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New Statin Labels Needed, Stat!


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New Statin Labels Needed, Stat!

The U.S. Food & Drug Administration has determined that new information is needed on the product labels for statins, Gastroenterology & Endoscopy News reports.

One of the changes suggested by the FDA stems from the interactions between specific statins and hepatitis C virus and HIV protease inhibitors. When taken together, blood levels of statins could be elevated and increase the risk for muscle injury. The product labels of a particular statin, lovastatin, has been updated with new contraindications and dose limitations to prevent the risk of myopathy and rhabdomyolysis.

"Additionally, statin labels have been revised to eliminate the need for routine periodic monitoring of liver enzymes in patients taking these drugs," the news source adds. "Instead, statin labels now recommend the use of liver enzyme tests before starting the drugs and as clinically indicated afterward."

The labeling of pharmaceuticals can be especially tricky because of the complexity of regulations regarding them. Manufacturers need to be cautious when finalizing label designs to avoid any unnecessary recalls.