Navigation Links
Drugs for Enlarged Prostate May Raise Risk of Aggressive Cancer
Date:6/10/2011

By Steven Reinberg
HealthDay Reporter

THURSDAY, June 9 (HealthDay News) -- The U.S. Food and Drug Administration is calling for new warning labels on a class of drugs used primarily to treat enlarged prostates, because the medications may raise the risk of developing an aggressive form of prostate cancer.

In a statement released Thursday, the agency said the drugs involved include popular medications sold under the brand names Proscar and Propecia (sold by Merck & Co.) and Avodart and Jalyn (sold by GlaxoSmithKline).

According to the FDA, almost 5 million men were prescribed one of these medications between 2002 and 2009. Of these, nearly 3 million men were between the ages of 50 and 79.

The agency is advising doctors not to start patients on these drugs until prostate cancer -- which can mimic the symptoms of an enlarged prostate -- and other urological conditions have been ruled out.

According to the agency, this new warning is based on the results of two large prostate cancer trials.

Although these trials did not include Propecia, which is prescribed to treat hair loss in men, its label is also being updated. However, the FDA said "the applicability of the Avodart and Proscar studies to Propecia, is currently unknown."

All of these drugs are part of a class of medications called 5-alpha reductase inhibitors (5-ARI). According to the FDA, Proscar, Avodart and Jalyn are approved to treat symptoms of enlarged prostate, while Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate. Propecia is a lower-dose version of Proscar.

Merck issued a statement Thursday on the FDA ruling.

"Merck stands behind the demonstrated safety and efficacy of Proscar [finasteride, 5mg] and Propecia [finasteride, 1mg]. Both products have been prescribed to millions of men, with Proscar prescribed to those suffering from benign prostatic hyperplasia (BPH or enlarged prostate) since 1992, and Propecia prescribed to men with male pattern hair loss since 1997," the company statement said. "Merck's goal is to ensure the product labeling includes all relevant trial information to help health-care professionals and their patients make informed treatment decisions."

Less than a year ago, GlaxoSmithKline asked the FDA to approve the use of Avodart to prevent prostate cancer, although the FDA declined that request in January. The company based its reasoning on the results of one of the trials on which the agency is now basing its new warning.

In addition to this new side effect, recent research has shown that Proscar, Propecia and Avodart are all associated with increasing the risk of erectile dysfunction in men who take the medications.

Commenting on the FDA warning, prostate cancer expert Dr. Anthony D'Amico, chief of genitourinary radiation oncology at Brigham and Women's Hospital in Boston, said, "I think that the warning is appropriate. The risk is very small, but not zero."

"What both studies show conclusively is there is about a 1 percent increase in being diagnosed with high-grade prostate cancer if you got these drugs -- even though you are less likely to get a low-grade cancer."

Why that is is not clear, D'Amico said. "But I think the warning is fair," he added.

The drugs really do work in preventing prostate cancer, D'Amico said. "You have to weigh the 24 percent reduction against the 1 percent increased incidence of high-grade disease," he said.

"These drugs should only be used in men who have an additional indication to take them beyond prostate cancer prevention," D'Amico said.

More information

For more on prostate cancer, visit the American Cancer Society.

SOURCES: Anthony D'Amico, M.D., chief of genitourinary radiation oncology at Brigham and Women's Hospital, Boston; June 9, 2011, statement, U.S. Food and Drug Administration; June 9, 2011, statement, Merck & Co., Whitehouse Station, N.J.


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Treatment for Abuse of Anti-Anxiety Drugs Tripled Over 10 Years
2. Two Drugs Shown to Prolong Survival in Advanced Melanoma Cases
3. Epilepsy Drugs Risk of Birth Defects May Be Dose-Dependent
4. Widely Used Heart Drugs Linked to Better Breast Cancer Outcomes
5. Illegal Drugs Easy to Buy on the Internet, U.K. Study Finds
6. CT angiography for low-risk heart patients leads to more drugs and tests without benefit
7. Younger Docs More Likely to Prescribe Drugs for Heart Disease: Study
8. Standard Heart Drugs Wont Ease Pulmonary Hypertension
9. Half of prostate cancers could potentially benefit from new type of cancer drugs, U-M study finds
10. Kids Taking ADHD Drugs at Low Risk for Heart Problems: Study
11. Younger doctors prescribe more drugs to reduce heart risk but offer less lifestyle advice
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Drugs for Enlarged Prostate May Raise Risk of Aggressive Cancer
(Date:1/20/2017)... ... January 20, 2017 , ... “Code Word: Chocolate Biscuit”: a biographical account following a man ... is the creation of published author, Marlyn Ivey, born in Lynn Haven, Florida and at ... school and at 19 years of age, he joined the Navy and got married right ...
(Date:1/20/2017)... (PRWEB) , ... January 20, 2017 , ... ... vPEP ® Oscillating Positive Expiratory Pressure (OPEP) device, was featured in a study ... Doug Pursley, MEd, RRT-ACCS, FAARC, “Analysis of Three Oscillating Positive Expiratory Pressure ...
(Date:1/20/2017)... ... ... a beautiful and enchanting tale that teaches children the true meaning of Christmas. “Journey to ... City, and a devoted woman of faith. , “Becoming a parent changes you. In ... my mind for years, but actually doing it might have been a while in coming ...
(Date:1/20/2017)... ... , ... “The Land of More and More”: a brilliant story for ... shares the simple and achievable answer. “The Land of More and More” is the ... Church in Angola, Indiana where he works with the children’s ministry department. , ...
(Date:1/19/2017)... ... 20, 2017 , ... Today, the Centers for Medicare & Medicaid Services (CMS) ... Payment Models (APMs) in 2017. Clinicians who participate in APMs are paid for the ... of the Administration’s effort to build a system that delivers better care and one ...
Breaking Medicine News(10 mins):
(Date:1/20/2017)... 20, 2017  Palladian Health, a leading provider ... launch of an opioid management program which assists ... and helps stem the growing tide of dependence ... treat chronic non-cancer pain (back pain, neck pain, ... lack of evidence regarding long-term effectiveness. ...
(Date:1/20/2017)... January 20, 2017 Avillion LLP, a co-developer ... Mark Weinberg , MD MBA as Chief Medical Officer. Dr ... USA . ... Dr Weinberg has spent more than 17 years as a ... companies to micro-cap biotech. Over the course of his career, he ...
(Date:1/19/2017)... YORK , Jan. 19, 2017 Report ... Ophthalmic Devices Market? Which areas are going to grow ... potential revenues to 2026, assessing data, trends, opportunities and ... and graphs. Discover the most lucrative areas in the ... lets you assess forecasted sales across the all the ...
Breaking Medicine Technology: