February 28, 2012 – The U.S. Food & Drug Administration (FDA) issued a press release today stating that it will be requiring all statin drugs to carry a new warning about the increased risk of elevated blood sugar and possible transient memory and cognition problems. The label changes will apply to atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), lovastatin extended-release (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor). In addition to being linked to increased blood sugar levels and cognitive problems, statin drugs have also recently been associated with muscle damage, myopathy, rhabdomyolysis and kidney failure.
Free Statin Drug Lawsuit Evaluation: If you or a loved one has suffered a serious injury after taking Lipitor, Zocor, Crestor or any other statin drug, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the statin drug and we can help.
What’s the Problem with Statin Drugs?
The new diabetes warning for statin drugs was prompted by findings from the so-called JUPITER trial involving Crestor, which found an unanticipated 27% increase in new onset diabetes among test subjects taking the drug. The findings are particularly troubling due to the fact that JUPITER was an analysis of statins in users who had no previous history of cardiovascular disease. Moreover, the FDA based its decision to approve Crestor for primary prevention from JUPITER results.
In addition to finding unexpected cases of diabetes, the FDA said that it also found hyperglycemia in patients who took 40-mg doses of Lipitor in a substudy of PROVE-IT TIMI 22. As well, a meta-analysis of data from 13 statin trials “reported that statin therapy was associated with a 9% increased risk for incident diabetes.”
The cognitive side effects are more vague and less pronounced among JUPITER test subjects, and rely mainly on post-marketing adverse event reporting. The FDA stated those reports “generally described individuals over the age of 50 years who experienced notable, but ill-defined memory loss or impairment that was reversible upon discontinuation of statin therapy.”
Do You Have a Statin Drug Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Lipitor, Zocor, Crestor, Simcor, and Vytorin lawsuits. We are handling individual litigation nationwide and currently accepting new muscle damage, myopathy, rhabdomyolysis and kidney failure cases in all 50 states.
Free Statin Drug Lawsuit Evaluation: If you or a loved one has suffered a serious injury after taking Lipitor, Zocor, Crestor or Simcor, you should contact our law firm immediately. You may be entitled to compensation by filing a statin drug injury suit and we can help.