Label Changes for:

Lovaza (omega 3-acid ethyl esters) Capsules

September 2012

Changes have been made to the WARNINGS, PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.

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

 

September 2012

5 WARNINGS AND PRECAUTIONS

5.3 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. ......
  • ..........Although the clinical significance of these results is uncertain, there is a possible association between LOVAZA and more frequent recurrences of symptomatic atrial fibrillation or flutter in patients with paroxysmal or persistent atrial fibrillation, particularly within the first 2 to 3 months of initiating therapy. LOVAZA is not indicated for the treatment of AF or flutter.

Patient Information Leaflet

What are the possible side effects of LOVAZA?

LOVAZA may cause serious side effects, including:

  • increases in the frequency of a heart rhythm problem (atrial fibrillation or flutter) may especially happen in the first few months of taking LOVAZA if you already have that problem

 

 

August 2012

 

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‚Ķ

 

September 2009 

 

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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