Features May 2012 Issue

Understand the Warning Labels That Accompany Statins

New labeling requirements raise questions about diabetes and memory loss, but the benefits still appear to outweigh any risks.

Taking a statin may do much more than help you manage your cholesterol. Studies in the past year suggest that the widely prescribed medications may adversely affect cognitive function and blood glucose levels, while at the same time help to protect against inflammatory disease, prostate cancer and neurological diseases such as Parkinson’s and Alzheimer’s.

But it is the possible negative side effects of statins that prompted the U.S. Food and Drug Administration earlier this year to change the drugs’ warning label to reflect concerns about diabetes and cognitive dysfunction. The revised warnings note that statins may lead to memory problems or confusion, and they may contribute to elevated blood glucose levels.

However, a recommendation that statin users routinely have their liver enzymes monitored, which had previously been on the warning labels, was removed after research indicated that the risk of liver damage is rare.

Steven Nissen, MD, Chairman of the Department of Cardiovascular Medicine at Cleveland Clinic, acknowledges that statins can slightly raise blood glucose levels in some individuals. And if a patient’s glucose level was already elevated, the bump associated with statin use could be enough to push them across the threshold defined as diabetes.

“The benefits of statins in protecting against heart attack, stroke and death are the same in those people whose blood glucose levels increase as they are in anyone else,” Dr. Nissen says. “Weight loss alone will help normalize blood glucose very quickly in many of these people.”

Who Benefits?
While statins are a proven weapon against high cholesterol and its effects on vascular health, Dr. Nissen admits that the drugs are not for everyone.

Some people believe that statins should be taken by most adults, regardless of their risks for heart disease. Dr. Nissen and most doctors agree that such a powerful medication should be used only in patients in need of cholesterol management. Dr. Nissen refers to the “worried well” individuals who have no major cardiovascular risk factors, but feel compelled to take statins for prevention only.

Because all medications have an effect on the body and may interact with other drugs and supplements people take, they should be prescribed with caution.

“This is another reason we should just be giving statins to the right people,” Dr. Nissen says. “It’s critical that people go over with their physicians just what their risk factors are and what benefits statins or any medication are supposed to provide them.”

Possible Side Effects
Among the more common side effects of statins is muscle ache, particularly in the legs. Just as statins affect your liver’s production of cholesterol, they may also influece muscle enzymes that result in muscle pain or discomfort. Any type of side effect you suspect is due to statin therapy should be reported to your doctor.

This is also true of memory lapses or feelings of confusion following statn use.

Dr. Nissen notes that the research used to support the label changes relating to cognitive changes did not come from randomized clinical trials.

“It’s not terribly well-documented, but the FDA felt compelled to issue its warning,” he says. “We do know that the effects are entirely reversible once you stop taking the statin.”

Removing the possible liver damage warning from the label may also encourage patients who had been hesitant to start taking statins to begin statin therapy. Patients had been advised to undergo routine periodic monitoring of liver enzymes, however officials found this approach to be ineffective in detecting the rare liver injuries that can be traced to statin use. If your doctor does suspect signs of liver injury, jaundice or other problems with liver function, you may be advised to suspend your statin use.

Statin Advice
If your doctor is reluctant to put you on a statin, but you feel your risk factors indicate you’d benefit from the drug, discuss his reservations and consider getting a second opinion. The same is true if your doctor is pushing statins, but your cholesterol is under control.

Worries about statin risks should also be shared with your doctor, but if your cholesterol is under control, and you’re not experiencing side effects from the drugs, don’t be in a hurry to stop your statin therapy.

“If you’re taking statins for the right reasons, there’s no reason to quit,” Dr. Nissen says.