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FDA Adds Diabetes Warning to Statin Label

Posted: Sunday, March 11, 2012

The FDA said that all statins must carry warnings about increased risks of elevated blood sugar and possible transient memory and cognition problems, but at the same time the agency removed a standing recommendation for routine liver function tests for patients taking the cholesterol-lowering drugs.
The FDA said the label changes apply to atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), lovastatin extended-release (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor). Despite the additional warnings, the FDA said it "continues to believe that the cardiovascular benefits of statins outweigh these small increased risks." And statins may cause drug-drug interactions for patients taking drugs to treat HIV/AIDS or hepatitis C, according to a new statin warning from the FDA.

The FDA said that protease inhibitors taken with atorvastatin, rosuvastatin, simvastatin, or lovastatin increase the concentration of statins in the blood, which increases the risk for muscle injuries, including risk for rhabdomyolysis, which can cause permanent damage to the kidneys.

Specifically, the agency said atorvastatin is contraindicated with tipranavir plus ritonavir, and telaprevir and should be used with caution -- at the lowest effective dose -- among patients taking lopinavir plus ritonavir.

The agency singled out atorvastatin (Lipitor), rosuvastatin (Crestor), and simvastatin (Zocor) for the new warnings and restated a warning about mixing lovastatin (Mevacor) with HIV and HCV drugs.

For patients taking darunavir plus ritonavir, fosamprenavir, forsamprenavir plus ritonavir, or saquinavir plus ritonavir, the atorvastatin dose should be limited to 20 mg daily. In patients taking nelfinavir, daily atorvastatin should not exceed 40 mg. Rosuvastatin should be limited to 10 mg daily in patients taking atazanavir with or without ritonavir or lopinavir plus ritonavir. The FDA said simvastatin -- like lovastatin -- is contraindicated in patients taking "HIV protease inhibitors, boceprevir or telaprevir."

Also, rather than regular monitoring of liver function, the agency said that clinicians should now simply order a liver function test before starting a patient on a statin. Although the drugs do carry a risk of liver damage, the agency has judged the risk to be "rare and unpredictable in individual patients."

The diabetes warning has been rumored as a possibility since the findings from the JUPITER trial of rosuvastatin revealed an unexpected 27% increase in new onset diabetes among patients randomized to the statin.

That finding was especially perplexing because JUPITER was a study of statins in patients who had no history of cardiovascular disease, the so-called healthy patient trial. Moreover, based on the JUPITER results, the FDA approved rosuvastatin for primary prevention.

The FDA said hyperglycemia was also observed among patients treated with 40-mg atorvastatin in a substudy of PROVE-IT TIMI 22, and 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 data are a bit sketchier and rely mainly on post-marketing adverse event reporting. The FDA said 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."

In addition to those broad label changes, the FDA added a number of restrictions to the lovastatin (Mevacor) label, including a list of 10 drugs or drug classes that are contraindicated with lovastatin.

Drugs contraindicated with lovastatin include: Itraconazole, Ketoconazole, Posaconazole, Erythromycin, Clarithromycin, Telithromycin, HIV protease inhibitors, Boceprevir, Telaprevir, and Nefazodone.

Additionally, the new lovastatin label states that cyclosporine and gemfibrozil should be "avoided" when taking lovastatin, and lovastatin dosing should be limited to 20 mg for patients taking danazol, diltiazem, or verapamil. Finally, patients taking amiodarone should limit lovastatin to 40 mg daily.

In general, cardiologists applauded the FDA action -- particularly the decision to remove the requirement for liver function testing. But others worried about patients being scared off statins by the diabetes and memory warnings.

Harlan Krumholz, MD, of Yale University, stated that, "All drugs have side effects and rarely some patients will have an odd reaction to statins -- cognitive effects are among those, which are usually mild and resolve with stopping the medication. The blood sugar and diabetes issue has emerged over the last couple of years -- this appears to be a side effect."

Scott Grundy, MD, of the University of Texas Southwestern Medical Center in Dallas, was dubious about the level of evidence linking diabetes and cognition problems with statins. "I do not believe there is enough hard evidence to justify information and warnings about memory loss and confusion or increase in blood sugar." And Grundy, too, worried about the impact on patients, writing "I also think that these warnings will cause some people who need statins to stop taking them. That would be unfortunate."

The Cleveland Clinic's Steven Nissen, MD, often a critic of the FDA, stated that, "These are reasonable and prudent recommendations. I am pleased that FDA did not overstate the diabetes and cognitive function risks. Both problems are uncommon and don't diminish the importance of statins in cardiovascular protection. For the vast majority of patients, the benefits far outweigh the risks."

Source:, FDA's Consumer Update page, February 27, 2011.

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