Statin Side Effects – New FDA Warnings

The FDA recently announced that statin drugs, used by millions of Americans to lower cholesterol, must carry warnings on their labels about potential side effects. What does this mean for you?

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Possible Statin Side Effects: Memory Loss, High Blood Sugar, Diabetes

The Food and Drug Administration recently announced that statin drugs, used by millions of Americans to lower cholesterol, must carry warnings on their labels about the following potential side effects:

  • Memory loss and mental confusion
  • Risk of high blood sugar
  • Risk of being diagnosed with Type 2 diabetes

“The value of statins in preventing heart disease has been clearly established,” said Amy G. Egan, M.D., M.PH., deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”

By contrast, the effects of very healthy lifestyle like the Pritikin Program to prevent heart disease are all positive. With lifestyle changes, you don’t have to worry about negative side effects.

States cardiologist Ronald Scheib, MD, Medical Director of the Pritikin Longevity Center: “Statins have important benefits like lowering cholesterol and perhaps reducing the inflammation in blood vessel walls that are associated with the development of cholesterol-related plaque. But statins are drugs, and drugs, by their very nature, have both risks and benefits. It is wrong to assume that any drug is 100 percent ‘safe.’”

“Individualization of statin therapy is necessary,” continues Dr. Scheib. “For each patient, the decision-making process regarding the risk/benefit ratio must take into consideration several factors, including the occurrence of a previous coronary event and multiple risk factors. For many, the benefits of statins outweigh the potential negative side effects.”

Lifestyle Change – No Risks

One form of cholesterol-lowering therapy that is side-effect-free is lifestyle change, such as the food, fitness, and lifestyle program taught by the physicians, registered dietitians, and other faculty at the Pritikin Longevity Center. “The effects of the Pritikin Program are all positive. With lifestyle changes, you don’t have to worry about negative side effects,” notes Dr. Scheib.

Key lifestyle actions of the Pritikin Program for lowering total and LDL (bad) cholesterol levels:
  • Eat far fewer saturated fats (such as butter, palm oil, coconut oil, meat fats, and milk fats); trans fats (partially hydrogenated oils); and dietary cholesterol.
  • Eat far more fiber-rich foods, especially soluble fiber from food such as beans, yams, oats, barley, and berries.
  • Eat vegetable proteins (such as tofu and beans) in place of animal protein like meat and poultry.
  • Eat fewer refined sugars and refined grains (such as white flour).
  • Exercise regularly: 1) Aerobic exercise daily, a minimum of 30 minutes, alternating moderate-intensity days with vigorous-intensity days; 2) Full-body resistance routine two to three times weekly; and 3) Stretching exercises two to three times weekly.
  • Lose excess weight, especially belly fat.

The results of the Pritikin Program in improving cholesterol levels and overall heart-health have been documented in more than 100 studies in peer-reviewed publications. One major study found that among more than 4,500 men and women attending the Pritikin Center for three weeks, total cholesterol levels fell on average 23 percent. LDL bad cholesterol also fell 23 percent. (Sources: The New England Journal of Medicine and the Annals of Internal Medicine.)

The evidence of the value of the Pritikin Program in reducing heart disease risk factors like cholesterol and preventing heart disease is so strong that recently the Pritikin Program was approved by Medicare for Intensive Cardiac Rehabilitation.

For more information from the FDA regarding its new warnings about statins, go to:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm293330.htm


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