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FDA Safety Label Changes for Lovaza (Omega-3-Acid Ethyl Esters)
FORUM FOR PSYCHIATRY RESIDENTS :: Psychiatry :: Psychiatry-Neurology-Psychology discussion :: Psychiatry In Depth
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FDA Safety Label Changes for Lovaza (Omega-3-Acid Ethyl Esters)
Admin 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
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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