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Statin Link to Cognitive Problems, Memory Loss by FDA Shock to Seniors

New safety warnings also cite liver problems, risk of diabetes, drug interactions with lovastation; American Heart Association responds

Feb. 29. 2012 – Statins, the cholesterol-lowering drugs taken by millions of senior citizens for better cardiovascular health, have enjoyed a long ride of positive feedback on their benefits. Yesterday, however, the Food and Drug Administration sent shock waves through the elderly community with a caution that statins may be associated with cognitive problems and memory loss, a major fear for many seniors.

The changes in the safety labels for statins were not just limited to the added risk of cognitive problems, however. There were also cautions expressed in three other area: liver problems, blood sugar increase and reactions to other drugs mixed with the statin lovastatin.

 “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,” 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.

This new information should not scare people off statins, says Amy G. Egan, M.D., M.P.H., deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products (DMEP). “The value of statins in preventing heart disease has been clearly established,” she says. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”

 

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FDA will be changing the drug labels of popular statin products to reflect these new concerns. (These labels are not the sticker attached to a prescription drug bottle, but the package insert with details about a prescription medication, including side effects.)

The changes to the statin labels are:

   ● Cognitive Problems, Memory Loss, Confusion

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. These reports generally have not been serious and the patients’ symptoms were reversed by stopping the statin. However, patients should still alert their health care professional if these symptoms occur.

FDA Notes:

FDA says it has been investigating reports of cognitive impairment from statin use for several years. The agency has reviewed databases that record reports of bad reactions to drugs and statin clinical trials that included assessments of cognitive function.

The reports about memory loss, forgetfulness and confusion span all statin products and all age groups. Egan says these experiences are rare but that those affected often report feeling “fuzzy” or unfocused in their thinking.

In general, the symptoms were not serious and were reversible within a few weeks after the patient stopped using the statin. Some people affected in this way had been taking the medicine for a day; others had been taking it for years.

What should patients do if they fear that statin use could be clouding their thinking? “Talk to your health care professional,” Egan says. “Don’t stop taking the medication; the consequences to your heart could be far greater.”

   ● Liver Problems

The drug labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. FDA now recommends that liver enzyme tests should be performed before starting statin therapy, and as clinically indicated thereafter. FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect. Patients should notify their health care professional immediately if they have the following symptoms of liver problems: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-colored urine; yellowing of the skin or the whites of the eyes.

   ● Diabetes Risk

Increases in blood sugar levels (hyperglycemia) have been reported with statin use. The FDA is also aware of studies showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus. The labels will now warn healthcare professionals and patients of this potential risk.

FDA Notes:

Diabetes occurs because of defects in the body’s ability to produce or use insulin—a hormone needed to convert food into energy. If the pancreas doesn't make enough insulin or if cells do not respond appropriately to insulin, blood sugar levels in the blood get too high, which can lead to serious health problems.

A small increased risk of raised blood sugar levels and the development of Type 2 diabetes have been reported with the use of statins.

“Clearly we think that the heart benefit of statins outweighs this small increased risk,” says Egan. But what this means for patients taking statins and the health care professionals prescribing them is that blood-sugar levels may need to be assessed after instituting statin therapy,” she says.

   ● Lovastatin Reactions

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). For example, certain medicines should never be taken (are contraindicated) with Mevacor (lovastatin) including drugs used to treat HIV (protease inhibitors) and drugs used to treat certain bacterial and fungal infections.

FDA Notes:

Some drugs interact with statins in a way that increases the risk of muscle injury called myopathy, characterized by unexplained muscle weakness or pain. Egan explains that some new drugs are broken down (metabolized) through the same pathways in the body that statins follow. This increases both the amount of statin in the blood and the risk of muscle injury.

FDA is revising the drug label for Lovastatin to clarify the risk of myopathy. The label will reflect what drugs should not be taken at the same time, and the maximum lovastatin dose if it is not possible to avoid use of those other drugs.

 

Statins, when used with diet and exercise, help to lower a person’s “bad” cholesterol (low-density lipoprotein cholesterol).

The products include:
  ● Lipitor (atorvastatin),
  ● Lescol (fluvastatin),
  ● Mevacor (lovastatin),
  ● Altoprev (lovastatin extended-release),
  ● Livalo (pitavastatin),
  ● Pravachol (pravastatin),
  ● Crestor (rosuvastatin), and
  ● Zocor (simvastatin).

Combination products include:
  ● Advicor (lovastatin/niacin extended-release),
  ● Simcor (simvastatin/niacin extended-release), and
  ● Vytorin (simvastatin/ezetimibe).

Reporting side effects to the FDA is important, the agency says. Health care professionals and patients should report any side effects associated with statin use to FDA MedWatch program.

American Heart Association Reaction

“The FDA’s announcement on the label changes does not question the benefit of statins to lowering cholesterol, but it does provide patients and healthcare providers the most current information about the safe use of statins,” said Gordon F. Tomaselli, M.D., president of the American Heart Association.

“Not surprising, but important for practitioners with regard to routine liver function test screening, which is no longer recommended, but should be done at baseline and for symptoms. This will change practice although I will remain vigilant in people with prior history of liver disease, people who drink or who are taking multiple drugs metabolized by the liver.

"Also, the contraindications of use of in particular anti-HIV drugs with Mevacor (lovastatin) are important to reemphasize as is the known but infrequent increase in blood sugar in patients taking statins.”

Tomaselli says “while we recommend healthy people focus on prevention using lifestyle changes rather than drug therapy whenever possible, for some people, lifestyle changes aren’t enough. As with all therapies, the decision to use statins for primary or secondary prevention must include careful consideration of the risks and benefits, side-effects and cost. Working with your healthcare provider to be sure you’re doing what you need to do to stay healthy is the best approach.”

For more information on lowering your risk factors for heart disease and stroke, visit www.heart.org .

For more FDA information:

  >> FDA Drug Safety Communication: Important safety changes for the class of cholesterol-lowering statin drugs
  >> FDA Expands Advice on Statin Risks
  >> FDA Voice Blog

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