New statin labeling requirements: an overview.
As pharmacists advocate for appropriate use of medications to ensure safety and efficacy for patients, labeling requirements for medications should be considered before patients start new therapies or make changes to their current therapies. In early 2012, the Food and Drug Administration released new mandatory labeling requirements for HMG-CoA reductase inhibitors (more commonly known as "statins") regarding hepatic dysfunction, cognitive impairment, and glycemic control. These requirements are based on a combination of studies, adverse-event reporting databases, and literature reviews. Pharmacists should be prepared to advocate for patient safety and be ready to inform patients and other health care providers of the new labeling requirements and the role pharmacists can play in altering current statin therapy.
School of Pharmacy, Union University, Jackson, Tennessee.
Megan R
MR
Hicks
Bethany L
BL
Murphy
D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology / Q000517:prevention & control; D003072:Cognition Disorders / Q000139:chemically induced / Q000517:prevention & control; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006943:Hyperglycemia / Q000139:chemically induced / Q000517:prevention & control; D010593:Pharmaceutical Services / Q000458:organization & administration; D010595:Pharmacists / Q000458:organization & administration*; D024382:Professional Role; D014481:United States; D014486:United States Food and Drug Administration
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors
AST/ALT = Aminotransferases; CV = Cardiovascular; Cardiovascular; Cognitive impairment; Elderly; FDA = Food and Drug Administration; FPG = Fasting plasma glucose; Fasting plasma glucose; Food and Drug Administration; HMG-CoA reductase inhibitors; LFTs = Liver function tests; Labeling changes; Labeling requirements; Liver function tests; Pharmacist; Statins