Simvastatin 80 mg




Until recently, simvastatin 80 mg has been the highest FDA approved dose of the medication for the treatment of high cholesterol. However, the recent simvastatin 80 mg warning from the FDA states that the highest dose should be prescribed only to patients who have been taking this dose for over 1 year without any signs of myopathy, one of the most severe simvastatin 80 mg side effects. Simvastatin 80 now is not admissible for new patients or those who have been taking the medication in lower doses but without satisfactory cholesterol lowering effect. In fact, simvastatin 80 mg is not the only dose of the medication restrictions were imposed on. Prescription guidelines for medium (simvastatin 40 mg) and lower doses of the medication were reconsidered as well. For example, simvastatin 20 mg is now the highest admissible dose for patients on Amlodipine and Ranolazine. Those who take amiodarone, verapamil, and diltiazem can only be prescribed simvastatin 10 mg. In addition, now simvastatin 80 mg in contradicted in patients taking certain antibiotics (clarithromycin, erythromycin, telithromycin), gemfibrozil, certain antifungal medications (ketoconazole, itraconazole, posaconazole), HIV protease inhibitors, cyclosporine, nefazodone, and danazol.

Simvastatin 80 mg Safety

Simvastatin 80 mg safety was questioned based on the results of 2 studies, also known as SEARCH (2010) and from A to Z (2004). The 2010 year study found that 80 mg is associated with increased risks of myopathy and rhabdomyolysis (which is natural, the higher the dose the higher the risk of side effects), which resulted in substantial dose limitations. Specifically, myopaphy incidence in patients on simvastatin 80 mg was 0.9% against 0.02% in those on simvastatin 20 mg. But doesn’t it seems only natural that side effects of simvastatin 80 mg occur more frequently than with lower doses? In fact, about 60% of myopathy cases were linked to a genetic variant that affects uptake of the nedication in the liver, resulting in increased simvastatin concentration in plasma . Strangely, another study called from A to Z was done back in 2004 which also found that simvastatin 80 mg dose may be not quite safe, However, for some reason it’s only now the FDA reacted.

However, many pharmacologists express their concerns about the new guidelines as a policy being targeted specifically against simvastatin. For example, Curt Furberg, MD, PhD, a pharmacologist at Wake Forest University, remarked that the effect of statins on muscle tissue is not new, and in concerns all statin medications, not just simvastatin.

In 2010 about 2.1 million patients in the US were prescribed simvastatin 80 mg. In March the same year, the FDA issues the first warning about the potential danger of simvastatin 80 mg. However, no dose limitations were applied at that time.

Naturally, such a decision will provide stronger incentive for physicians to prescribe more potent statins like Lipitor (atorvastatin) and Crestor (rosuvastatin). In addition, physicians are currently being strongly advised to switch to the above mentioned medications in the most popular medical periodicals. However, simvastatin 80 mg cost remains the lowest in the class of statin medications.