Statin-Associated Adverse Events

Abstract

Although statins are well tolerated, their widespread use has raised awareness of rare adverse events. For example, the United States Food and Drug Administration (FDA) has issued product label warnings about statin-associated myopathy, incident diabetes, and cognitive impairment. Additional statin-associated adverse effects include proteinuria, transaminitis, and hemorrhagic stroke. The underlying pathophysiology of these adverse events remains unclear, and thus little guidance exists on addressing these issues at the bedside. Although statin-associated myopathy is common, many patients eventually tolerate a statin – albeit at less than ideal doses. Incident diabetes remains difficult to predict, but high statin potency, increasing age, and preexisting diabetes risk factors may predispose patients. Cognitive impairment – described mostly in case reports – may resolve after discontinuation of the offending statin. Rosuvastatin is linked to dose-dependent proteinuria. Elevated transaminases are reversible and unlikely to cause severe consequences. History of cerebrovascular disease increases the risk of hemorrhagic stroke on statin therapy. Overall, a thorough understanding of statin-associated adverse events will help health care providers manage patients who develop these complications. Here, we review the evidence for several statin-associated adverse effects and the implications for clinical practice.