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adverse reactions
6 ADVERSE REACTIONS Use of PATANASE Nasal Spray has been associated with epistaxis, nasal ulcerations, and somnolence [see Warnings and Precautions (5.1 and 5.2 )]. The most common (>1%) adverse reactions included bitter taste, headache, epistaxis, pharyngolaryngeal pain, post-nasal drip, cough, and urinary tract infection in patients 12 years of age and older and epistaxis, headache, upper respiratory tract infection, bitter taste, pyrexia, and rash in patients 6 to 11 years of age (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience The safety data described below reflect exposure to PATANASE Nasal Spray in 2,427 patients with seasonal or perennial allergic rhinitis in 9 controlled clinical trials of 2 weeks to 12 months duration. The safety data from adults and adolescents are based upon 5 placebo (vehicle nasal spray)-controlled clinical trials in which 1,491 patients with seasonal or perennial allergic rhinitis (513 males and 978 females) 12 years of age and older were treated with PATANASE Nasal Spray two sprays per nostril twice daily. There were 1,180 patients (PATANASE Nasal Spray, 587; vehicle nasal spray, 593) that participated in 3 efficacy and safety trials of 2 weeks duration. There were 1,814 patients (PATANASE Nasal Spray, 904; vehicle nasal spray, 910) that participated in 2 long-term clinical trials of 1 year duration. The racial distribution of adult and adolescent patients receiving PATANASE Nasal Spray was 76% white, 8% black, 12% Hispanic and 3% other. The incidence of discontinuation due to adverse reactions in these controlled clinical trials was comparable for PATANASE Nasal Spray and vehicle nasal spray. Overall, 3.9% of the 1,491 adult and adolescent patients across all 5 studies treated with PATANASE Nasal Spray and 3.2% of the 1,503 patients treated with vehicle nasal spray discontinued due to adverse reactions. The safety data from pediatric patients 6-11 years of age are based upon 3 clinical trials in which 870 children with seasonal allergic rhinitis (376 females and 494 males) were treated with PATANASE Nasal Spray 1 or 2 sprays per nostril twice daily for 2 weeks. The racial distribution of pediatric patients receiving PATANASE Nasal Spray was 68.6% white, 16.6% black, and 14.8% other. The incidence of discontinuation due to adverse reactions in these controlled clinical trials was comparable for PATANASE Nasal Spray and vehicle nasal spray. Overall, 1.4% of the 870 pediatric patients across all 3 studies treated with PATANASE Nasal Spray and 1.3% of the 872 pediatric patients treated with vehicle nasal spray discontinued due to adverse reactions. Safety information for pediatric patients 2 to 5 years of age is obtained from one vehicle-controlled study of 2 weeks duration [See Pediatric Use (8.4) ]. 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. Adults and Adolescents 12 Years of Age and Older in Short-Term (2-week) Trials : There were 1,180 patients 12 years of age and older (PATANASE Nasal Spray, 587; vehicle nasal spray, 593) that participated in 3 efficacy and safety trials of 2 weeks duration. Table 1 presents the most common adverse reactions (0.9% or greater in patients treated with PATANASE Nasal Spray) that occurred more frequently in patients treated with PATANASE Nasal Spray compared with vehicle nasal spray in the 3 clinical trials of 2 weeks duration. Table 1: Adverse Reactions Occurring at an Incidence of 0.9% or Greater in Controlled Clinical Trials of 2 Weeks Duration with PATANASE Nasal Spray in Adolescent and Adult Patients 12 Years of Age and Older with Seasonal Allergic Rhinitis Adult and Adolescent Patients 12 Years and Older Adverse Reaction PATANASE Nasal Spray N = 587 Vehicle Nasal Spray N = 593 Bitter taste 75 (12.8%) 5 (0.8%) Headache 26 (4.4%) 24 (4.0%) Epistaxis 19 (3.2%) 10 (1.7%) Pharyngolaryngeal Pain 13 (2.2%) 8 (1.3%) Post-nasal drip 9 (1.5%) 5 (0.8%) Cough 8 (1.4%) 3 (0.5%) Urinary tract infection 7 (1.2%) 3 (0.5%) CPK elevation 5 (0.9%) 2 (0.3%) Dry mouth 5 (0.9%) 1 (0.2%) Fatigue 5 (0.9%) 4 (0.7%) Influenza 5 (0.9%) 1 (0.2%) Nasopharyngitis 5 (0.9%) 4 (0.7%) Somnolence 5 (0.9%) 2 (0.3%) Throat irritation 5 (0.9%) 0 (0.0%) There were no differences in the incidence of adverse reactions based on gender or race. Clinical trials did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger subjects. Pediatric Patients 6 to 11 Years of Age : There were 1,742 pediatric patients 6 to 11 years of age (Olopatadine nasal spray, 870; vehicle nasal spray, 872) with seasonal allergic rhinitis that participated in 3 clinical trials of 2 weeks duration. Two of the studies used the investigational formulation of