FDA OKs Impotence Drug Cialis to Treat Enlarged
THURSDAY, Oct. 6 (HealthDay News) -- The U.S. Food and Drug
Administration announced late Thursday that it had approved using
the erectile dysfunction drug Cialis as a treatment for enlarged
According to the U.S. National Institutes of Health, enlarged
prostate -- clinically known as benign prostatic hyperplasia (BPH)
-- is a "common part of aging" for men. In fact, the NIH estimates
that "more than half of men in their 60s, and as many as 90 percent
in their 70s and 80s, have some symptoms of BPH."
The condition often leads to urinary incontinence and can raise
the odds for urinary tract infections and even kidney damage.
"BPH 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. "A large number of older men have symptoms of BPH. Cialis [tadalifil] offers these men another treatment option, particularly those who also have ED, which is also common in older men," he said.
The FDA said its approval was made on the basis of three
studies. Two of the studies looked at changes in BPH symptom
severity based on the International Prostate Symptom Score. Those
trials found that men who took the 5-milligram dose of Cialis one
per day experienced an improvement in BPH symptoms vs. men who took
a dummy pill.
A third study, which involved men who suffered from both
impotence and enlarged prostate, found that the daily 5-milligram
dose of Cialis improved symptoms for both conditions.
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 can cause an unsafe decrease
in blood pressure." People taking heart medications known as alpha
blockers should also avoid Cialis because its use alongside these
drugs has not yet been studied and the combination might lower
Other drugs have already received FDA approval for the treatment
of BPH. These include Proscar, (finasteride), Avodart
(dutasteride), Jalyn (dutasteride plus tamsulosin), and the alpha
blockers Hytrin (terazosin), Cardura (doxazosin), Flomax
(tamsulosin), Uroxatral (alfuzosin) and Rapaflo (silodosin).
Find out more about BPH at the
U.S. National Institute of Diabetes and Digestive ...
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