US FDA limits use of high doses of Simvastatin

Moneycontrol Bureau

The US Food and Drugs Administration has recommended that there should be limited use of high doses of cholesterol lowering drug Simvastatin as the highest approved dose of 80 mg increases the risk of muscle damage, particularly during the first 12 months of use.

"The agency is recommending that Simvastatin 80 mg be used only in patients who have been taking this dose for 12 months or more and have not experienced any muscle toxicity. It should not be prescribed to new patients," the FDA said in a statement.

Simvastatin, which is sold under the brand name Zocor is used together with diet and exercise to reduce the amount of bad cholesterol (low-density lipoprotein cholesterol or LDL-C) in the blood according to the US drug regulator.

Many Indian pharmaceutical companies including Cadila, Aurobindo Pharma, Dr Reddy