The erectile dysfunction drug Cialis is now approved to treat symptoms of prostate gland enlargement, the Food and Drug Administration announced today.
Cialis, manufactured by Eli Lilly and Co., was approved for the treatment of erectile dysfunction (ED ) in 2003. It can now be used to treat ED and prostate gland enlargement, or both if symptoms of the two conditions occur together, the FDA said.
Benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, is common in older men. Symptoms include difficulty starting urination, a weak urine stream, a sudden urge to urinate and more frequent urination including at night.
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"BPH can have a big impact on a patient's quality of life," said Scott Monroe, director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research. "Cialis offers these men another treatment option, particularly those who also have ED, which is also common in older men."
In two clinical trials, men with BPH who took 5 milligrams of Cialis once daily experienced a significant improvement in their symptoms of BPH compared to men who were treated with placebo, the FDA said.
In a third study, men who experienced both ED and BPH and who took 5 mg of Cialis once daily had improvement in both their symptoms of BPH and in their ED compared to men who were treated with placebo, the agency said.
Cialis should not be used in patients taking nitrates, for example nitroglycerin, because the combination can cause an unsafe decrease in blood pressure, the FDA said. And the use of Cialis in combination with alpha blockers for the treatment of BPH is not recommended because the combination has not been adequately studied, and there is a risk of lowering blood pressure.
The FDA has approved eight other drugs to treat symptoms of BPH: Proscar, (finasteride), Avodart (dutasteride), Jalyn (dutasteride plus tamsulosin), and the alpha blockers: Hytrin (terazosin), Cardura (doxazosin), Flomax (tamsulosin), Uroxatral (alfuzosin) and Rapaflo (silodosin).
Pass it on: Cialis is now FDA approved to treat prostate enlargement.
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