olopatadine nasal spray, and one of the studies used PATANASE Nasal Spray. One study evaluated the safety of PATANASE Nasal Spray at doses of 1 and 2 sprays per nostril twice daily in 1188 patients, in which 298 were exposed to PATANASE 1 spray, 296 were exposed to PATANASE 2 sprays, 297 were exposed to vehicle 1 spray, and 297 were exposed to vehicle 2 sprays twice daily for 2 weeks. Table 2 presents the most common adverse reactions (greater than 1.0% in pediatric patients 6-11 years of age treated with PATANASE Nasal Spray 1 spray/nostril) that occurred more frequently with PATANASE Nasal Spray compared with vehicle nasal spray. Table 2. Adverse Reactions Occurring at an Incidence of Greater than 1.0% in a Controlled Clinical Trial of 2 Weeks Duration with PATANASE Nasal Spray in Pediatric Patients 6-11 Years of Age With Seasonal Allergic Rhinitis Pediatric Patients 6 to 11 Years of Age Adverse Reaction PATANASE Nasal Spray 1 spray per nostril N = 298 Vehicle Nasal Spray 1 spray per nostril N = 297 Epistaxis Headache Upper respiratory tract infection Bitter taste 17 (5.7%) 13 (4.4%) 8 (2.6%) 3 (1.0%) 11 (3.7%) 11 (3.7%) 0 0 Pyrexia 4 (1.3%) 3 (1.0%) Rash 4 (1.3%) 0 There were no differences in the incidence of adverse reactions based on gender, race, or ethnicity. The safety of PATANASE Nasal Spray at a dose of 1 spray per nostril twice daily was evaluated in one 2- week vehicle-controlled study in 132 patients (PATANASE Nasal Spray, 66; vehicle nasal spray. 66) 2 to 5 years of age with allergic rhinitis [see Pediatric Use (8.4) ]. Long-Term (12-month) Safety Trials : In a 12-month, placebo (vehicle nasal spray)-controlled, safety trial, 890 patients 12 years of age and older with perennial allergic rhinitis were randomized to treatment with PATANASE Nasal Spray 2 sprays per nostril twice daily (445 patients) or vehicle nasal spray (445 patients). In the PATANASE and vehicle nasal spray groups, 72% and 74% of patients, respectively, completed the trial. Overall, 7% and 5%, respectively, discontinued study participation due to an adverse event. The most frequently reported adverse reaction was epistaxis, which occurred in 25% of patients treated with PATANASE Nasal Spray and 28% in patients treated with vehicle nasal spray. Epistaxis resulted in discontinuation of 0.9% of patients treated with PATANASE Nasal Spray and 0.2% of patients treated with vehicle nasal spray. Nasal ulcerations occurred in 10% of patients treated with PATANASE Nasal Spray and 9% of patients treated with vehicle nasal spray. Nasal ulcerations resulted in discontinuation of 0.4% of patients treated with PATANASE Nasal Spray and 0.2% patients treated with vehicle nasal spray. There were no patients with nasal septal perforation in either treatment group. Somnolence was reported in 1 patient treated with PATANASE Nasal Spray and 1 patient treated with vehicle nasal spray. Weight increase was reported in 6 patients treated with PATANASE Nasal Spray and 1 patient treated with vehicle nasal spray. Depression or worsening of depression occurred in 9 patients treated with PATANASE Nasal Spray and in 5 patients treated with vehicle nasal spray. Three patients, two of whom had pre-existing histories of depression, who received PATANASE Nasal Spray were hospitalized for depression compared to none who received vehicle nasal spray. In a second 12-month, placebo (vehicle nasal spray)-controlled, safety trial, 459 patients 12 years of age and older with perennial allergic rhinitis were treated with 2 sprays per nostril of an investigational formulation of PATANASE Nasal Spray containing povidone (not the commercially marketed formulation) and 465 patients were treated with 2 sprays of a vehicle nasal spray containing povidone. Nasal septal perforations were reported in one patient treated with the investigational formulation of PATANASE Nasal Spray and 2 patients treated with the vehicle nasal spray. Epistaxis was reported in 19% of patients treated with the investigational formulation of PATANASE Nasal Spray and 12% of patients treated with vehicle nasal spray. Somnolence was reported in 3 patients treated with the investigational formulation of PATANASE Nasal Spray compared to 1 patient treated with vehicle nasal spray. Fatigue was reported in 5 patients treated with the investigational formulation of PATANASE Nasal Spray compared to 1 patient treated with vehicle nasal spray. There were no long-term clinical trials in children below 12 years of age. 6.2 Post-Marketing Experience The post-marketing adverse events reported post-approval are consistent with the adverse events reported during clinical trials. Because post-marketing adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.