The erectile dysfunction drug Cialis (tadalafil has received new approval from the US Food and Drug Administration (FDA) to treat benign prostatic hyperplasia (BPH), the medical term for an enlarged prostate.

Symptoms of BPH frequently include difficulty urinating, a sudden urge to urinate, and an increase in having to urinate, notably at night.

The drug was evaluated among men with BPH in three trials. Those who took 5 milligrams (mg) of Cialis once daily showed significant reduction in symptoms of BPH, the FDA said in a news release. The third trial involved men with BPH who also had been diagnosed with erectile dysfunction.

Men who take a class of drugs called nitrates, including nitroglycerin, shouldn't take Cialis in tandem, since the combination could lead to an unsafe drop in blood pressure, the FDA said. The agency made a similar warning about taking Cialis along with alpha-blocker drugs, which typically are prescribed to treat high blood pressure or as well as BPH.

Eight other drugs have been approved to treat symptoms of BPH: Proscar (finasteride), Avodart (dutasteride), Jalyn (dutasteride and tamsulosin), Hytrin (terazosin), Cardura (doxazosin), Flomax (tamsulosin), Uroxatral (alfuzosin) and Rapaflo (silodosin).

Cialis is produced by Indianapolis-based Eli Lilly and Co.

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