Amyotrophic Lateral Sclerosis Associated with Statin Use: A Disproportionality Analysis of the FDA’s Adverse Event Reporting System

Beatrice A. Golomb (), Abril Verden, Alexis K. Messner, Hayley J. Koslik and Keith B. Hoffman
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Beatrice A. Golomb: University of California, San Diego
Abril Verden: Advera Health Analytics, Inc.
Alexis K. Messner: University of California, San Diego
Hayley J. Koslik: University of California, San Diego
Keith B. Hoffman: Advera Health Analytics, Inc.

Drug Safety, 2018, vol. 41, issue 4, No 8, 403-413

Abstract: Abstract Introduction Apparent elevations in reporting of amyotrophic lateral sclerosis (ALS)-like conditions associated with statin use have been previously described from data obtained via US and European databases. Objective The aim of this study was to examine US FDA Adverse Event Reporting System (FAERS) data to compare reporting odds ratios (RORs) of ALS and ALS-like conditions between statins and other drugs, for each statin agent. Methods We assessed for disproportional rates of reported ALS and ALS-related conditions for each statin agent separately by using the ROR formula. FAERS data were analyzed through September 2015. Results RORs for ALS were elevated for all statins, with elevations possibly stronger for lipophilic statins. RORs ranged from 9.09 (6.57–12.6) and 16.2 (9.56–27.5) for rosuvastatin and pravastatin (hydrophilic) to 17.0 (14.1–20.4), 23.0 (18.3–29.1), and 107 (68.5–167) for atorvastatin, simvastatin, and lovastatin (lipophilic), respectively. For simvastatin, an ROR of 57.1 (39.5–82.7) was separately present for motor neuron disease. Conclusion These findings extend previous evidence showing that significantly elevated ALS reporting extends to individual statin agents, and add to concerns about potential elevated occurrence of ALS-like conditions in association with statin usage.

Date: 2018
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DOI: 10.1007/s40264-017-0620-4

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