Vascepa Adverse Reactions

Adverse Drug Reaction Overview: The safety of VASCEPA was evaluated in 8,179 patients in the REDUCE-IT cardiovascular outcomes trial, with 4,089 receiving VASCEPA and 4,090 patients receiving placebo. The median duration was 4.9 years. The overall adverse event rates were similar in patients treated with VASCEPA (82%), compared to placebo (81%), while the incidence of serious adverse events was the same in patients treated with VASCEPA (31%) and placebo (31%). The rate of adverse events leading to discontinuation of study drug was also the same in patients treated with VASCEPA (8%) and placebo (8%). The most common adverse reaction with VASCEPA reported in ≥5% of patients and significantly greater than placebo was peripheral edema.
Clinical Trial Adverse Drug Reactions: Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.
Adverse Reactions in the REDUCE-IT trial: In this double-blind, randomized, placebo-controlled cardiovascular outcomes trial, 4,089 patients were randomized to VASCEPA, and 4,090 to placebo (see Pharmacology: Clinical Trials: Prevention of Cardiovascular Events under Actions). The median age of enrolled patients was 64 years (range: 44 to 92 years), and 46% were 65 years of age or older. Twenty-nine percent (29%) were female, 90.2% were White, 5.5% were Asian, and 4.2% identified as Hispanic ethnicity, and 1.9% were Black. Patients were exposed to VASCEPA or placebo for a median of 4.3 years; with 87% of patients for ≥12 months, 77% for ≥24 months, 65% for ≥36 months, 54% for ≥48 months, 29% for ≥60 months. (See Table 2.)

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Cardiovascular: Atrial Fibrillation: In the REDUCE-IT trial, adjudicated events of atrial fibrillation/atrial flutter were observed more frequently in the VASCEPA group than in the placebo group, at 3.1% and 2.1%, respectively (p=0.004). The incidence of unadjudicated atrial fibrillation/atrial flutter adverse events was also significantly higher in the VASCEPA group than in the placebo group, at 5.8% and 4.5% of patients, respectively (p=0.008).
Hematologic: Bleeding: In the REDUCE-IT trial, a significantly higher incidence of bleeding events was observed with VASCEPA than with placebo, at 11.8% and 9.9% of patients, respectively (p=0.006). Serious adverse bleeding events were observed in 2.7% of patients exposed to VASCEPA, and 2.1% to placebo, (p=0.06). There were no significant differences between the VASCEPA-treated group and the placebo group in the rates of adjudicated hemorrhagic stroke, at 0.3% and 0.2% (p=0.54), or serious gastrointestinal bleeding, at 1.5% and 1.1%, respectively (p=0.15).
Less Common Clinical Trial Adverse Reactions: The following less common adverse reactions at <5% in the VASCEPA group and at least 1% greater than in the placebo group are presented as follows.
Metabolism and nutrition disorders: gout.
Musculoskeletal and connective tissue disorders: musculoskeletal pain.
Post-Market Adverse Reactions: The following adverse reactions have been identified from global post-marketing use of VASCEPA. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish causal relationship to drug exposure: arthralgia, diarrhea, abdominal discomfort, and pain in the extremities.