Yan Etkiler / Advers Reaksiyonlar

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 trial of another drug and may not reflect the rates observed in practice. The most common adverse reactions (incidence > 5% and > placebo) were dry mouth and application site reactions. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Watson Pharmaceuticals, Inc. at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience The safety of GELNIQUE was evaluated in 789 patients (389 randomized to GELNIQUE 1 g and 400 randomized to placebo) during a randomized, placebo-controlled, double-blind, 12-week clinical efficacy and safety study. A subset of these 789 patients (N=216) participated in the 14-week open-label safety extension that followed the placebo-controlled study. Of 216 patients in the safety extension, 107 were randomized to placebo gel during the double-blind, placebo-controlled 12-week study. In the combined double-blind, placebo-controlled study and the open-label safety extension, a total of 496 patients were exposed to at least one dose of GELNIQUE. Four hundred thirty-one (431) patients received at least 12 weeks of GELNIQUE treatment and 85 patients received 26 weeks of GELNIQUE treatment. The study population primarily consisted of Caucasian women (approximately 90%) with an average age of 59 years who had overactive bladder with urge urinary incontinence. Table 1 lists adverse events, regardless of causality, that were reported in the randomized, double-blind, placebo-controlled 12-week study at an incidence greater than placebo and in greater than 2% of patients treated with GELNIQUE. Table 1: Common Adverse Events in the Randomized, Double-blind, Placebo-controlled 12-Week Study (>2% and > placebo) Adverse Event GELNIQUE 1 gram N=389 n (%) Placebo N=400 n (%) * Includes application site pruritus, dermatitis, papules, anesthesia, erythema, irritation, pain and papules Dry mouth 29 (7.5) 11 (2.8) Urinary tract infection 27 (6.9) 17 (4.3) Application site reactions* 21 (5.4) 4 (1.0) Upper respiratory tract infection 21 (5.4) 20 (5.0) Dizziness 11 (2.8) 4 (1.0) Nasopharyngitis 11 (2.8) 9 (2.3) Fatigue 8 (2.1) 4 (1.0) Gastroenteritis viral 8 (2.1) 7 (1.8) The most common adverse reactions, defined as adverse events judged by the investigator to be reasonably associated with the use of study drug, that were reported in ? 1% of GELNIQUE-treated patients were dry mouth (6.9%), application site reactions (5.4%), dizziness (1.5%), headache (1.5%), constipation (1.3%), and pruritus (1.3%). Application site pruritus (2.1%) and application site dermatitis (1.8%) were the most commonly reported application site reactions. A majority of treatment-related adverse events were described as mild or moderate in intensity, except for two patients reporting severe headache. No serious adverse events were judged by the investigator to be treatment-related during the randomized, double-blind, placebo-controlled 12-week study. The most common adverse reaction leading to drug discontinuation was application site reaction (0.8% with GELNIQUE versus 0.3% with placebo). The most common adverse reactions reported during the 14-week open-label extension study were application site reactions (6.0%) and dry mouth (1.9%). The most common reason for premature discontinuation was application site reactions (9 patients or 4.2%). Two of these 9 patients experienced application site reactions of severe intensity (dermatitis, urticaria, and erythema).