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FDA Safety Label Changes for Lovaza (Omega-3-Acid Ethyl Esters)

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FDA Safety Label Changes for Lovaza (Omega-3-Acid Ethyl Esters)

Post  Admin on Thu Oct 18, 2012 9:51 pm


Lovaza (Omega-3-Acid Ethyl Esters) Capsules
Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research


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.

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.

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