The U.S. Food and Drug Administration (FDA) is responsible for a lot of health-related issues. Among other responsibilities, the FDA issues warnings about medication side effects and problems. Recently, they released a new set of guidelines designed to help doctors and patients better manage the use of statins for treating high cholesterol. The following sections present information that can help you better understand these guidelines and how they affect you.

Cholesterol and Americans

Approximately one in three American adults have high levels of low-density lipoprotein (LDL) cholesterol. This type of cholesterol is commonly called “bad” cholesterol. As LDL levels in the blood rise, plaque settles on artery walls. Soon, the arteries become narrowed. Eventually, the arteries and vessels may become blocked entirely.

When left undiagnosed or untreated, high LDL numbers can become deadly. High LDL levels can cause coronary heart disease and high blood pressure. These conditions increase your risk for a major vascular event, such as a heart attack or stroke. For decades, doctors have tried to reduce cholesterol levels by prescribing medications and lifestyle changes.

Statin Drugs and Cholesterol

Diet and exercise can go a long way toward reducing cholesterol levels, but sometimes these measures are not enough. The most common high cholesterol treatment is a statin. Statin medications are designed to reduce LDL levels in the blood. For most people, statins safely lower LDL levels.

Once prescribed and started, most high cholesterol patients will need to take statins for the rest of their lives. Some people may be able to stop if they successfully lower their cholesterol levels through diet, weight loss, exercise, or some other means.

These medicines are not for everyone. In light of the possible side effects caused by these medicines, the FDA released new guidelines that can help patients and their physicians effectively monitor potential side effects and issues caused by statin medicines.

FDA’s Newest Guidelines

Cholesterol-lowering statin medications have a long history of successfully treating and lowering cholesterol levels. The longer people take statins, the more science learns about the possible side effects. That’s why the FDA recently released new guidelines for statin use. Decades of research and study revealed a few important issues.

The FDA’s advice to patients and healthcare professionals include:

  • a warning that statins may cause cognitive impairment. These issues include memory loss, confusion, and forgetfulness.
  • a notice that routine liver enzyme monitoring is no longer necessary. Liver enzyme tests were used for decades as a way to catch potential liver damage. However, the FDA has found that these checks are not effective. The new recommendation: doctors should perform a liver enzyme test before statin use begins. Then patients should be checked again if symptoms of liver damage appear.
  • a warning that people taking statins may experience increased blood sugar levels and may develop type 2 diabetes. People taking statins should have their blood-sugar levels checked regularly.
  • a warning that patients taking lovastatin, a type of statin medication, are at risk for muscle damage. Patients taking this type of medicine should be aware of this possible drug interaction.

Lifestyle Changes That Can Improve Your Cholesterol

In the fall of 2013, the American Heart Association (AHA) and the American College of Cardiology (ACC) updated their recommendations about statin medications. In addition to expanding the possible pool of people who may benefit from the medicine, they also updated lifestyle guidelines for patients with high cholesterol.


Individuals diagnosed with high cholesterol should try to get 40 minutes of aerobic exercise three to four times a week. Ideal activities include brisk walking, bicycling, swimming, or even dancing.


Good eating habits can also help reduce your risk of complications, may help lower your cholesterol, and can help prevent other conditions. The AHA and ACC recommend people eat at least four to five servings of both fruits and vegetables each day. People with high cholesterol should also aim to eat more whole grains, nuts, and low-fat dairy products. They should limit the amount of meat, poultry, and fish they eat to no more than six ounces per day.

People with high cholesterol should reduce their sodium intake. The average American eats 3,600 milligrams of sodium in a day. The AHA recommends that all Americans should aim to get that number down to no more than 1,500 milligrams per day.

Read Video Transcript »

Doctor’s Whiteboard: “High Cholesterol 101”

Cholesterol, and its role in the body, is one of the most misunderstood topics in the world of healthcare. You’ve likely read or watched numerous news reports about the dangers of cholesterol in your diet and how it can lead to heart disease. But that’s far from the whole story.

Cholesterol is a crucial building block of every cell in your body. It’s so important that your liver actually produces most of the cholesterol that you’ll ever need, regardless of your diet.

There are two main types of cholesterol. LDL, or low-density, cholesterol particles are a combination of fat and protein that travel through your bloodstream and deliver cholesterol to the tissues that need it, such as nerve cells. HDL, or high-density, cholesterol particles contain a much higher ratio of protein to fat, and their function is to scour the bloodstream, vacuuming up excess bits of cholesterol and returning those to the liver. HDL also helps keep the blood vessels and arteries clear, and that’s why it’s often referred to as “good” cholesterol.

Cholesterol can become dangerous when your body has too much LDL or “bad” cholesterol. These fatty particles can accumulate inside of blood vessels and form clogs, or plaques, which can lead to a heart attack.

For many people, it’s possible to control cholesterol levels by making changes to their diet, like avoiding saturated fats, and getting more exercise. However, since the liver produces roughly 75 percent of a person’s total cholesterol, lifestyle changes are not always effective. 

One of the key medications to treat high cholesterol is a class of drugs called statins. Statins work to block the production of cholesterol in the liver and have been shown to bring down LDL levels, boost HDL levels, and lower the risk of developing heart disease.

Statins, like any medication, have side effects and may interact with treatments for related conditions. People who are taking other medications, such as blood thinners, may be at risk for developing drug interaction side effects. Many medications are metabolized, or broken down, in the liver. For some people with elevated cholesterol, it sometimes makes sense to use a statin that breaks down outside of the liver where there is less of a chance for dangerous side effects.

The good news about cholesterol is that through a combination of diet, exercise, and working with your doctor, it’s possible to dramatically reduce your risk of heart disease. If you’d like to learn more about treating high cholesterol, take a look at the information we have here at Healthline or make an appointment with your doctor.