If you’re one of the millions of Americans who take statins to prevent heart
disease, the Food and Drug Administration (FDA) has important new safety
information on these cholesterol-lowering medications.
FDA is advising consumers and health care professionals that:
Routine monitoring of liver enzymes in the blood, once considered standard
procedure for statin users, is no longer needed. Such monitoring has not been
found to be effective in predicting or preventing the rare occurrences of
serious liver injury associated with statin use.
Cognitive (brain-related) impairment, such as memory loss, forgetfulness and
confusion, has been reported by some statin users.
People being treated with statins may have an increased risk of raised blood
sugar levels and the development of Type 2 diabetes.
Some medications interact with lovastatin (brand names include Mevacor) and
can increase the risk of muscle damage.
This new information should not scare people off statins, says Amy G. Egan,
M.D., M.P.H., deputy director for safety in FDA’s Division of Metabolism and
Endocrinology Products (DMEP). “The value of statins in preventing heart disease
has been clearly established,” she says. “Their benefit is indisputable, but
they need to be taken with care and knowledge of their side effects.”
FDA will be changing the drug labels of popular statin products to reflect
these 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)
Crestor (rosuvastatin)
Lescol (fluvastatin)
Lipitor (atorvastatin)
Livalo (pitavastatin)
Mevacor (lovastatin)
Pravachol (pravastatin)
Zocor (simvastatin).
Products containing statins in combination with other drugs include:
Advicor (lovastatin/niacin extended-release)
Simcor (simvastatin/niacin extended-release)
Vytorin (simvastatin/ezetimibe).
Liver Injury Called Rare
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.
Egan explains that there had been signals in early clinical trials of
possible liver damage tied to statin use, so health care professionals were
advised to regularly test their patients’ liver enzyme levels. However, she
says, such damage is rare, and the tests are not effective at predicting or
preventing who will develop this rare side effect.
So FDA is now recommending that liver enzyme tests be performed before statin
treatment begins and then as needed if there are symptoms of liver damage.
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.
What should patients do if they fear that statin use could be clouding their
thinking? “Talk to your health care professional,” Egan says. “Don’t stop taking
the medication; the consequences to your heart could be far greater.”
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.
“Clearly we think that the heart benefit of statins outweighs this small
increased risk,” says Egan. But what this means for patients taking statins and
the health care professionals prescribing them is that blood-sugar levels may
need to be assessed after instituting statin therapy,” she says.
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.
If you’re one of the millions of Americans who take statins to prevent heart
disease, the Food and Drug Administration (FDA) has important new safety
information on these cholesterol-lowering medications.
FDA is advising consumers and health care professionals that:
Routine monitoring of liver enzymes in the blood, once considered standard
procedure for statin users, is no longer needed. Such monitoring has not been
found to be effective in predicting or preventing the rare occurrences of
serious liver injury associated with statin use.
Cognitive (brain-related) impairment, such as memory loss, forgetfulness and
confusion, has been reported by some statin users.
People being treated with statins may have an increased risk of raised blood
sugar levels and the development of Type 2 diabetes.
Some medications interact with lovastatin (brand names include Mevacor) and
can increase the risk of muscle damage.
