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Zocor 80 mg Pills Found To Have An Increased Risk Of Causing Rhabdomyolysis And Myopathy

FDA Issued This Warning In March 2010 About Zocor (Simvastatin) As Well As Vytorin And Simcor, Both Of Which Contain Simvastatin

UPDATE: June 2011 FDA Warning About 80 mg Dose Of Zocor, Simvastatin, And Vytorin Cholesterol Medications

Highest Simvastatin Dosage Linked To Potentially Fatal Rhabdomyolysis Muscle Injury And Kidney Failure

On June 8, 2011 the FDA announced dosing restrictions for pills containing 80 milligrams (mg) of simvastatin due to the determination these cholesterol drugs are associated, or linked, with an increased risk of developing myopathy and rhabdomyolysis, the latter medical condition a serious muscle injury usually requiring hospitalization, and that could lead to kidney failure, and, possibly, death.  (Read more)

An FDA Drug Safety Communication, "Ongoing Safety Review of High-dose Zocor (simvastatin) and Increased Risk of Muscle Injury", was issued on March 19, 2010.

From that document we learned about the greater risk of developing muscle injury, including rhabdomyolysis, for patients when they are prescribed and use higher doses of the cholesterol-lowering medication Zocor (simvastatin). Rhabdomyolysis -- sometimes called "rhabdo" as its short name -- is the most serious form of myopathy and can lead to severe kidney damage, kidney failure, and sometimes death.

The highest dosage of Zocor is the 80 mg pill. Simvastatin, the active ingredient in Zocor, is also found in Vytorin (ezetimibe / simvastatin) and in Simcor (niacin extended-release / simvastatin).

From this March 2010 FDA warning about high-dose Zocor pills:

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 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. Damage to the kidneys from rhabdomyolysis can be so severe that patients may develop kidney failure, which can be fatal.

Another aspect of this March 2010 Zocor warning was related to the FDA's "Potential Signals of Serious Risks / New Safety Information Identified by AERS, Second Quarter 2009" list of drugs, which included an item concerning a drug interaction between Zocor (simvastatin) and Cardizem (diltiazem) causing myopathy.

As for this Zocor - Cardizem drug interaction, from the above March 2010 FDA Drug Safety Communication about Zocor, toward the very end of that document:

Moreover, FDA has requested that the sponsor of simvastatin change the product labeling to instruct healthcare professionals to avoid prescribing simvastatin doses greater than 40 mg daily when patients are taking the medication diltiazem, due to an increased risk for myopathy.

Our law firm is very familiar with statin-induced rhabdomyolysis cases, having been one of the first law firms involved with the Baycol litigation, starting in about 2000. Baycol was withdrawn from the market on August 8, 2001, after it was made known that the use of Baycol could cause rhabdomyolysis and a significant number deaths resulting from the use of Baycol had been reported to the FDA.

What is rhabdomyolysis?

Rhabdomyolysis is a rare but very serious condition. It occurs when muscles are damaged and muscle cell contents are released into the bloodstream. If not detected early and treated promptly, rhabdomyolysis may result in acute renal failure, kidney damage, or other organ damage which may be fatal.

What are the symptoms of rhabdomyolysis?

Patients who develop rhabdomyolysis can have several different symptoms, but most often complain about muscle aches involving their calves, back, or their entire body. In addition to this type of muscle pain, weakness, fever, nausea, vomiting, and passing of dark urine can occur.

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