Tadalafil Approved for Benign Prostatic Hyperplasia

October 06, 2011

October 6, 2011 — The US Food and Drug Administration (FDA) today approved tadalafil (Cialis, Eli Lilly), a phosphodiesterase-5 inhibitor, to also treat the signs and symptoms of benign prostatic hyperplasia (BPH) as well as a combination of BPH and erectile dysfunction (ED) when the conditions coincide.

Men with BPH often experience sudden urges to urinate, difficulty in starting urination, a weak urine stream, and more frequent urination, including at night. In 2 clinical trials, men with BPH who took 5 mg of tadalafil daily experienced a significant improvement in these symptoms compared with men receiving a placebo. A third study showed that men who experienced both ED and BPH and who took 5 mg of tadalafil daily had improvement in both conditions compared with a placebo group.

Scott Monroe, MD, director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research, said in a press release that both BPH and ED are common disorders among older men. "Cialis offers these men another treatment option," Dr. Monroe said.

Tadalafil (Cialis)

Tadalafil joins a long list of other FDA-approved drugs for BPH symptoms: finasteride (Proscar), dutasteride (Avodart), dusasteride plus tamsulosin (Jalyn), and alpha-blockers terazosin (Hytrin), doxazosin (Cardura), tamsulosin (Flomax), alfuzosin (Uroxatral), and silodosin (Rapaflo).

The agency approved tadalafil for treating ED in 2003.

The FDA advises clinicians that they should not prescribe tadalafil for men taking nitrates such as nitroglycerin because the combination may trigger an unsafe drop in blood pressure. Also, the agency does not recommend combining tadalafil with alpha-blockers for the treatment of BPH because the combo therapy has not been adequately studied, and it comes with a risk of lowering blood pressure.

More information about today's FDA announcement is available on the agency's Web site.

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