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:5/6/2017)... -- May is Stroke Awareness Month and Omron Healthcare is ... to prevent a stroke: monitor and manage your blood ... Prevention, undetected and uncontrolled hypertension is a leading risk ... in personal heart health technology, recently evolved its mission ... stroke and is advancing a national public education effort ...
(Date:5/4/2017)... and SAN DIEGO , May 4, ... (ACOG) 2017 Annual Clinical and Scientific Meeting— OBP Medical ... medical devices, today announced the launch of a new ... OfficeSPEC and ER-SPEC vaginal specula. Already ... extra-small and extra-large sizes makes OBP Medical,s line of ...
(Date:5/3/2017)...  Kalorama Information notes that transplant diagnostics is ... and this is projected to continue to 2021. ... or bone marrow transplants require histocompatibility between the ... this task. This according to a new report ... various PCR-based methodologies, Sanger sequencing and NGS used ...
Breaking Medicine Technology:
(Date:5/29/2017)... ... 29, 2017 , ... Thomas Dickerson, Ed. D, FACHE, chief ... of the Board of Directors for the Radiology Business Management Association , ... Board President Jim Hamilton, MHA, CMM, FRBMA, an administrator and business manager for ...
(Date:5/28/2017)... ... , ... HYPERAMS, LLC announced it will perform the inventory liquidation ... Ohio. The sale began this week and the inventory is expected to sell quickly. ... and medical accessories, including blood pressure cuffs, stethoscopes, CPR masks, as well as blank ...
(Date:5/27/2017)... , ... May 26, 2017 , ... A May 8 ... visit a doctor for colds or respiratory issues that are not responsive to antibiotics ... pressure on doctors may be largely responsible for the problem both in Canada and ...
(Date:5/27/2017)... ... ... Most us are familiar with the sound of occasional popping joints that ... shows that certain people who experience consistent joint popping, grating and grinding are ... opportunity to treat patients before the problem becomes pronounced, potentially hedging off more severe ...
(Date:5/26/2017)... VA (PRWEB) , ... May 26, 2017 , ... ... pleased to announce a new educational seminar to focus on current legislative activity ... News(LEARN) seminar will begin at 1 p.m. Sunday, Sept. 10, and will continue ...
Breaking Medicine News(10 mins):