A selection of LOVAZA® safety information for your patients. Full important safety information can be found here.
LOVAZA® is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to LOVAZA® or any of its components (4).
Anticoagulants or Other Drugs Affecting Coagulation
Some trials with omega-3-acids demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in these trials has not exceeded normal limits and did not produce clinically significant bleeding episodes. Clinical trials have not been done to thoroughly examine the effect of LOVAZA® and concomitant anticoagulants. Patients receiving treatment with LOVAZA® and an anticoagulant or other drug affecting coagulation (e.g., anti-platelet agents) should be monitored periodically (7.1).
LOVAZA® contains ethyl-esters of omega-3 fatty acids (EPA and DHA) obtained from the oil of several fish sources. It is not known whether patients with allergies to fish and/or shellfish, are at increased risk of an allergic reaction to LOVAZA®. LOVAZA® should be used with caution in patients with known hypersensitivity to fish and/or shellfish (5).
Recurrent Atrial Fibrillation (AF) or Flutter
In a double-blind, placebo-controlled trial of 663 subjects with symptomatic paroxysmal AF (n = 542) or persistent AF (n = 121), recurrent AF or flutter was observed in subjects 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. Subjects in this trial had median baseline TG levels of 127 mg/dL, had no substantial structural heart disease, were taking no anti-arrhythmic therapy (rate control permitted), and were in normal sinus rhythm at baseline (5.3).
At 24 weeks, in the paroxysmal AF stratum, there were 129 (47%) first recurrent symptomatic AF or flutter events on placebo and 141 (53%) on LOVAZA® (primary endpoint, HR: 1.19; 95% CI: 0.93, 1.35). In the persistent AF stratum, there were 19 (35%) events on placebo and 34 (52%) events on LOVAZA® (HR: 1.63; 95% CI: 0.91, 2.18). For both strata combined, the HR was 1.25; 95% CI: 1, 1.4. Although the clinical significance of these results is uncertain, there is a possible association between LOVAZA® and more frequent recurrences of symptomatic AF or flutter in patients with paroxysmal or persistent AF, particularly within the first 2 to 3 months of initiating therapy (5.3).
LOVAZA® is not indicated for the treatment of AF or flutter (5.3).
In clinical trials, the most common reported adverse reactions to LOVAZA® were eructation, dyspepsia, and taste perversion (6.1).