Mirtazapine antidepressant therapy is associated with rhabdomyolysis risk

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Mirtazapine antidepressant therapy is associated with rhabdomyolysis risk
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Conference Papers
Ayad Ali
ISPOR 19th Annual International Meeting
Place of Publication:
New Jersey
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OBJECTIVES : Among other factors, the breakdown of skeletal muscle fibers (rhabdomyolysis) is a leading cause of acute kidney failure. While rhabdomyolysis is multifactorial in etiology, there has been a concern about the link between therapy with mirtazapine, a heterocyclic antidepressant and the condition. This analysis characterizes rhabdomyolysis signals for mirtazapine and other antidepressants. METHODS : Adverse event reports submitted for antidepressants between 1997 and 2012 were retrieved from the FDA Adverse Event Reporting System (FAERS). Reporting Odds Ratio (ROR) and corresponding 95%CI (ROR05-ROR95) were estimated as a measure of disproportional reporting of rhabdomyolysis for individual antidepressants, including mirtazapine. The MedDRA preferred term and drug generic names were used for event and drug measurement, respectively. Drug-event combinations with ROR05≥ 2.0 are deemed as signals that warrant further review. RESULTS : There were 1,178 rhabdomyolysis reports submitted for all antidepressants, 85 reports were for mirtazapine. Signals of rhabdomyolysis (ROR and 95%CI) were detected for mirtazapine (2.62, 2.2-3.13), clomipramine (2.64, 2.07-3.36), and trimipramine (4.6, 2.64-8.0). There was disproportional reporting of rhabdomyolysis for the following agents albeit signal threshold was not reached (1< ROR05< 2): amoxapine, maprotiline, amitriptyline, rasagiline, citalopram, escitalopram, fluvoxamine, milnacipran, and venlafaxine. As a class, antidepressants were not associated with rhabdomyolysis risk (1.28, 0.91-2.02). Disproportionality measures were found for heterocyclics (2.10, 1.53-3.0), tricyclics (1.52, 1.3-2.34), nonselective monoamino oxidase inhibitors MAOIs (0.78, 0.42-1.5), selective MAOIs (1.68, 0.9-3.2), selective serotonin reuptake inhibitors SSRIs (1.2, 1.0-1.5), serotonin-norepinephrine reuptake inhibitors SNRIs (1.08, 0.82-1.5), and other antidepressants (0.62, 0.43-1.1). CONCLUSIONS : Rhabdomyolysis is a potential risk associated with mirtazapine. In light of inherent limitations of spontaneous reporting systems, such as FAERS, signal evaluation activities in real-world data are required to further characterize rhabdomyolsysis risk in relation to mirtazapine and other antidepressant agents.
Collected for University of Florida's Institutional Repository by the UFIR Self-Submittal tool. Submitted by Ayad Ali.
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Suggested Citation: Ali AK. Mirtazapine antidepressant therapy is associated with rhabdomyolysis risk. Value in Health. May 2014; 17(3):A208 Abstract No. PMH1.

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University of Florida Institutional Repository
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University of Florida
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