HMGCoA reductase inhibitor (statin) drugs- Risk of immune-mediated necrotizing myopathy (IMNM) Label Changes
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – October 2012
*IMNM label change
WARNINGS AND PRECAUTIONS
- There have been rare reports of iimmune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with (statin) use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents.
- There have been rare reports of immune-mediated necrotizing myopathy associated with statin use.