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adverse reactions
ADVERSE REACTIONS Table 1 summarizes adverse events from 22 repeat-dose studies in patients with IBS who were treated with 1 mg of LOTRONEX twice daily for 8 to 24 weeks. The adverse events in Table 1 were reported in 1% or more of patients who received LOTRONEX and occurred more frequently on LOTRONEX than on placebo. A statistically significant difference was observed for constipation in patients treated with LOTRONEX compared to placebo (p<0.0001). Table 1. Adverse Events Reported in ≥1% of IBS Patients and More Frequently on LOTRONEX 1 mg B.I.D. Than Placebo Body System Adverse Event LOTRONEX 1 mg B.I.D. (n = 8,328) Placebo (n = 2,363) Gastrointestinal Constipation 29% 6% Abdominal discomfort and pain 7% 4% Nausea 6% 5% Gastrointestinal discomfort and pain 5% 3% Abdominal distention 2% 1% Regurgitation and reflux 2% 2% Hemorrhoids 2% 1% Gastrointestinal Constipation is a frequent and dose-related side effect of treatment with LOTRONEX (see WARNINGS). In clinical studies constipation was reported in approximately 29% of IBS patients treated with LOTRONEX 1 mg twice daily (n = 9,316). This effect was statistically significant compared to placebo (p<0.0001). Eleven percent (11%) of patients treated with LOTRONEX 1 mg twice daily withdrew from the studies due to constipation. Although the number of IBS patients treated with LOTRONEX 0.5 mg twice daily is relatively small (n = 243), only 11% of those patients reported constipation and 4% withdrew from clinical studies due to constipation. Among the patients treated with LOTRONEX 1 mg twice daily who reported constipation, 75% reported a single episode and most reports of constipation (70%) occurred during the first month of treatment with the median time to first report of constipation onset of 8 days. Occurrences of constipation in clinical trials were generally mild to moderate in intensity, transient in nature, and resolved either spontaneously with continued treatment or with an interruption of treatment. However, serious complications of constipation have been reported in clinical studies and in postmarketing experience (see BOXED WARNING and WARNINGS). In Studies 1 and 2, 9% of patients treated with LOTRONEX reported constipation and 4 consecutive days with no bowel movement (see CLINICAL TRIALS). Following interruption of treatment, 78% of the affected patients resumed bowel movements within a 2-day period and were able to re-initiate treatment with LOTRONEX. Hepatic A similar incidence in elevation of ALT (>2–fold) was seen in patients receiving LOTRONEX or placebo (1.0% vs. 1.2%). A single case of hepatitis (elevated ALT, AST, alkaline phosphatase, and bilirubin) without jaundice was reported in a 12-week study. A causal association with LOTRONEX has not been established. Long-Term Safety Patient experience in controlled clinical trials is insufficient to estimate the incidence of ischemic colitis in patients taking LOTRONEX for longer than 6 months. Other Events Observed During Clinical Evaluation of LOTRONEX During its assessment in clinical trials, multiple and single doses of LOTRONEX were administered resulting in 11,874 subject-exposures in 86 completed clinical studies. The conditions, dosages, and duration of exposure to LOTRONEX varied between trials, and the studies included healthy male and female volunteers as well as male and female patients with IBS and other indications. In the listing that follows, reported adverse events were classified using a standardized coding dictionary. Only those events that an investigator believed were possibly related to alosetron, occurred in at least 2 patients, and occurred at a greater frequency during treatment with LOTRONEX than during placebo administration are presented. Serious adverse events occurring in at least 1 patient for whom an investigator believed there was reasonable possibility that the event was related to alosetron treatment and occurring at a greater frequency in LOTRONEX than placebo-treated patients are also presented. In the following listing, events are categorized by body system. Within each body system, events are presented in descending order of frequency. The following definitions are used: Infrequent adverse events are those occurring on one or more occasion in 1/100 to 1/1,000 patients; Rare adverse events are those occurring on one or more occasion in fewer than 1/1,000 patients. Although the events reported occurred during treatment with LOTRONEX, they were not necessarily caused by it. Blood and Lymphatic Rare Quantitative red cell or hemoglobin defects, hemorrhage, and lymphatic signs and symptoms. Cardiovascular Infrequent Tachyarrhythmias. Rare Arrhythmias, increased blood pressure, and extrasystoles. Drug Interaction, Overdose, and Trauma Rare Contusions and hematomas. Ear, Nose, and Throat Rare Ear, nose, and throat infections; viral ear, nose, and throat infections; and laryngitis. Endocrine and Metabolic Rare Disorders of calcium and phosphate metabolism, hyperglycemia, hypothalamus/pituitary hypofunction, hypoglycemia, and fluid disturbances. Eye Rare Light sensitivity of eyes. Gastrointestinal Infrequent Hyposalivation, dyspeptic symptoms, gastrointestinal spasms, ischemic colitis (see WARNINGS), and gastrointestinal lesions. Rare Abnormal tenderness, colitis, gastrointestinal signs and symptoms, proctitis, diverticulitis, positive fecal occult blood, hyperacidity, decreased gastrointestinal motility and ileus, gastrointestinal obstructions, oral symptoms, gastrointestinal intussusception, gastritis, gastroduodenitis, gastroenteritis, and ulcerative colitis. Hepatobiliary Tract and Pancreas Rare Abnormal bilirubin levels and cholecystitis. Lower Respiratory Infrequent Breathing disorders. Rare Viral respiratory infections. Musculoskeletal Rare Muscle pain; muscle stiffness, tightness and rigidity; and bone and skeletal pain. Neurological Infrequent Hypnagogic effects. Rare Memory effects, tremors, dreams, cognitive function disorders, disturbances of sense of taste, disorders of equilibrium, confusion, sedation, and hypoesthesia. Non-Site Specific Infrequent Malaise and fatigue, cramps, pain, temperature regulation disturbances. Rare General signs and symptoms, non-specific conditions, burning sensations, hot and cold sensations, cold sensations, and fungal infections. Psychiatry Infrequent Anxiety. Rare Depressive moods. Reproduction Rare Sexual function disorders, female reproductive tract bleeding and hemorrhage, reproductive infections, and fungal reproductive infections. Skin Infrequent Sweating and urticaria. Rare Hair loss and alopecia; acne and folliculitis; disorders of sweat and sebum; allergic skin reaction; eczema; skin infections; dermatitis and dermatosis; and nail disorders. Urology Infrequent Urinary frequency. Rare Bladder inflammation; polyuria and diuresis; and urinary tract hemorrhage. Postmarketing Experience The following events have been identified during use of LOTRONEX in clinical practice. Because they were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to LOTRONEX. Gastrointestinal Constipation, ileus, impaction, obstruction, perforation, ulceration, ischemic colitis, small bowel mesenteric ischemia (see WARNINGS). Neurological Headache. Skin Rash.