By: Mohamed Dungersi<\/p>\n
–<\/p>\n
On February 28, the U.S. Food and Drug Administration (FDA) approved important safety label changes for the class of cholesterol-lowering drugs known as statins.\u00a0 Aligned with the FDA\u2019s goal to provide the public with more information for the safe and effective use of statins, the agency made several modifications to the sections on liver enzyme monitoring, adverse events, and drug interactions.<\/p>\n
Previously, when patients were prescribed statin medications, their liver enzymes required routine monitoring (for instance, every three months).\u00a0 The FDA revised the label to remove the need for this monitoring.\u00a0 The labels now recommend that prescribers should perform liver enzyme tests before starting statin therapy and \u201cas clinically indicated thereafter.\u201d\u00a0 If serious liver injury with clinical symptoms and\/or hyperbilirubinemia or jaundice occurs during treatment, prescribed should interrupt the therapy.\u00a0 If there is no alternate etiology for these symptoms, prescribers should not restart the statin medication.<\/p>\n
The rationale behind the abovementioned change, based on the FDA\u2019s conclusion, is that serious liver injury with statins is rare and unpredictable in individual patients.\u00a0 The routine periodic monitoring of liver enzymes did not appear to be effective in detecting or preventing serious liver injury.<\/p>\n
The FDA also revised information about the potential for generally non-serious and reversible cognitive side effects, such as memory loss, confusion, forgetfulness, and amnesia.\u00a0 It also added increased blood sugar and glycosylated hemoglobin (HbA1c) levels in the revised labels.\u00a0 These reported symptoms are generally not serious, and are reversible upon statin discontinuation.\u00a0 They have variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).\u00a0 The FDA also states that the cardiovascular benefits of statins outweigh these small increased risks.<\/p>\n
The third major change was to the lovastatin drug label.\u00a0 The FDA updated the label with new contraindications and dose limitations.\u00a0 For instance, when patients take lovastatin with certain medicines, the combination can increase the risk for myopathy\/rhabdomyolysis (see\u00a0following table).<\/p>\n
Lovastatin Dose Limitations<\/b><\/p>\n Previous lovastatin label<\/b><\/p>\n<\/td>\n New lovastatin label<\/b><\/p>\n<\/td>\n<\/tr>\n \u00b7\u00a0Erythromycin, Clarithromycin, Telithromycin<\/p>\n \u00b7\u00a0HIV protease inhibitors<\/p>\n \u00b7\u00a0Nefazodone<\/td>\n \u00b7\u00a0Erythromycin, Clarithromycin, Telithromycin<\/p>\n \u00b7\u00a0HIV protease inhibitors<\/p>\n \u00b7\u00a0Boceprevir, Telaprevir<\/p>\n \u00b7\u00a0Nefazodone<\/td>\n<\/tr>\n \u00b7\u00a0Other fibrates<\/p>\n \u00b7\u00a0Lipid-lowering doses (\u22651 g\/day) of niacin<\/p>\n \u00b7\u00a0Cyclosporine<\/p>\n \u00b7\u00a0Danazol<\/td>\n \u00b7\u00a0Gemfibrozil<\/td>\n<\/tr>\n \u00b7\u00a0Diltiazem<\/p>\n \u00b7\u00a0Verapamil<\/td>\n<\/tr>\n \u00b7\u00a0Verapamil<\/td>\n\n\n
\n \n \n \n Avoid lovastatin with:\u00b7\u00a0Itraconazole, Ketoconazole<\/p>\n Contraindicated with lovastatin:\u00b7\u00a0Itraconazole, Ketoconazole, Posaconazole<\/p>\n \n Do not exceed 20 mg lovastatin daily with:\u00b7\u00a0Gemfibrozil<\/p>\n Avoid with lovastatin:\u00b7\u00a0Cyclosporine<\/p>\n \n Do not exceed 20 mg lovastatin daily with:\u00b7\u00a0Danazol<\/p>\n \n Do not exceed 40 mg lovastatin daily with:\u00b7\u00a0Amiodarone<\/p>\n Do not exceed 40 mg lovastatin daily with:\u00b7\u00a0Amiodarone<\/td>\n<\/tr>\n \n Avoid large quantities of grapefruit juice (>1 quart daily)<\/td>\n Avoid large quantities of grapefruit juice (>1 quart daily)<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n