There may soon be changes in the labeling of widely-used cholesterol-lowering drugs –STATINS sold in the country .
The US Food and Drug Administration (FDA) warned that patients taking statins may face a “small increased risk” of higher blood-sugar levels and diabetes.
Statins, when used with diet and exercise, help to lower a person’s “bad” cholesterol (low-density lipoprotein cholesterol). Statins include blockbusters like Lipitor (atorvastatin) – the world’s largest selling drug with annual sales of around $12 billion – and other brands and generic versions like simvastatin, pravastatin and rosuvastatin. The issue has been debated for years with several studies also conducted to research whether there was an increased risk of diabetes by taking statins.
The FDA wants drug companies to add these warnings on labels of these cholesterol-lowering drugs. The drugs regulator here is expected to follow suit within a few months in India too, experts say. There are over a dozen domestic companies including Ranbaxy, Dr Reddy’s, Cipla, Glenmark, Sun Pharma, Lupin, USV, Zydus and Torrent selling generic versions of the drug.
But the FDA said it also wants to assure users that these medications continue to provide an important health benefit of lowering cholesterol.