Label Changes for:
Lescol XL (fluvastatin sodium) Extended-Release Tablets
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2012
WARNINGS AND PRECAUTIONS
- It is recommended that liver enzyme tests be performed prior to the initiation of Lescol/Lescol XL, and if signs or symptoms of liver injury occur.
- There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including fluvastatin. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with Lescol/Lescol XL, promptly interrupt therapy. If an alternate etiology is not found do not restart Lescol/Lescol XL.
- Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including Lescol/Lescol XL.
- Gastrointestinal: pancreatitis, hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in liver, cirrhosis, fulminant hepatic necrosis, hepatoma, anorexia, vomiting, fatal and non-fatal hepatic failure.
- Gemfibrozil: Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are coadministered with gemfibrozil, concomitant administration of Lescol/Lescol XL with gemfibrozil should be avoided.
- Other Fibrates: Because it is known that the risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concurrent administration of other fibrates, Lescol/Lescol XL should be administered with caution when used concomitantly with other fibrates
- Niacin:The risk of skeletal muscle effects may be enhanced when Lescol is used in combination with lipid-modifying doses (≥1 g/day) of niacin; a reduction in Lescol dosage should be considered in this setting.
- Glyburide: Concomitant administration of fluvastatin and glyburide increased glyburide exposures. Patients on concomitant therapy of glyburide and fluvastatin should continue to be monitored appropriately.
- Colchicine: Cases of myopathy, including rhabdomyolysis, have been reported with fluvastatin coadministered with colchicine, and caution should be exercised when prescribing fluvastatin with colchicine.