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FDA Changes Zocor Dosing and Safety Recommendations

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The Food and Drug Administration is changing the safety label of the cholesterol lowering drug simvastatin, sold under the brand name Zocor, because the 80 milligram dose has been connected to an elevated risk of muscle injury or myopathy. Simvastatin, prescribed last year to nearly 2.1 million patients in the U.S. alone, is also sold as a ezetimibe combination drug called Vytorin and as a niacin combination called Simcor.

The FDA requested the label changes after reviewing the results of a seven-year clinical trial, other trail data and analyses of reported adverse events. The new labels will include revised dosing restrictions that include not prescribing the 80 milligram dose of simvastatin for new patients, as it is only to be prescribed for patients who have already been on the 80 milligram dose for a year or more and have suffered no muscle injury.

The new simvastatin recommendations also say that patients who are unable to meet their cholesterol goals at the 40 milligram dose should not be given a higher dose, instead they should use an alternative medication. The new labels will also list contraindications for certain medications that have been found to increase the risk of simvastatin side effects.

 

 

breakinglawsuitnews.com disclaimer: This article: FDA Changes Zocor Dosing and Safety Recommendations was posted on Thursday, June 9th, 2011 at 6:58 pm at breakinglawsuitnews.com and is filed under Defective Drug Lawsuits.

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