Statin label to carry diabetes warning
All statin labels will now include a warning about a small increased risk for elevated blood glucose levels and possible problems with transient memory and cognition, the FDA announced today.
The agency will also remove existing recommendations to perform routine liver function tests on all patients taking the cholesterol-lowering medications, after concluding, “serious liver injury with statin use is rare and unpredicatable.”
“We want health care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol,” Mary Parks, MD, of the FDA's Center for Drug Evaluation and Research, said in a press release.
Now clinicians need only perform liver enzyme tests before starting statin therapy and if a patient presents with symptoms of liver problems, including: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-colored urine; yellowing of the skin or the whites of the eyes.
The labeling changes apply to atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), lovastatin extended-release (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor).
The new diabetes warning comes after hyperglycemia was observed in a substudy of the PROVE-IT TIMI 22 clinical trial in which researchers noted elevated blood glucose levels among patients treated with 40-mg atorvastatin. Additional data from a meta-analysis of 13 statin trials "reported that statin therapy was associated with a 9% increased risk for incident diabetes."
Evidence to support the loss of memory and cognition with statins is less well defined and consists mostly of information from post-marketing adverse event reporting, according to the FDA. Most statin-associated memory impairment is reversible when the medication is discontinued.
In addition to these changes, the FDA has also modified labeling information for lovastatin (Mevacor), including a warning about the increased risk for myopathy and rhabdomylosis, and added a list of 10 contraindicated drugs or drug classes. These drugs include: itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir and nefazodone.