Objective
A large-scale, multicenter, double-blind study (US 92-03A) was performed in which the side effects of tamsulosin treatment were investigated.1 (Learn more about the design of US 92-03A.) A second double-blind, phase III, placebo controlled, multicenter trial with an identical protocol (US 93-01) was undertaken to study the safety and efficacy of tamsulosin for the treatment of patients with signs and symptoms of BPH. (Learn more about the design of US 93-01.)
Results
Adverse events that occurred in ≥2% of tamsulosin patients receiving 0.4 mg/day or placebo at an incidence numerically higher than that in the placebo group during the two 13-week trials are summarized in the table below.2,3
Discontinuation rates due to tamsulosin treatment (0.4 mg/day) were comparable to those of placebo, and no patients stopped therapy because of abnormal ejaculation.2
Notably, there were low rates of syncope and symptomatic postural hypotension. Patients receiving tamsulosin therapy demonstrated low discontinuation rates.3
Important Safety Information
FLOMAX is indicated to treat the signs and symptoms of benign prostatic hyperplasia (BPH). FLOMAX is not indicated to treat hypertension. As with other alpha-adrenergic blocking agents, there is a potential risk of syncope. Patients beginning treatment with FLOMAX should be cautioned to avoid driving or hazardous tasks for 12 hours after their first dose or increase in dose should syncope occur. The most common side effects are dizziness, abnormal ejaculation, and rhinitis.
Caution should be exercised with concomitant administration of warfarin and FLOMAX. In addition, FLOMAX should be used with caution in combination with cimetidine, particularly at doses higher than 0.4 mg. FLOMAX is contraindicated in patients known to be hypersensitive to tamsulosin HCl or any component of FLOMAX.
Before prescribing FLOMAX, please see the full Prescribing Information.
1. Lepor H for the Tamsulosin Investigator Group. Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Urology. 1998;51:892-900.
2. FLOMAX Prescribing Information, Boehringer Ingelheim Pharmaceuticals, Inc.
3. Data on file, Boehringer Ingelheim Pharmaceuticals, Inc.
