Merck announces changes to high-dose simvastatin prescribing information in the U.S.

Published on June 9, 2011 at 7:56 AM · 1 Comment

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced changes to the prescribing information in the United States for the highest dose of simvastatin, 80 mg, and the use of simvastatin with certain other medicines. Simvastatin is a cholesterol-lowering medicine developed by Merck (marketed as ZOCOR®) that is now widely available in generic form; simvastatin is also a component of VYTORIN® (ezetimibe/simvastatin), another cholesterol-lowering medicine from Merck. The revised U.S. prescribing information for ZOCOR and VYTORIN reflecting the changes regarding the 80 mg dose of simvastatin and the drug interaction updates are posted at www.merck.com.

The changes follow a U.S. Food and Drug Administration (FDA) review, announced by the agency in March 2010, of the risk of muscle injury (called myopathy, including its most serious form, rhabdomyolysis) with the highest dose of simvastatin. Merck has updated the U.S. prescribing information:

  • To limit the use of the high dose of simvastatin, 80 mg, which is taken by approximately 12 percent of U.S. simvastatin users, to patients who have been taking that prescribed amount chronically (e.g., for 12 months or more) without evidence of muscle toxicity; and, in addition,
  • To contraindicate and/or limit the dose of simvastatin when used with certain drugs where the combined use may increase the risk of myopathy and rhabdomyolysis.

These updates are described further below.

"Nothing is more important to Merck than the safety of our medicines and the well-being of the patients who take them," said Michael Rosenblatt, M.D., chief medical officer for Merck. "We are proud of the role that simvastatin plays along with a healthy diet for patients with high cholesterol and those at high risk for heart attacks and strokes. Many people who take simvastatin will not be affected by these label updates. We encourage those who think these changes might affect them to talk to their doctor. Patients should talk with their doctor before they stop taking any of their medicines. We are committed to communicating these changes to help physicians and their patients understand the updated recommendations for use of this important medicine."

As part of that commitment, Merck has launched a new website, www.simvastatininfocenter.com, with information for patients on these updates.

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Comments
  1. David Runyon David Runyon United States says:

    Today, my WSJ contained your release, your referenced site in the journal however, offered nothing! I would have expected some data reflecting minimum and maximum dosages, perhaps some information on what the actual results of the testing offered.
    I personally have experienced muscle difficulties using the higher statin dosages; reducing the dosage over several years to now 10 mg/day, while closely monitoring cholesterol levels. For me a long user 10 mg easily controls the problem. I have been using statins for over 10 years.
    djr

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