Warning on high dose simvastatin treatment

The latest Medicines Safety Update advises health professionals that the 80 mg daily dose should only be used in patients with a high risk of cardiovascular complications if they have not achieved treatment goals on lower doses and when the benefits outweigh the risks.

The recommendation is based on a reanalysis of data by the US Food and Drug Administration, showing higher doses of simvastatin are associated with increased risk of myopathy and rhabdomyolysis.

The TGA also warned that giving simvastatin concomitantly with potent CYP3A4 inhibitors such as gemfibrozil, cyclosporine or danazol was now contraindicated. 

Health professionals should advise patients of the risk of myopathy and remind them to report promptly any unexplained muscle pain, tenderness or weakness, the update said.