Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions reported by at least 3% of EPANOVA-treated individuals and with a higher incidence than placebo (olive oil), based on pooled data from two clinical trials of 6-and 12week duration involving subjects with hypertriglyceridemia, are listed in Table 1.
Table 1: Adverse Reactions Occurring at Incidence ≥ 3%
and Greater than Placebo in Placebo-Controlled Trials*
|Abdominal pain or discomfort||2%||3%||5%|
|* Trials included subjects with hypertriglyceridemia of varying severity.|
In a pool of two longer-term ( ≥ 52 weeks) placebo-controlled clinical trials involving 748 patients (376 EPANOVA 4 grams per day; 372 placebo) with chronic gastrointestinal disease, additional common adverse reactions reported more often by EPANOVA-treated patients included abdominal distension, constipation, vomiting, fatigue, nasopharyngitis, arthralgia, and dysguesia.
Read the Epanova (omega-3-carboxylic acids soft-gelatin capsules) Side Effects Center for a complete guide to possible side effects
Anticoagulants Or Other Drugs Affecting Coagulation
Patients taking anti-platelet agents or anticoagulants were excluded from EPANOVA clinical trials involving patients with hypertriglyeridemia. Some published studies with omega-3 fatty acids have demonstrated prolongation of bleeding time. The prolongation of bleeding time reported in those studies has not exceeded normal limits and did not produce clinically significant bleeding episodes. Nonetheless, patients receiving treatment with EPANOVA and drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
Last reviewed on RxList: 5/20/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Epanova Information
Report Problems to the Food and Drug Administration
Tips to keep it under control.