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Entries in Zocor (2)

Wednesday
Feb292012

FDA Announces New Warning Labels for Cholesterol Drug

iStockphoto/Thinkstock(WASHINGTON) -- Federal regulators announced on Tuesday they would add additional safety warnings to the labels on statins, a class of drugs that lower cholesterol.

Statins -- more commonly known by the brand names Lipitor, Crestor and Zocor -- inhibit the enzyme that plays a big part in the liver's production of cholesterol.

The U.S. Food and Drug Administration now requires that statin labels include warnings about the rare, but serious risk of liver damage, memory loss and confusion along with type 2 diabetes.  Certain statins, known by the generic name lovastatin, can raise the risk of muscle weakness.

The decision came following an internal meeting between the FDA's Office of Surveillance and Epidemiology and Office of New Drugs, according to Dr. Amy Egan, the FDA's deputy director of safety in the division of metabolism drug products.

Egan said most of the information reviewed, especially the effect of statins on memory loss, came from a small number anecdotal reports compiled over one year.  She added that the warning for memory loss was more for serious cognitive problems than simple forgetfulness.

"We can't establish causality with statin therapy," said Egan, regarding the new warnings.

Most of the studies the division evaluated were short-term studies, suggesting that the long-term effects of statin therapy were unclear.  Egan also said it had yet to be determined which statins and at what dose could increase the risk of the listed side effects.

Many experts said the added labels should not deter patients from statins.  Instead, they should report any side effects they experience to their physician.

Consumers will be able to see the label changes on their medications within the next 30 days, Egan said. ´╗┐

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Thursday
Jun092011

FDA Recommends Limits to High-Dose Zocor for Cholesterol

Keith Brofsky/Thinkstock(WASHINGTON) -- The U.S. Food and Drug Administration has recommended limiting high doses of a widely prescribed cholesterol-lowering drug called simvastatin -- commonly known as Zocor -- after reviewing the results of a clinical trial that found a higher risk of muscle damage compared to patients taking lower doses of the statin.

The use of the 80-mg dose of Zocor, the highest approved dose of the drug, can harm muscles and potentially cause deadly kidney damage, the U.S. Food and Drug Administration warned Wednesday.

More than 2 million Americans were prescribed the 80-mg dose of Zocor or another type of simvastatin in 2010, according to the FDA. Simvastatin is also sold as the combination statin drugs Vytorin or Simcor.

The most common side effects of Zocor include muscle pain, tenderness and weakness. While rare, more serious side effects include muscle damage that can lead to liver disease and kidney failure. Five out of every 100,000 people taking Zocor for a year experienced the effects, according to the FDA.

Statins, including Zocor, have been shown to dramatically lower bad cholesterol in patients with heart disease and diabetes. But many doctors say they've known long before this warning of its potential dangers. And, some said, an FDA recommendation for a warning label is a necessary next step.

About 13 million people in the United States take statins to lower cholesterol levels and reduce the risk of heart disease. Many doctors said they switch to other kinds of statins, including Crestor and Lipitor, if a patient required a higher dose. The drugs were not among those shown to raise the risk of muscle damage.

Only patients who have been taking the 80-mg dose for 12 months or longer without signs of muscle damage should continue to take Zocor, the FDA recommended.

Patients should not stop taking their medication unless told by a doctor to do so.

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