Sacubitril/Valsartan and Rhabdomyolysis: Reanalysis of a Potential Safety Signal

Sunaga and Ryo 1 Sunaga T Ryo Y. Potential safety signals for rhabdomyolysis associated with high-potency statin use with or without sacubitril/valsartan. Am J Cardiol. 2022; 166: 127-130 Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar recently identified disproportionate reporting of rhabdomyolysis with the use of sacubitril/valsartan on the basis of postmarketing adverse event data submitted to the United States Food and Drug Administration Adverse Event Reporting System (FAERS) (proportional reporting ratio [PRR] 2.06, 95% confidence interval [CI] 2.01 to 2.12). Upon review, however, the results obtained and conclusions reached by the authors are somewhat perplexing, and attempts to replicate their findings were unsuccessful. Additionally, a lack of clear and consistent methodology casts doubt on the reliability of these data. It therefore seemed prudent to raise certain concerns given the potential for these findings to unduly influence future prescription of sacubitril/valsartan over fears related to skeletal muscle damage.