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John Hopkins

Warning for Zocor, Vytorin and Simcor Users

» Written by // June 9, 2011 //


Are you taking the cholesterol lowering drugs: Zocor, Vytorin or Simcor?

The Food & Drug Administration published a release recommending new safety criteria for high does simvastatin; which is a key ingredient in all these drugs:

“The FDA has revised the drug labels for simvastatin and Vytorin to include the new 80 mg dosing restrictions. The agency also revised the labels for simvastatin, Vytorin and Simcor to include new dosing recommendations when these drugs are used with certain medications that interact to increase the level of simvastatin in the body, which can increase the risk for myopathy. Patients who are unable to adequately lower their level of LDL-C on simvastatin 40 mg should not be given the higher 80 mg dose of simvastatin;  instead, they should be placed on an alternative LDL-C-lowering treatment(s).”

Do not stop taking these medications if you are already on them. Instead, call your physician and discuss this new report with him or her. The FDA reports that most patients, who have been on these drugs for 12 months or more, show a low incidence of myopathy damage from them.

Myopathy is a condition that affects muscle tissue and causes damage resulting in weakness, inflammation, spasms, or paralysis. A common cause of myopathy is dehydration, which many of us have experienced secondary to extreme exercise; particularly in hotter climates.

Progressed myopathy is called rhabdomyolysis and is the most serious form of myopathy. Rhabdomyolysis can lead to severe kidney damage, kidney failure, and sometimes death.

It has been estimated that approximately 2.1 million patients have been prescribed simvastatin containing drugs during 2010. The dangerous level of simvastatin, according to the FDA, is 80 mg or an amount in combination with other ingredients that may cause it to potentiate its effect in the body.

The Food & Drug Administration has provided the following additional information for patients:

Patients currently taking 80-mg simvastatin-containing medicines should:

  • Not stop taking their medicine unless told to by their healthcare professional.
  • Review their medical history with their healthcare professional, the currently prescribed dose of simvastatin, and a list of their other current medications to determine if the medicines they are taking are appropriate. Know that certain medications should never be taken with simvastatin.
  • Immediately contact their healthcare professional if they experience muscle pain, tenderness or weakness, dark or red colored urine, or unexplained tiredness.
  • Talk to their healthcare professional about any questions or concerns they have about simvastatin-containing medicines.
  • Report side effects from the use of simvastatin-containing medicines to the FDA MedWatch program.

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