Important safety label changes for the class of cholesterol-lowering drugs known as statins has been approved by the U.S. Food and Drug Administration (FDA).
In rare cases, liver problems have occurred in some patients however, the statins’ labeling will no longer require the routine monitoring of patients’ liver enzymes. The new warnings also state an increase in blood sugar levels have been reported with statin use. There also will be a label change specific to lovastatin (Mevacor). Certain medicines interact with this particular statin, increasing the risk of myopathy, or muscle damage.
This is the first time the agency has officially linked statins with cognitive problems including confusion and memory loss, although many patients have reported these types of problems for years. The drugs affected by the label change include – Crestor, Lipitor, Vytorin and Zocor.
Patients are advised to talk to their medical doctors before making the decision to discontinue use or if they have noticed any problems or questions. The FDA MedWatch program should be used to report any side effects.
Detailed information can be found on the FDA Website.