FDA updates advice on cholesterol-lowering drugs

The Food and Drug Adminstration (FDA) has issued new safety information about statin medications. Statins often are prescribed by doctors to lower cholesterol.

In a recent news release, the FDA announced:

Routine monitoring of liver enzymes in the blood, once considered necessary for people who take statin drugs, is no longer needed.
The FDA says monitoring has not been found to be effective in preventing or predicting the rare occurrences of serious liver injury associated with statin use. The FDA now recommends liver enzyme tests be performed before statin treatment begins and then as needed if there are any signs or symptoms of liver damage. Such symptoms may include unusual fatigue, loss of appetite, right upper abdominal discomfort, dark urine or yellowing of skin or whites of eyes. The FDA advises patients who have any of these symptoms to consult a health care professional.

Cognitive impairment, including memory loss, forgetfulness and confusion, has been reported by some statin users.
Amy G. Egan, M.D., an FDA deputy director for safety, says in the FDA news release that such reactions are rare, but that people affected reported feeling "fuzzy." Such symptoms generally disappeared within a few weeks after the patient stopped using the statin, the FDA says. The agency advises anyone who experiences such fogginess to talk to their health care professional. "Don't stop taking the medication; the consequences to your heart could be far greater," Egan says.

Statin users may have an increased risk of raised blood sugar levels and type 2 diabetes.
The FDA describes this risk as a small one. "Clearly we think that the heart benefits of statins outweighs this small increased risk," Egan says. However, Egan advises that blood-sugar levels may need to be assessed in patients after statin therapy begins.

Some medications can interact with lovastatin (brand names include Mevacor) and increase the risk of muscle damage.
Such injury, called myopathy, is characterized by unexplained muscle weakness or pain. FDA is revising the drug label for lovastatin to provide more information about which drugs should not be taken at the same time as lovastatin. The new label will also include information on the maximum dose of lovastatin that should be taken if these drugs cannot be avoided.

The FDA will be changing drug package inserts to incorporate the new information. Statins affected include:

• Altoprev (lovastatin extended-release)
• Crestor (rosuvastatin)
• Lescol (fluvastatin)
• Lipitor (atorvastatin)
• Livalo (pitavastatin)
• Mevacor (lovastatin)
• Pravachol (pravastatin)
• Zocor (simvastatin)

Products that contain statins in combination with other drugs include:

• Advicor (lovastatin/niacin extended-release)
• Simcor (simvastatin/niacin extended-release)
• Vytorin (simvastatin/ezetimibe)

Egan stresses the new information shouldn't scare people off statins.

"The value of statins in preventing heart disease has been clearly established," Egan adds. "Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects."

The new guidelines are posted on the FDA's Consumer Update page. For more information visit the FDA website and search for "statins."