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

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.

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Correspondence to Beatrice A. Golomb.

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Conflict of interest

Alexis K. Messner and Hayley J. Koslik declare they have no conflict of interest and their efforts on this were unfunded. Beatrice A. Golomb is the executor of an estate (and will be among the beneficiaries) that includes some stock in drug companies that make statins. The estate lawyer has advised no changes be made to the portfolio until after distribution. Her effort on this project was unfunded. Keith B. Hoffman is a past employee of Advera Health Analytics, Inc. and is a stockholder and stock option holder in the company. Abril Verden is a current employee of Advera Health Analytics, Inc. and is a stock option holder in the company.

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Golomb, B.A., Verden, A., Messner, A.K. et al. Amyotrophic Lateral Sclerosis Associated with Statin Use: A Disproportionality Analysis of the FDA’s Adverse Event Reporting System. Drug Saf 41, 403–413 (2018). https://doi.org/10.1007/s40264-017-0620-4

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