With its latest FDA approval, Cialis (tadalafil) can now help men shrink a certain swollen organ while also making another organ swell. The FDA has approved the erectile dysfunction medication to treat benign prostatic hyperplasia (BPH), also known as enlarged prostate.
Cialis was approved in 2003 to treat erectile dysfunction (ED). The drug now can also be used with the FDA's blessing to treat BPH and ED when the conditions occur simultaneously.
Common symptoms of BPH include difficulty in starting urination, a weak urine stream, a sudden urge to urinate and more frequent urination, including at night.
In two clinical trials, men with BPH who took 5 mg of Cialis once daily experienced improved BPH symptoms compared to men given a placebo. In a third study, men who experienced both ED and BPH and who took 5 mg of Cialis each day noticed improvement in both their symptoms of BPH and ED compared to men treated with placebo.
Says Scott Monroe, director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research, "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."
Patients taking nitrates, including nitroglycerin, should not use Cialis because the combination can cause an unsafe drop in blood pressure. Additionally, patients who take alpha blockers to treat BPH should not use of Cialis because the combination has not been adequately studied and because there is a risk of lowering blood pressure.
Cialis is manufactured by Eli Lilly and Co.