For the millions of Americans who take statins to prevent heart disease, there is big news about this class of drugs.
The Food and Drug Administration (FDA) has important new safety information on these cholesterol-lowering medications, and encourages people taking them to ask their doctor about potential risks, side effects and questions they may have.
Below are some highlights of the FDA statement. You can read the whole thing here: FDA Expands Advice on Statin Risks
FDA will be changing the drug labels of popular statin products to reflect new concerns. (These labels are not the sticker attached to a prescription drug bottle, but the package insert with details about a prescription medication, including side effects.)
The statins affected include:
Altoprev (lovastatin extended-release)
Products containing statins in combination with other drugs include:
Advicor (lovastatin/niacin extended-release)
Simcor (simvastatin/niacin extended-release)
Liver Injury Risk
FDA has found that liver injury associated with statin use is rare but can occur. Patients are advised to consult their health care professional if they have symptoms that include unusual fatigue, loss of appetite, right upper abdominal discomfort, dark urine or yellowing of the skin or whites of the eyes.
Statins work in the liver to reduce the production of cholesterol, a waxy substance that can form plaque on the walls of the arteries and keep the heart from getting the blood it needs.
Reports of Memory Loss
FDA has been investigating reports of cognitive impairment from statin use for several years. The agency has reviewed databases that record reports of bad reactions to drugs and statin clinical trials that included assessments of cognitive function.
The reports about memory loss, forgetfulness and confusion span all statin products and all age groups. Egan says these experiences are rare but that those affected often report feeling “fuzzy” or unfocused in their thinking.
In general, the symptoms were not serious and were reversible within a few weeks after the patient stopped using the statin. Some people affected in this way had been taking the medicine for a day; others had been taking it for years.
The Risk of Diabetes
Diabetes occurs because of defects in the body’s ability to produce or use insulin—a hormone needed to convert food into energy. If the pancreas doesn’t make enough insulin or if cells do not respond appropriately to insulin, blood sugar levels in the blood get too high, which can lead to serious health problems.
A small increased risk of raised blood sugar levels and the development of Type 2 diabetes have been reported with the use of statins.
The Potential for Muscle Damage
Some drugs interact with statins in a way that increases the risk of muscle injury called myopathy, characterized by unexplained muscle weakness or pain. Egan explains that some new drugs are broken down (metabolized) through the same pathways in the body that statins follow. This increases both the amount of statin in the blood and the risk of muscle injury.
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.