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U.S. Department of Health and Human Services

Safety

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Lovaza (omega-3-acid ethyl esters) capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009 and August 2012

 

August 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Recurrent Atrial Fibrillation (AF) or Flutter
  • In a double-blind, placebo-controlled trial of 663 patients with symptomatic paroxysmal AF (n=542) or persistent AF (n=121), recurrent AF or flutter was observed in patients randomized to Lovaza who received 8 grams/day for 7 days and 4 grams/day thereafter for 23 weeks at a higher rate relative to placebo…

 

September 2009 

Summary View

 

CLINICAL PHARMACOLOGY

Drug-Drug Interactions
  • Simvastatin: In a 14-day study of 24 healthy adult subjects, daily co-administration of simvastatin 80 mg with Lovaza 4 grams did not affect the extent  (AUC) or rate (Cmax) of exposure to simvastatin or the major active metabolite, beta-hydroxy simvastatin at steadhttp://wcms.fda.gov/ucm/resources/wcm/sitestudio/y state.
  • Atorvastatin: In a 14-day study of 50 healthy adult subjects, daily co-administration of atorvastatin 80 mg with Lovaza 4 grams did not affect AUC or Cmax of exposure to atorvastatin, 2-hydroxyatorvastatin, or 4-hydroxyatorvastatin at steady state.
  •  Rosuvastatin: In a 14-day study of 48 healthy adult subjects, daily co-administration of rosuvastatin 40 mg with Lovaza 4 grams did not affect AUC or Cmax of exposure to rosuvastatin at steady state.

 

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