FDA Approves Cialis (Tadalafil) for Treating Enlarged Prostate Symptoms

Cialis (tadalafil), a popular drug for erectile dysfunction (ED), has been approved by the Food and Drug Administration (FDA) for the treatment of enlarged prostate symptoms. It may also be used to treat men who have both erectile dysfunction and enlarged prostate at the same time.

Cialis is the first ED drug to be approved for treating enlarged prostate and becomes the ninth approved by FDA to help men with BPH.

Enlarged prostate, clinically known as benign prostatic hyperplasia (BPH), is the most common problem for elderly men. This condition often leads to urinary incontinence, which is the uncontrollable leakage of urine.

“Enlarged prostate can have a big impact on a patient’s quality of life,” Scott Monroe, director of the division of reproductive and urologic products in the FDA’s Center for Drug Evaluation and Research, said in an agency news release.

“Many older men have symptoms of enlarged prostate and Cialis may help treat this problem, particularly on those who also have erectile dysfunction,” he added.

The FDA said that the approval was made on the basis of three studies. In two clinical studies that looked at changes in BPH symptom severity based on the International Prostate Symptom Score. They found that men who took 5 mg of Cialis per day experienced an improvement in BPH symptoms compared to those who took a dummy pill.

A third study, which involved men who suffered from both impotence and enlarged prostate, found that the daily 5 mg dose of Cialis improved symptoms for both conditions.

However, not all patients can use this drug. The FDA warned that Cialis, which is made by Eli Lilly and Co., should not be used in patients taking nitrates, for example nitroglycerin, because the combination of the two drugs can cause an unsafe decrease in blood pressure.

In addition, people who taking heart medications known as alpha blockers should also avoid Cialis because the two types of drug have not been tested together and the combination might lead to a drop in blood pressure.

Other drugs that have been approved by FDA for the treatment of enlarged prostate include Proscar (finasteride), Avodart (dutasteride), Jalyn (dutasteride plus tamsulosin), and the alpha blockers Hytrin (terazosin), Cardura (doxazosin), Flomax (tamsulosin), Uroxatral (alfuzosin) and Rapaflo (silodosin).

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