COMMENTARY | Like millions of Americans I take a statin to prevent heart disease. That’s why the Food and Drug Administration’s just-released expanded advice on these cholesterol-lowering drugs quickly got my attention.
The FDA will be changing the labeling for specific statins, including Altoprev, Crestor, Lescol, Lipitor, Livalo, Mevacor, Pravachol and Zocor to reflect concerns about memory loss, increased risks for Type 2 diabetes, and drug interactions that could increase the risk of muscle damage. Labeling will also be changed for products containing statins in combination with other drugs, such as Advicor, Simcor, and Vytorin.
In addition, the FDA is advising that monitoring liver enzymes in the blood, once considered standard procedure, is no longer necessary.
Memory Loss
Reports of memory loss, forgetfulness and confusion have been associated with all statin products and all age groups. Amy G. Egan, MD, MPH, deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products, says these experiences are rare, but that those who are affected report feeling “fuzzy” or unfocused in their thinking.
In general, reports Egan, the symptoms were not serious and were reversible within a few weeks after patients stopped taking the statin. Egan advises patients who fear that statin use may be clouding their thinking to consult their doctor. She also cautioned: “Don’t stop taking the medication; the consequences to your heart could be far greater.”
Risks for Diabetes
Small increases in blood sugar levels (hyperglycemia) have been reported with statin use along with the risk of developing Type 2 diabetes.
“Clearly, we think that the heart benefit of statins outweighs this small increased risk,” says Egan. “But,” she adds, “what this means for patients taking statins and the health care professionals prescribing them is that blood-sugar levels may need to be assessed before instituting statin therapy.”
Muscle Damage
The FDA is alerting health care professionals that such lovastatins as Mevacor may interact with other medications, increasing the risk of muscle damage. Specifically, drugs used to treat HIV and certain bacterial and fungal infections should never be taken in conjunction with a lovastatin.
Liver Monitoring No Longer Necessary
Routine periodic blood work to monitor liver enzymes is no longer recommended. The FDA has concluded that serious liver damage with statins is rare and that regular monitoring does not appear to be effective in detecting or preventing this infrequent side effect. The FDA does caution patients taking statins to contact their doctor immediately if they experience any of these signs of liver problems: unusual fatigue or weakness, loss of appetite, upper belly pain, dark-colored urine, or yellowing of the skin or the whites of the eyes.
The FDA’s intent in releasing this expanded safety information is to keep patients and health care professionals informed of statins’ low-level risks, while assuring them of the important heart benefits they provide.
“This new information should not scare people off of statins,” says the FDA’s Egan. “The value of statins in preventing heart disease has been clearly established. Their benefit is indisputable, but they need to be taken with care and knowledge of their side-effects.”
Source:
The Food and Drug Administration Consumer Update