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adverse reactions
ADVERSE REACTIONS During the clinical development of ENABLEX ® (darifenacin) extended-release tablets, a total of 7,363 patients and volunteers were treated with doses of darifenacin from 3.75 mg to 75 mg once daily. The safety of ENABLEX was evaluated in Phase II and III controlled clinical trials in a total of 8,830 patients, 6,001 of whom were treated with ENABLEX. Of this total, 1,069 patients participated in three, 12-week, Phase III, fixed-dose efficacy and safety studies. Of this total, 337 and 334 patients received ENABLEX 7.5 mg daily and 15 mg daily, respectively. In all long-term trials combined, 1,216 and 672 patients received treatment with ENABLEX for at least 24 and 52 weeks, respectively. In all placebo-controlled trials combined, the incidence of serious adverse events for 7.5 mg, 15 mg and placebo was similar. In all fixed-dose Phase III studies combined, 3.3% of patients treated with ENABLEX discontinued due to all adverse events versus 2.6% in placebo. Dry mouth leading to study discontinuation occurred in 0%, 0.9%, and 0% of patients treated with ENABLEX 7.5 mg daily, ENABLEX 15 mg daily and placebo, respectively. Constipation leading to study discontinuation occurred in 0.6%, 1.2%, and 0.3% of patients treated with ENABLEX 7.5 mg daily, ENABLEX 15 mg daily and placebo, respectively. Table 4 lists the adverse events reported (regardless of causality) in 2% or more of patients treated with 7.5-mg or 15-mg ENABLEX extended-release tablets and greater than placebo in the three, fixed-dose, placebo-controlled Phase III studies (Studies 1, 2 and 3). Adverse events were reported by 54% and 66% of patients receiving 7.5 mg and 15 mg once-daily ENABLEX extended-release tablets, respectively, and by 49% of patients receiving placebo. In these studies, the most frequently reported adverse events were dry mouth and constipation. The majority of adverse events in ENABLEX-treated subjects were mild or moderate in severity and most occurred during the first two weeks of treatment. Table 4: Incidence of Adverse Events* Reported in ≥2.0% of Patients Treated with ENABLEX ® Extended-Release Tablets and More Frequent with ENABLEX ® than with Placebo in Three, Fixed-Dose, Placebo-Controlled, Phase III Studies (Studies 1, 2, and 3) Body System Adverse Event Percentage of Subjects with Adverse Event (%) ENABLEX ® 7.5 mg N=337 ENABLEX ® 15 mg N=334 Placebo N=388 Digestive Dry Mouth Constipation Dyspepsia Abdominal Pain Nausea Diarrhea 20.2 14.8 2.7 2.4 2.7 2.1 35.3 21.3 8.4 3.9 1.5 0.9 8.2 6.2 2.6 0.5 1.5 1.8 Urogenital Urinary Tract Infection 4.7 4.5 2.6 Nervous Dizziness 0.9 2.1 1.3 Body as a Whole Asthenia 1.5 2.7 1.3 Eye Dry Eyes 1.5 2.1 0.5 *Regardless of causality Other adverse events reported, regardless of causality, by ≥1% of ENABLEX patients in either the 7.5 mg or 15 mg once-daily darifenacin-dose groups in these fixed-dose, placebo-controlled Phase III studies include: abnormal vision, accidental injury, back pain, dry skin, flu syndrome, pain, hypertension, vomiting, peripheral edema, weight gain, arthralgia, bronchitis, pharyngitis, rhinitis, sinusitis, rash, pruritus, urinary tract disorder and vaginitis. Study 4 was a 12-week, placebo-controlled, dose-titration regimen study in which ENABLEX was administered in accordance with dosing recommendations (see DOSAGE AND ADMINISTRATION). All patients initially received placebo or ENABLEX 7.5 mg daily, and after two weeks, patients and physicians were allowed to adjust upward to ENABLEX 15 mg if needed. In this study, the most commonly reported adverse events were also constipation and dry mouth. The incidence of discontinuation due to all adverse events was 3.1% and 6.7% for placebo and for ENABLEX, respectively. Table 5 lists the adverse events (regardless of causality) reported in >3% of patients treated with ENABLEX extended-release tablets and greater than placebo. Table 5: Number (%) of Adverse Events* Reported in >3% of Patients Treated with ENABLEX ® Extended-Release Tablets, and More Frequent with ENABLEX ® than Placebo, in the Placebo-Controlled, Dose-Titration, Phase III Study (Study 4) Adverse Event ENABLEX ® 7.5 mg/15 mg N=268 Placebo N=127 Constipation Dry Mouth Headache Dyspepsia Nausea Urinary Tract Infection Accidental Injury Flu Syndrome 56 (20.9%) 50 (18.7%) 18 (6.7%) 12 (4.5%) 11 (4.1%) 10 (3.7%) 8 (3.0%) 8 (3.0%) 10 (7.9%) 11 (8.7%) 7 (5.5%) 2 (1.6%) 2 (1.6%) 4 (3.1%) 3 (2.4%) 3 (2.4%) *Regardless of causality Acute urinary retention (AUR) requiring treatment was reported in a total of 16 patients in the ENABLEX Phase I-III clinical trials. Of these 16 cases, seven were reported as serious adverse events, including one patient with detrusor hyperreflexia secondary to a stroke, one patient with benign prostatic hypertrophy (BPH), one patient with irritable bowel syndrome (IBS) and four overactive bladder (OAB) patients taking darifenacin 30 mg daily. Of the remaining nine cases, none were reported as serious adverse events. Three occurred in OAB patients taking the recommended doses, and two of these required bladder catheterization for 1-2 days. Constipation was reported as a serious adverse event in six patients in the ENABLEX Phase I-III clinical trials, including one patient with benign prostatic hypertrophy (BPH), one OAB patient taking darifenacin 30 mg daily, and only one OAB patient taking the recommended doses. The latter patient was hospitalized for investigation with colonoscopy after reporting nine months of chronic constipation that was reported as being moderate in severity. Postmarketing Experience The following events have been reported in association with darifenacin use in worldwide postmarketing experience. Because these spontaneously reported events are from the worldwide postmarketing experience, the frequency of events and the role of darifenacin in their causation cannot be reliably determined. General: hypersensitivity reactions, including angioedema with airway obstruction. Central Nervous: confusion and hallucinations. Cardiovascular: palpitations