On October 6, 2011, the US Food and Drug Administration (FDA) approved tadalafil (Cialis®; Eli Lilly and Company; Indianapolis, Indiana) for benign prostatic hyperplasia (BPH) and erectile dysfunction with signs and symptoms of BPH. The approval is based on clinical trials which found statistically significant improvement in symptoms of BPH in men taking this phosphodiesterase-5 inhibitor compared with men taking placebo. Tadalafil should not be used in men taking nitrates, and use in combination with alpha-blockers for BPH is not recommended due to lack of studies and risk of lowering blood pressure.
For more information, see Tadalafil Approved for Benign Prostatic Hyperplasia.
