FDA Announces Safety Changes in Labels on Statin Drugs

Treatment remains key to decreasing risk of heart disease.

By Merle Myerson, MD

Many people who have diabetes also have dyslipidemia, meaning that their lipid levels are too high (LDL cholesterol and triglycerides) or too low (HDL cholesterol—the “good” cholesterol). One group of medications used to treat dyslipidemia is statin drugs. These drugs, also known as Hydroxy-methylglutaryl coenzyme-A reductase inhibitors, work by blocking an enzyme needed for your body to make cholesterol. They lower LDL cholesterol and triglycerides as well as raise HDL cholesterol. They are also believed to have other benefits such as lowering inflammation.

The medications in the statin group are:

  • Lovastatin (Mevacor, Altoprev)
  • Atorvastatin (Lipitor)
  • Fluvastatin (Lescol)
  • Pitavastatin (Livalo)
  • Pravastatin (Pravachol)
  • Rosuvastatin (Crestor)
  • Simvastatin (Zocor)

Statins may also be part of combination products such as Lovastatin/niacin extended release (Advicor); simvastatin/niacin extended-release (Simcor); and simvastatin/ezetimibe (Vytorin).

On February 28, 2012, the FDA approved the following changes to the safety label for statins:

  • Routine monitoring of liver function tests no longer recommended
  • Possible increase of HbA1c and fasting blood glucose
  • Post-marketing reports of cognitive impairment
  • Lovastatin interactions: muscle soreness, myositis, rhabdomyolysis

The bottom line: From a risk/benefit point, the use of statin drugs (in combination with lifestyle modification) is still very much supported for the prevention of cardiovascular disease or the progression of existing disease, especially in people who have diabetes.

Here are some of my comments on the FDA label changes:

Liver function testing
LFTs should still be checked prior to starting a statin and thereafter as indicated.  If a person has liver disease – for example, Hepatitis C – more frequent testing may be necessary.

Note: The labeling does not address patients who are on combination therapy (a statin drug + a drug from another class of lipid medication) where there is less information available about side effects.

Possible increase in HbA1c and fasting glucose
The labeling change was based on the FDA’s interpretation of several studies of patients who were taking statin drugs. The overall risk of new onset diabetes is low and the benefits of statins outweigh the risks in people who do not have diabetes.

Cognitive Impairment
This was based on post-marketing reports and not on data from observational studies or clinical trials. Symptoms are generally not serious and reversible with cessation of statins. Further research and analysis regarding cognitive impairment needs to be done before concluding there is an association with statin use.

Lovastatin interactions
Information on drug interactions is similar to that recently issued for simvastatin. Some people take a supplement called  “Red Yeast Rice,” which actually contains/is the same substance as the prescribed lovastatin drug.

As always, it is important for people who are on statin drugs to check with their health care provider about these important changes and how they may affect you and your diabetes care.

Read Dr. Myerson's bio here.

Read more of Dr. Myerson's columns.

NOTE: The information is not intended to be a replacement or substitute for consultation with a qualified medical professional or for professional medical advice related to diabetes or another medical condition. Please contact your physician or medical professional with any questions and concerns about your medical condition.

Last Modified Date: November 28, 2012

All content on dLife.com is created and reviewed in compliance with our editorial policy.

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