FDA: Zocor Patients Should Understand Rhabdomyolysis Symptoms

High doses of Zocor® (simvastatin) have been linked to an increase in the risk of a serious muscle disease, rhabdomyolysis. Patients taking the cholesterol-lowering medication should be aware of the risk and should seek medical attention if they develop signs or symptoms of the disease.

The U.S. Food and Drug Administration (FDA) first warned patients and health care providers about a possible link between the 80 mg dose of Zocor® and rhabdomyolysis in 2010 after reviewing clinical trials, observational studies and reports of adverse events.

Then, in June 2011, the agency issued another Safety Communication, recommending that use of the 80 mg dose of Zocor® be limited to patients who have taken the dose for more than 12 months and who have not experienced muscle injuries. The FDA said in the communication that new patients should not be prescribed 80 mg of simvastatin.

Patients that are taking Zocor® should visit their doctors right away if they experience symptoms of rhabdomyolysis, including severe muscle aches, muscle weakness and dark-colored urine.

Rhabdomyolysis is a breakdown of the muscles that can lead to serious complications including kidney failure and death.

For more information, contact a Zocor® attorney today.

FDA OKs Cholesterol-Diabetes Pill

The U.S. Food and Drug Administration (FDA) on Oct. 7, 2011, approved a combined diabetes-cholesterol drug, according to Bloomberg.

The new pill combines the Type 2 diabetes medication Januvia® with the cholesterol drug Zocor®.  It is the first drug to combine medications that lower both cholesterol and glucose. The new medication is called Juvisync®.

Merck’s U.S. scientific director for diabetes and obesity Sethu Reddy said that three in four deaths in people with Type 2 diabetes are caused by cardiovascular disease.

“Hundreds of thousands of people in the U.S. with Type 2 diabetes may already be taking Januvia® and simvastatin [Zocor®] pills,” said Michael Davidson in an interview with Bloomberg.  Davidson is director of preventive cardiology at the University of Chicago Medical Center.

Fixed dose combinations of both drugs have been developed to meet the individual needs of different patients.

“High blood sugar and cholesterol issues are so intertwined, and diabetes and heart disease are so intertwined, that it makes sense to try to treat them simultaneously, as opposed to separately and individually,” Reddy said.

Last year Januvia® sold $2.39 billion worth of its medication and ® brought in $468 million.

FDA Says to Limit High Dosage Zocor

The U.S. Food and Drug Administration (FDA) published an update warning consumers and health care providers to curtail the use of the 80 mg dosage of simvastatin, sold under the brand name Zocor®. Statins such as simvastatin have been proven to decrease the occurrence of heart attacks and strokes.

Eighty milligrams is the highest dose available of the cholesterol-lowering drug, which also is sold as Vytorin® when combined with ezetimibe and as Simcor® when combined with niacin.

Only patients who have been taking simvastatin for 12 months or longer with no side effects should be taking it at the 80 mg level, the FDA said in the update. New patients should not be started at the 80 mg dose, and patients already on the medication should not have their dosage raised to the 80 mg level, the agency also noted.

The federal agency based its advisory on study data showing that the higher dose of the drug could cause rhabdomyolysis, a rare muscle-wasting disorder that can lead to kidney failure and death. Statins, which lower the “bad” cholesterol or LDL (low density lipoprotein) in the blood, can cause muscle weakness or pain, called myopathy, but when simvastatin or Zocor® is used at the highest 80 mg dose, clinical trials have shown that myopathy can progress to rhabdomyolysis.

Rhabdomyolysis is a breakdown of muscle tissue that releases toxic substances that can clog the tubules or structures in the kidneys. When this happens, the kidney tissue begins to die.

The risk for rhabdomyolysis is greater in patients on the high Zocor® dose, especially in those patients during their first year of treatment on the drug, the FDA said. Simvastatin often causes muscle damage in those who have been taking Zocor® in combination with certain other medications that tend to raise the level of the statin in the body.

The FDA revised the labels on the statin drugs, warning against using the higher dose of the drug or of combining it with certain other medications, which also are listed on the label.

Patients should not stop taking Zocor® or other simvastatin medications without first talking with their doctors, warned an FDA spokesman. However, you should contact your doctor if you have:

  • Muscle pain, tenderness, or weakness
  • Dark or red-colored urine
  • Unexplained fatigue

During the next year, the FDA said it will keep track of prescription data to see if the warnings to lower the 80 mg dosage have been heeded by doctors and patients.

If you’ve been diagnosed with a muscle side effect after being treated with the 80 mg dose of Zocor®, you might be eligible for financial compensation. Contact our Zocor® lawyers to learn more.

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