Thursday, June 09, 2011


Yesterday, the US FDA issued a safety communication regarding the use of high dose simvastatin. On their review of the SEARCH ( Study of the Effectiveness of Additional Reduction in Cholesterol and Homocysteine ) data, they found an obvious increase incidence of myopathy and muscle problems in those patients given high dose ( simvastatin 80mg ) of simvastatin ( Zocor ). There were 52 cases of myopathy in the 80mg group compared to 1 in the 20 mg group, and 22 cases of rhabdomyolysis in the 80 mg group compared to non in the 20 mg group. These numbers are frightening as rhabdomyolysis is a serious condition that can result in renal failure and death.
FDA also caution the use of more the 20 mg of simvastatin in patients already on Norvasc, amiodarone, diltiazem and verapramil, meaning that simvastatin may interact with these drugs, and increase the incidence of muscle problems.
Thank God, I do not believe in super-lowering of LDL-C, and have no patients on simvastatin 80mg. Simvastatin is a commonly prescribed statin and norvasc and diltiazem are commonly prescribed calcium channel blockers.
When I read this, I thought that all of you should know, as muscle problems with statins are getting more common and the use of calcium channel blockers are also quite common. I am sure the FDA will require MSD ( maker of Zocor ), to edit their box labelling to reflect this concern.

No comments: