Regulatory Focus™ > News Articles > FDA Announces Safety Labeling Change for Statin Blockbusters

FDA Announces Safety Labeling Change for Statin Blockbusters

Posted 28 February 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration announced on 28 February that it is implementing "important safety changes to the labeling" of some of the most popular statin drugs on the market, including Lipitor, Crestor and Zocor.

FDA announced four changes to the labeling for the statin products:

  • FDA now recommends that liver enzyme tests should be performed before starting statin therapy, and as clinically indicated thereafter
  • Certain cognitive (brain-related) effects have been reported with statin use. Statin labels will now include information about some patients experiencing memory loss and confusion
  • Labels will now warn patients and providers about reports of Increases in blood sugar levels (hyperglycemia) and a small, increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus
  • Health care professionals should take note of the new recommendations in the lovastatin label. Some medicines may interact with lovastatin, increasing the risk for muscle injury (myopathy/rhabdomyolysis)

"[T]hese medications continue to provide an important health benefit of lowering cholesterol," said Mary Parks, M.D., director for the Division of Metabolism and Endocrinology Products in the Office of Drug Evaluation II in FDA's Center for Drug Evaluation and Research.

Statin products are used to lower low-density lipoprotein cholesterol when combined with diet and exercise.

Read more:

FDA announces safety changes in labeling for some cholesterol-lowering drugs 


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.