sharon
AU  - Chiang S
FAU - Tran, Larry
AU  - Tran L
FAU - Goldsmith, Corey E
AU  - Goldsmith CE
FAU - Friedman, David E
AU  - Friedman DE
LA  - eng
GR  - T32 CA096520/CA/NCI NIH HHS/United States
PT  - Journal Article
DEP - 20110322
PL  - United States
TA  - Epilepsia
JT  - Epilepsia
JID - 2983306R
RN  - 0 (Anticonvulsants)
RN  - 0 (Drugs, Generic)
RN  - 44YRR34555 (Levetiracetam)
RN  - ZH516LNZ10 (Piracetam)
SB  - IM
MH  - Adult
MH  - Anticonvulsants/*pharmacokinetics
MH  - Cohort Studies
MH  - Drug Substitution/adverse effects
MH  - Drugs, Generic/*pharmacokinetics
MH  - Epilepsy/*drug therapy/prevention & control
MH  - Female
MH  - Hospitalization/trends
MH  - Humans
MH  - Levetiracetam
MH  - Male
MH  - Middle Aged
MH  - Piracetam/*analogs & derivatives/pharmacokinetics
MH  - Retrospective Studies
MH  - Seizures/drug therapy/prevention & control
MH  - Treatment Failure
PMC - PMC4500114
MID - NIHMS705857
EDAT- 2011/03/24 06:00
MHDA- 2011/06/02 06:00
PMCR- 2015/07/13
CRDT- 2011/03/24 06:00
PHST- 2011/03/24 06:00 [entrez]
PHST- 2011/03/24 06:00 [pubmed]
PHST- 2011/06/02 06:00 [medline]
PHST- 2015/07/13 00:00 [pmc-release]
AID - 10.1111/j.1528-1167.2011.03025.x [doi]
PST - ppublish
SO  - Epilepsia. 2011 Apr;52(4):810-5. doi: 10.1111/j.1528-1167.2011.03025.x. Epub 2011 
      Mar 22.