High doses of Zocor can cause muscle damage: FDA
WASHINGTON – The FDA says chances of developing serious muscle injury increases at higher doses of cholesterol lowering drug Zocor (Simvastatin.)
“Based on review of data from a large clinical trial and data from other sources, the U.S. Food and Drug Administration (FDA) is informing the public about an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the “statin” class,” said the FDA on Saturday.
The clinical trial data being reviewed is from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial. The agency is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury.
The muscle injury, also called myopathy, is a known side effect with all statin medications. Patients with myopathy generally have muscle pain, tenderness or weakness, and an elevation of a muscle enzyme in the blood (creatine kinase). The higher the dose of statin used, the greater the risk of developing myopathy. The risk of myopathy is also increased when simvastatin, especially at the higher doses, is used with certain drugs.
“The most serious form of myopathy is called rhabdomyolysis. It occurs when a protein (myoglobin) is released as muscle fibers break down. Myoglobin can damage the kidneys as they filter blood out of the body. Patients with rhabdomyolysis may have dark or red urine and fatigue, in addition to their muscle symptoms,” said the FDA.
“ Damage to the kidneys from rhabdomyolysis can be so severe that patients may develop kidney failure, which can be fatal,” it said.
Known risk factors for developing rhabdomyolysis include age (> 65 years), low thyroid hormone levels (hypothyroidism), and poor kidney function. Myopathy and rhabdomyolysis are listed as possible side effects in the simvastatin and other statin drug labels.
Healthcare professionals should:
- Understand that rhabdomyolysis is a rare adverse event reported with all statins.
- Be aware of the potential increased risk of muscle injury with the 80 mg dose of simvastatin compared to lower doses of simvastatin and possibly other statin drugs.
- Follow the recommendations in the simvastatin label regarding drugs that may increase the risk for muscle injury when used with simvastatin (see Simvastatin Dose Limitations below).
Patients should:
- Not stop taking simvastatin unless told to by their healthcare professional.
- Talk to their healthcare professional about any questions they have about the use of simvastatin.
- Call their healthcare professional if they experience any of the following: muscle pain, tenderness or weakness, urine that is dark or red-colored, or unexplained tiredness.
*Simvastatin is sold as a single-ingredient generic medication and as the brand-name, Zocor. It is also sold in combination with ezetimibe as Vytorin; and niacin as Simcor.
Additional Information for Patients
Patients currently using 80 mg simvastatin should:
- Know that rhabdomyolysis is a rare side effect reported with all statin medications.
- Not stop taking simvastatin unless told to by their healthcare professional.
- Review their medical history and current medications with their healthcare professional to determine if they should continue using simvastatin.
- Talk to their healthcare professional about any questions or concerns they have about simvastatin.
- Call their healthcare professional if they have muscle pain, tenderness or weakness, dark or red colored urine, or unexplained tiredness.
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on Mar 20 2010. Filed under Health.
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On November 18, 2004, Dr. David Graham, associate director in the FDA’s Office of Drug Safety gave senate testimony that Crestor was one of five drugs with safety concerns. The drug causes muscle breakdown and renal failure. Now we hear the same for Zocor.
The truth is that women don’t benefit from Zocor, Crestor, Lipitor or any other statin drug for elevated cholesterol. There are no statin trials with even the slightest hint of a mortality benefit in women, and women should be told so. In other words, statin drugs don’t work for women.
In the elderly, a lower cholesterol level is associated wih higher mortality. This is demonstrated in many medical studies.
Jeffrey Dach MD