Skip to Content

Label Changes for:

Pravachol (pravastatin sodium)

July 2016

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

July 2016

ADVERSE REACTIONS

Postmarketing Experience
  • Musculoskeletal: addition of tendon disorder, polymyositis
  • Respiratory: addition of interstitial lung disease
  • Psychiatric: nightmare

DRUG INTERACTIONS

Clarithromycin and Other Macrolide Antibiotics (addition to subheading)
  • Other macrolides (e.g., erythromycin and azithromycin) have the potential to increase statin exposures while used in combination. Pravastatin should be used cautiously with macrolide antibiotics due to a potential increased risk of myopathies.

USE IN SPECIFIC POPULATIONS

  • PLLR Conversion; please refer to label.

PATIENT COUNSELING INFORMATION

Liver Enzymes (new subheading)
  • It is recommended that liver enzyme tests be performed …
Embryofetal Toxicity
  • Advise females of reproductive potential of the risk to a fetus, to use effective contraception during treatment, and to inform their healthcare provider of a known or suspected pregnancy.
Lactation
  • Advise women not to breastfeed during treatment with PRAVACHOL.
     

 

February 2012 

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

 

Hide