- Mirtazapine antidepressant therapy is associated with rhabdomyolysis risk
- Physical Description:
- Conference Papers
- Ayad Ali
- ISPOR 19th Annual International Meeting
- Place of Publication:
- New Jersey
- Publication Date:
- May 19, 2014
- 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.
- Publication Status:
- General Note:
- Suggested Citation: Ali AK. Mirtazapine antidepressant therapy is associated with rhabdomyolysis risk. Value in Health. May 2014; 17(3):A208 Abstract No. PMH1.
- Source Institution:
- University of Florida Institutional Repository
- Holding Location:
- University of Florida
- Rights Management:
- All rights reserved by the source institution.
- System ID: