FDA Revises Safety Warnings for Statins

FDA Revises Safety Warnings for Statins

After years of complaints from statin users about side effects such as muscle pain, cramps and memory loss, the Food and Drug Administration has revised its safety warnings for the cholesterol lowering medication. Millions of Americans take statins daily to lower their risk of heart disease.

The FDA made the decision after reviewing databases that recorded bad reactions to statins during clinical trials. The safety warnings will be included in a pamphlet of information that patients receive each time a statin prescription is filled.

Patients have reported forgetfulness, confusion, and memory loss after taking statin products, and the side effects were reported by patients in all age groups. The experience is not widespread, but reports of feeling “fuzzy” and unable to concentrate were present in all patients, regardless of the amount of time they used statins.

With this new information, the FDA is advising health care professionals to routinely monitor patients for memory impairment, as well as other side effects that have been identified in patients who take statins.

The statins affected by the new information include:

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

Products containing statins in combination with other drugs include:

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

Statins can also interact with other medications, increasing the risk of a muscle injury called myopathy, which is characterized by muscle weakness, pain or cramps. The FDA says some drugs metabolize in the body through the same pathways that statins follow. That increases the amount of statin in the blood and the risk of muscle injury. The FDA is revising the drug label for Lovastatin to clarify the risk of myopathy. The label will reflect what drugs should not be taken at the same time, and the maximum Lovastatin dose if it is not possible to avoid use of those other drugs.

Despite the new warnings, the deputy director for safety in the FDA’s Division of Metabolism and Endocrinology Products said the concerns are not enough to be overly alarmed.

“The value of statins in preventing heart disease has been clearly established,” Amy G. Egan, MD, said. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects. This new information should not scare people off statins.”

Reports show that memory-loss symptoms were not serious and reversed within a few weeks of discontinuing use of the statins. The drugs containing statins have been known to cause liver injury in rare occurrences, and officials said while routine liver enzyme blood tests are no longer needed to monitor patients who take statins, doctors should continue to be alert to their patients’ blood sugar levels and the possible development of Type 2 diabetes, which has also been reported by users of statins.

The report might leave patients wondering what to do if they experience cloudy thinking, memory loss, or any other side effects. “Talk to your health care professional,” Dr. Egan said. “Don’t stop taking the medication; the consequences to your heart could be far greater.”

Statins are proven to reduce cholesterol in the blood, which is a waxy substance that causes plaque to form on the walls of arteries. Plaque diminishes the blood flow to the heart, and eventually closes an artery completely which could cause a heart attack.

Beside the possible memory loss, patients should watch for symptoms of elevated blood sugar, liver problems, and muscle weakness also known as myopathy. These symptoms can be triggered by the statin alone, or the interaction between a statin and another prescribed drug.

Authored by: Rhonda Donaldson

There is 1 comment for this article
  1. Yvon Bedard at 3:41 pm

    Great article, unfortunaly I still have to take to reduce my cholesterol