Navigation Links
FDA Approves Cialis to Treat Benign Prostatic Hyperplasia
Date:10/6/2011

SILVER SPRING, Md., Oct. 6, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction (ED), when the conditions occur simultaneously. Cialis was approved in 2003 for the treatment of ED.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Common symptoms of BPH include difficulty in starting urination and a weak urine stream; a sudden urge to urinate; and more frequent urination including at night.

The severity of symptoms of BPH can be measured using the International Prostate Symptom Score (IPSS).  In two clinical trials, men with BPH who took 5 milligrams (mg) of Cialis once daily experienced a statistically significant improvement in their symptoms of BPH compared to men who were treated with placebo. The trials based their findings on a reduction in total IPSS scores.

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 improvement in ED was measured using the Erectile Function domain score of the International Index of Erectile Function. 

"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. "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."

Cialis should not be used in patients taking nitrates, for example nitroglycerin, because the combination can cause an unsafe decrease in blood pressure. Also, 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 for the treatment of BPH, 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).

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

For more information:

Approved Drugs: Questions and Answers
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Jeff Ventura, 301-796-2807, jeffrey.ventura@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Remicade to Treat Ulcerative Colitis in Children Older Than 6 Years
2. FDA Approves Soliris for Rare Pediatric Blood Disorder
3. FDA Approves New Indications for Prolia® (Denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
4. FDA Approves Xalkori with Companion Diagnostic for a Type of Late-stage Lung Cancer
5. FDA Approves Firazyr To Treat Acute Attacks of Hereditary Angioedema
6. FDA Approves Adcetris to Treat Two Types of Lymphoma
7. FDA Approves the First Specific Treatment for Scorpion Stings
8. Cardinal Health Board of Directors Approves Cash Dividend, Elects David P. King as Director
9. FDA Tentatively Approves Intellijects Lead Product, e-cue™
10. FDA Approves New Medicine BRILINTA™ (Ticagrelor) for Use in the US
11. FDA Approves Vaccines for the 2011-2012 Influenza Season
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/16/2017)... Feb. 16, 2017  AcelRx Pharmaceuticals, Inc. (Nasdaq: ... focused on the development and commercialization of innovative ... announced that Vincent J. Angotti has ... of the company,s board of directors, effective Monday, ... decades of experience leading executive and commercial teams ...
(Date:2/16/2017)... , Feb. 16, 2017 HealthInfoNet (HIN), ... it is partnering with Orion Health on the implementation of ... Maine residents, clinical information and is ... over 500 ambulatory care sites. Pending final review ... Health,s Amadeus , a precision medicine platform that leverages ...
(Date:2/16/2017)... 16, 2017 Die Stärkung ... haben in der Medizinproduktebranche oberste Priorität. Während die ... den Blick auf unmittelbar anstehende regulatorische Änderungen auf ... diesen Regionen. ... Aufsichtsbehörden, Hersteller von ...
Breaking Medicine Technology:
(Date:2/18/2017)... ... February 17, 2017 , ... Butler Mobility invited Ken Matthews to ... other Butler products. Ken was impressed with the safety and reliability of the ... product on his show. This endorsement by Ken Matthews can be heard on ...
(Date:2/18/2017)... ... 2017 , ... Park Cities Pet Sitter President, Joette White, has been featured ... network. The episode, which was posted this week, features a 30-minute interview of ... Park Cities Pet Sitter’s being awarded the 2017 National Association of Professional Pet Sitter’s ...
(Date:2/18/2017)... (PRWEB) , ... February 18, 2017 , ... ... today provides the latest information and contact points to easily connect elderly veterans ... care, assisted living, and elder-care funding. It also conveys material on this year's ...
(Date:2/17/2017)... (PRWEB) , ... February 17, 2017 , ... ... has not kept pace. Enovate Medical has introduced an innovative workstation designed to ... of supporting nurses, the Encore Mobile EHR Workstation offers a lightweight, highly mobile, ...
(Date:2/17/2017)... ... February 17, 2017 , ... Wells Pharmacy ... electronic prescribing of controlled and non-controlled substances plus the ability to manage orders ... the United States now accept electronic prescriptions, according to the Office of the ...
Breaking Medicine News(10 mins):