AstraZeneca’s Crestor Label Revised With Stronger Rhabdomyolysis Warnings
This article was originally published in The Pink Sheet Daily
Executive Summary
Labeling now emphasizes increased risk of rhabdomyolysis, especially at 40 mg dose, but FDA reaffirms that muscle toxicity is seen across the statin class and is not unique to rosuvastatin. Labeling also recommends caution in dosing in patients of Asian descent due to increased elevation in rosuvastatin exposure.
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