Serious statin‐associated myotoxicity and rhabdomyolysis in A boriginal and T orres S trait I slanders: a case series

Background Statins are associated with skeletal muscle adverse effects. These are generally considered mild and reversible, with more severe toxicity occurring rarely. There is little known regarding statin myotoxicity in A boriginal and T orres S trait I slander A ustralians who are at high cardiovascular risk and likely to receive statins. Aims To describe features of serious statin‐associated myotoxicity ( SSAM ) occurring in Indigenous A ustralians and increase awareness of this condition. Methods Observational case series of SSAM in A boriginal or T orres S trait I slanders. Cases were identified from personal clinical experience, referrals, reports to the T herapeutic G oods A dministration, medical literature, an Internet search and reports from a histopathology laboratory. Information was collected onto a standardised data collection form. Results Fifteen cases of serious myotoxicity in A boriginal or T orres S trait I slanders exposed to statins were identified from 2006 to 2012. The mean age was 55 (range 35–69). Painless weakness was the most common presentation. Interacting drugs were involved in seven cases. Biopsies were done in eight cases, three showed inflammatory polymyositis and five necrotising myositis. Three patients died and two had permanent severe disability. Resolution of symptoms after statin cessation was variable. Conclusions SSAM has occurred in the Indigenous A ustralian population with some fatalities. Awareness of the potential for SSAM is essential for early recognition and effective management to reduce probability of avoidable catastrophic harm. Safe, as well as effective use of medication, is essential for optimum health outcomes. Effective pharmacovigilance and therapeutic risk management are important for A boriginal and T orres S trait I slander A ustralians.