FDA Approves Cialis to Treat Enlarged Prostate

Oct. 6, 2011 -- Cialis has been approved by the FDA for the treatment of enlarged prostate. It may also be used to treat men who have both enlarged prostate and erectile dysfunction (ED) at the same time.

Cialis is the first ED drug to be approved for treating benign prostatic hyperplasia (BPH). Commonly known as enlarged prostate, symptoms include difficulty starting to urinate, a weak urine stream, sudden urge to urinate, and frequent urination at night.

Eli Lilly's Cialis was approved as an ED treatment in 2003. The new approval is based on clinical trials showing that 5 milligrams of Cialis once a day improve BPH symptoms.

"BPH can have a big impact on a patient's quality of life," Scott Monroe, director of the FDA's division of reproductive and urologic products, says in a news release. "A large number of older men have symptoms of BPH. Cialis offers these men another treatment option, particularly those who also have ED, which is also common in older men."

Men taking nitrate-based drugs, such as nitroglycerin, should not take Cialis as it can lead to dangerous drops in blood pressure.

The FDA also warns men already taking alpha-blockers for BPH not to add Cialis to their treatment regimen. The two types of drug have not been tested together and theoretically could lead to a drop in blood pressure.

Alpha-blockers approved for the treatment of BPH include Cardura, Flomax, Hytrin, Rapaflo, and Uroxatral.

Also approved for BPH treatment are the male-hormone-inhibiting drugs Avodart, Jaylyn, and Proscar.