ADVERSE REACTIONS The Phase 2 and 3 clinical trial program for DETROL LA Capsules included 1073 patients who were treated with DETROL LA (n= 537) or placebo (n= 536). The patients were treated with 2, 4, 6, or 8 mg/ day for up to 15 months. 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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. The data described below reflect exposure to DETROL LA 4 mg once daily every morning in 505 patients and to placebo in 507 patients exposed for 12 weeks in the Phase 3, controlled clinical study. Adverse events were reported in 52% (n= 263) of patients receiving DETROL LA and in 49% (n= 247) of patients receiving placebo. The most common adverse events reported by patients receiving DETROL LA were dry mouth, headache, constipation, abdominal pain. Dry mouth was the most frequently reported adverse event for patients treated with DETROL LA occurring in 23.4% of patients treated with DETROL LA and 7.7% of placebo-treated patients. Dry mouth, constipation, abnormal vision (accommodation abnormalities), urinary retention, and dry eyes are expected side effects of antimuscarinic agents. A serious adverse event was reported by 1.4% (n= 7) of patients receiving DETROL LA and by 3.6% (n= 18) of patients receiving placebo. | ||||
Email this article
Printer friendly
Bookmark this pageadvertisement
