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adverse reactions
6 ADVERSE REACTIONS The most common adverse events (incidence >3% and greater than placebo) were eructation, infection, flu syndrome, and dyspepsia. (6) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 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 events reported in at least 1% of patients treated with LOVAZA 4 grams per day or placebo during 8 randomized, placebo-controlled, double-blind, parallel-group studies for HTG are listed in Table 1. Adverse events led to discontinuation of treatment in 3.5% of patients treated with LOVAZA and 2.6% of patients treated with placebo. Table 1. Adverse Events in Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Studies for Very High TG Levels (≥500 mg/dL) that used LOVAZA BODY SYSTEM Adverse Event * LOVAZA 4 grams/day (N = 226) Placebo (N = 228) n % n % Subjects with at least 1 adverse event 80 35.4 63 27.6 Body as a whole Infection 10 4.4 5 2.2 Flu syndrome 8 3.5 3 1.3 Back pain 5 2.2 3 1.3 Pain 4 1.8 3 1.3 Cardiovascular Angina pectoris 3 1.3 2 0.9 Digestive Eructation 11 4.9 5 2.2 Dyspepsia 7 3.1 6 2.6 Skin Rash 4 1.8 1 0.4 Special senses Taste perversion 6 2.7 0 0.0 * Adverse events were coded using COSTART, version 5.0. Subjects were counted only once for each body system and for each preferred term. Additional adverse events reported by 1 or more patients from clinical studies for HTG are listed below: Body as a Whole: Enlarged abdomen, asthenia, body odor, chest pain, chills, suicide, fever, generalized edema, fungal infection, malaise, neck pain, neoplasm, rheumatoid arthritis, and sudden death. Cardiovascular System: Arrhythmia, bypass surgery, cardiac arrest, hyperlipemia, hypertension, migraine, myocardial infarct, myocardial ischemia, occlusion, peripheral vascular disorder, syncope, and tachycardia. Digestive System: Anorexia, constipation, dry mouth, dysphagia, colitis, fecal incontinence, gastritis, gastroenteritis, gastrointestinal disorder, increased appetite, intestinal obstruction, melena, pancreatitis, tenesmus, and vomiting. Hematologic-Lymphatic System: Lymphadenopathy. Infections and Infestations: Viral infection. Metabolic and Nutritional Disorders: Edema, hyperglycemia, increased ALT, and increased AST. Musculoskeletal System: Arthralgia, arthritis, myalgia, pathological fracture, and tendon disorder. Nervous System: Central nervous system neoplasia, depression, dizziness, emotional lability, facial paralysis, insomnia, vasodilatation, and vertigo. Respiratory System: Asthma, bronchitis, increased cough, dyspnea, epistaxis, laryngitis, pharyngitis, pneumonia, rhinitis, and sinusitis. Skin: Alopecia, eczema, pruritus, and sweating. Special Senses: Cataract. Urogenital System: Cervix disorder, endometrial carcinoma, epididymitis, and impotence. 6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the events described below have been identified during post-approval use of LOVAZA. Because these events are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or to always establish a causal relationship to drug exposure. The following events have been reported: anaphylactic reaction, hemorrhagic diathesis.