Statin Roundup: Label Changes and Safety Issues

The past year has seen numerous changes in labeling and concerns for safety issues with the cholesterol-lowering statin drugs, particularly lovastatin (Mevacor) and simvastatin (Zocor). A quick review of recent issues:

1. cognitive impairment has been reported by some statin users
2. increases in blood glucose and Type 2 diabetes are now associated with statin use
3. drug interactions leading to risk of myopathy and myalgia
4. contraindicated drugs: itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, cyclosporine, gemfibrozil
5. lovastatin dosing changes: no more than 40 mg daily of lovastatin when given with amiodarone and no more than 20 mg daily with verapamil, diltiazem
6. danazol contraindicated with simvastatin and lovastatin doses more than 20 mg daily
7. simvastatin dosing changes: no more than 20 mg daily of simvastatin when given with amiodarone, amlodipine or ranolazine and no more than 10 mg daily when given with verapamil or diltiazem
8. use caution when combining with fibrates or > 1 g/day of niacin
9. limit use of simvastatin 80 mg daily to those patients currently stable on that dose for more than one year
10. limit grapefruit juice to < 1 quart daily

The good news is a lifting of liver enzyme monitoring requirements. The FDA notes that routine monitoring has not shown to be a good predictor of liver damage with statins. Baseline LFTs are recommended then monitoring according to clinical concerns.

References:

1. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm293330.htm
2. http://www.fda.gov/Drugs/DrugSafety/ucm293101.htm
3. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm257884.htm
4. http://www.fda.gov/Drugs/DrugSafety/ucm256581.htm