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Statin Side Effects

Statins are a class of drug that lower cholesterol levels in the blood. Statin side effects reportedly include an increased risk of cardiomyopathy and diabetes. Additionally, a link between statins and rhabdomyolysis has been reported.


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Statin Drugs

Statins lower a patient's blood cholesterol by reducing the amount of cholesterol the liver produces. By lowering the amount of cholesterol in the blood, statins are used to treat and prevent atherosclerosis, which can cause chest pain, heart attacks and strokes. Statins have reportedly been linked to an increased risk of rhabdomyolysis and cardiomyopathy.

Common side effects of statins include headache, nausea, vomiting, constipation, diarrhea, rash, weakness and muscle pain.

Drugs in the statin class:

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

Drugs that combine a statin with another drug:

Simcor (a combination of simvastatin and niacin)
Vytorin (a combination of simvastatin and ezetimibe)

Statin Issues

In October 2012, the FDA announced a change to the warning label of drugs in the statin class. That change was made to alert patients to the risk of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, a rare condition that is associated with statin use. Symptoms of IMNM include proximal muscle weakness and increased serum creatine kinase, both of which can continue after statin therapy has been discontinued.

In March 2012, the FDA announced a label change to alert patients to the risk of side effects and possible drug interactions linked to statin use. According to the FDA, there have been reports of muscle injury when statins are used with fibrates (cholesterol-lowering drugs), niacin (in large doses), Ranexa (used to treat angina), or Colchicine (used to treat gout).

The FDA also noted that there were reports of serious liver problems in patients who use statins. Although those reports are rare, the condition is serious. Symptoms of liver problems include tiredness or weakness, loss of appetite, upper belly pain, and dark-colored urine. Some patients have also experienced an increase in blood sugar levels.

Statins and Cardiomyopathy

Some statins have reportedly been linked to an increased risk of cardiomyopathy, a serious weakening of the heart muscle or a change in the structure of the heart muscle. Cardiomyopathy is associated with the heart's inability to pump blood adequately and other problems related to the function of the heart.

Statins and Diabetes

On February 28, 2012, the FDA announced that use of statins was associated with an increased risk of diabetes mellitus. Although the FDA said the risk is small, some critics argue that studies investigated by the FDA included statins that were not as potent as others. For every 167 people taking Crestor, for example, one person developed diabetes. That's compared with one in every 255 patients treated with a statin overall.

The JUPITER study (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) found that in certain patients, the risk for newly developed diabetes increased 25 percent in patients who used Crestor (a statin drug) over those who were given a placebo. Meanwhile, a meta-analysis of six statin studies showed the risk of new-onset diabetes increased by about 13 percent when patients were given a statin.

The FDA has not removed statins from the market, saying it believes the benefits of statin drugs continue to outweigh the risks.

Statins and Birth Defects

Women who are pregnant are cautioned against using statins because of the risk of adverse effects on the fetus.

Statin Side Effects Complaint

If you or a family member have taken a Statin and have experienced any side effects, please click the link below to submit your complaint.

Last updated on May-7-15


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