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U.S. Department of Health and Human Services

Safety

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Pravachol (pravastatin sodium) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2012

 

Summary View

 

WARNINGS AND PRECAUTIONS

Skeletal Muscle
  • Cases of myopathy, including rhabdomyolysis, have been reported with pravastatin coadministered with colchicine, and caution should be exercised when prescribing pravastatin with colchicine
Liver
  • There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including pravastatin. If serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs during treatment with Pravachol, promptly interrupt therapy. If an alternate etiology is not found do not restart Pravachol.

 

ADVERSE REACTIONS

Postmarketing Experience
  • Gastrointestinal: fatal and non-fatal hepatic failure

 

DRUG INTERACTIONS

  • Colchicine: The risk of myopathy/rhabdomyolysis is increased with concomitant administration of colchicine
  • Gemfibrozil: Due to an increased risk of myopathy/rhabdomyolysis when HMG-CoA reductase inhibitors are coadministered with gemfibrozil, concomitant administration of Pravachol 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, Pravachol should be administered with caution when used concomitantly with other fibrates
  • Niacin: The risk of skeletal muscle effects may be enhanced when pravastatin is used in combination with niacin; a reduction in Pravachol dosage should be considered in this setting

 

PATIENT COUNSELING INFORMATION

  • It is recommended that liver enzyme tests be performed before the initiation of Pravachol, and thereafter when clinically indicated. All patients treated with Pravachol should be advised to promptly report any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice