Generic substitution of antiepileptic drugs
What's a clinician to do?
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Summary
Generic substitution of antiepileptic drugs remains a controversial area without a clear consensus to guide clinicians. The US Food and Drug Administration (FDA) requires rigorous testing of generic products and states that all approved products are interchangeable. FDA studies involve single doses in normal subjects so may not represent the performance of generic products in people with epilepsy. Physician surveys, case reports, and retrospective pharmacy database analyses suggest that antiepileptic drug generic substitution is associated with more health problems and high switchback rates, but these studies have insufficient detail on seizure control and blood levels. Several ongoing prospective randomized trials with rigorous pharmacokinetic methods aim to provide more data for decision-making.
- © 2013 American Academy of Neurology
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The Nerve!: Rapid online correspondence
- LETTER RE: Generic substitution of antiepileptic drugs: What's a clinician to do?
- Khichar Shubhakaran, Dr. S.N. Medical College, Jodhpur, India, drkhicharsk@gmail.com
- ; Rekha Jakur Khichar, Dr. S. N. Medical College, Jodhpur, India
Submitted June 21, 2014 - AUTHOR RESPONDS: Generic substitution of antiepileptic drugs: What's a clinician to do?
- Michael Privitera, University of Cincinnati Neuroscience Institute, CincinnatiPrivitmd@ucmail.uc.edu
Submitted June 21, 2014 - LETTER RE: Generic substitution of antiepileptic drugs: What's a clinician to do?
- Nitin K. Sethi, New York-Presbyterian Hospital, New Yorksethinitinmd@hotmail.com
Submitted June 21, 2014 - AUTHOR RESPONDS: Generic substitution of antiepileptic drugs: What's a clinician to do?
- Michael Privitera, University of Cincinnati Neuroscience Institute, Cincinnatiprivitmd@ucmail.uc.edu
Submitted June 21, 2014
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