How Safe Are Statins?
Statins are the drugs of choice for treating high cholesterol and are used by millions of patients worldwide. While the accumulated safety record for statins is excellent, as with all drugs there are associated side effects in susceptible patients. Fortunately, serious safety issues, which include liver abnormalities and and muscle damage, are rare and are usually detected before critical problems develop. Expert groups such as the American Heart Association agree that the benefits of these drugs far outweigh the risks for the vast majority of patients.
History
Statin drugs block the synthesis of cholesterol in the liver and effectively lower the the level of LDL (bad) cholesterol. These drugs demonstrate impressive efficacy in reducing cardiovascular disease and mortality, and additional clinical uses in cancer, multiple sclerosis and other areas are under active investigation. However, as expected for such widely used drugs, there have been reports of safety concerns over their years of use.
Minor Side Effects
As with all drugs, statins have side effects. Most of these are relatively minor and often go away as the patient adjusts to the medication. These side effects include muscle pain, usually in the back, legs or jaw; nausea; diarrhea; and constipation.
More serious side effects of statins include liver abnormalities and muscle damage.
Liver Abnormalities
Statins elevate liver enzymes in approximately 1 percent of patients, usually within the first few months of therapy. Enzyme changes occur more frequently in elderly patients taking additional drugs that might interact with statins and in patients taking higher doses of statins. Elevated liver enzymes are usually not associated with any symptoms and are reversible upon discontinuation of the statin. However, this side effect has raised concerns about statin-induced liver failure, since occasional, but rare, reports of liver failure have appeared. Although no definite link has been established between statin use and liver failure after years of study, statins should not be used in patients with active or chronic liver disease.
Muscle Damage
In rare cases, statin-induced muscle breakdown can lead to release of muscle contents in the blood stream and development of rhabdomyolysis or rhabdo for short. If severe, rhabdo may cause kidney failure and death. This potential complication is monitored by checking creatine phosphokinase (CPK) enzyme levels in the blood. The major symptoms of rhabdo include profound muscle pain and bloody urine. Rhabdo occurs in 1 in 10,000 patients taking statins, although as with liver-enzyme changes, the risk increases in elderly patients taking other medications and in those taking higher doses of statins. In 2001, the statin Baycol was recalled from the market by its manufacturer after being implicated in over 60 deaths due to rhabdo. Since then, drug manufacturers have added a warning to statin advertising about the risk of unexplained muscle pain and weakness.
Conclusion
Statins control cholesterol levels in millions of patients. Serious side effects are rare, reflecting a favorable benefit to risk profile.The prevailing clinical view on statin safety is summarized by Dr. Janet Armitage, who published a large review on statin safety in the British medical journal Lancet in 2007. According to Amitage, "For most people, statins are safe and well-tolerated, and their widespread use has the potential to have a major effect on the global burden of cardiovascular disease".
Tags: side effects, patients taking, liver failure, muscle pain, abnormalities muscle, abnormalities muscle damage, cardiovascular disease