COMPARATIVE PHARMACOVIGILANCE ANALYSIS OF BENZODIAZEPINE ANTICONVULSANT THERAPY AND SERIOUS SKIN EVENTS

Author(s)

Ali AK
Eli Lilly and Company, Indianapolis, IN, USA

OBJECTIVES: In late 2013, the FDA announced to the public that clobazam is linked to serious skin events, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), and consequently approved changes to clobazam label and medication guide. However, no comparative pharmacovigilance analysis was conducted for other anticonvulsant benzodiazepines, including clonazepam, clorazepate, diazepam, and lorazepam. This study aims to detect and clarify signals of serious skin reactions associated with benzodiazepine anticonvulsant therapy in the FDA Adverse Event Reporting System (FAERS). METHODS: Cases reported to FAERS between 1997 and 2012 were retrieved. The MedDRA Preferred Terms were used to define serious skin reactions. Individual anticonvulsant benzodiazepines were identified by generic names. Empirical Bayes Geometric Mean (EBGM) with 95% confidence interval (EB05-EB95) were calculated as disproportionality measures. Drug-event combinations with EB05≥2 were considered signals that warrant further review. RESULTS:

Conference/Value in Health Info

2014-05, ISPOR 2014, Palais des Congres de Montreal

Value in Health, Vol. 17, No. 3 (May 2014)

Code

PND1

Topic

Epidemiology & Public Health

Topic Subcategory

Safety & Pharmacoepidemiology

Disease

Neurological Disorders, Sensory System Disorders

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