Navigation Links
FDA Conducting Safety Review of Commonly Used Prostate Cancer Drugs
Date:5/3/2010

Preliminary review suggests an increase in the risk of diabetes and certain cardiovascular diseases in men treated with GnRH agonists

SILVER SPRING, Md., May 3 /PRNewswire-USNewswire/ -- Gonadotropin-Releasing Hormone (GnRH) agonists, a class of medications primarily used to treat men with prostate cancer, have been associated with a small increased risk for diabetes, heart attack, stroke, and sudden death in men treated with one of the medications, according to a preliminary and ongoing analysis of several studies by the U.S. Food and Drug Administration.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

Based on initial findings, FDA advises:

  • Health care professionals should be aware of these potential risks and carefully weigh the benefits and risks of GnRH agonists when determining a treatment for patients with prostate cancer.
  • Patients receiving a GnRH agonist should be monitored for the development of diabetes and cardiovascular disease.
  • Cardiovascular risk factors such as smoking and increases in blood pressure, cholesterol, blood sugar and weight should be managed according to current clinical practice.
  • Patients should not stop treatment with a GnRH agonist unless instructed to do so by a health care professional.

At this time, FDA has not made any conclusions about whether GnRH agonists cause an increase in the risk of diabetes and heart disease in patients receiving one of these medications to treat prostate cancer.

"While our review of these prostate cancer treatments is ongoing and there are some limitations to the data, FDA believes it is important to tell patients and health care professionals that there may be an increased risk of serious side effects," said Robert Justice, M.D., director of the Division of Drug Oncology Products in FDA's Center for Drug Evaluation and Research.  

Medications in the GnRH class are marketed under the brand names Eligard, Lupron, Synarel, Trelstar, Vantas, Viadur, and Zoladex. There are also several generic products available.

The prostate gland is part of the male reproductive system. Prostate cancer is the second most common type of cancer among men in the United States, behind skin cancer, and usually occurs in older men. This year an estimated 203,415 new cases of prostate cancer will be diagnosed and about 28,372 men will die from the disease, according to the Centers for Disease Control and Prevention.

GnRH agonists are drugs that suppress the production of testosterone, a hormone that is involved in the growth of prostate cancer. This type of treatment is called androgen deprivation therapy, or ADT. Suppressing testosterone has been shown to shrink or slow the growth of prostate cancer.

Some GnRH agonists are also used in women to help manage the pain caused by endometriosis, to improve anemia associated with uterine fibroids prior to hysterectomy and in some cases for palliative treatment of advanced breast cancer. Use of these products should not exceed one year for women except in treating breast cancer. There are no known comparable studies that have evaluated the risk of diabetes and heart disease in women taking GnRH agonists.

Some GnRH agonists are also used in children to treat central precocious puberty. There are no known studies that have evaluated the risk of diabetes and heart disease in children taking GnRH agonists.

Eligard is marketed by Bridgewater, N.J.-based Sanofi-Aventis.

Lupron is marketed by Abbott Park, Ill.-based Abbott Laboratories.

Synarel is marketed by New York City-based Pfizer.

Trelstar is marketed by Corona, Calif.-based Watson Pharmaceuticals.

Vantas is marketed by Chadds Ford, Pa.-based Endo Pharmaceuticals.

Viadur is marketed by Wayne, N.J.-based Bayer Pharmaceuticals.

Zoladex is marketed by Wilmington, Del.-based AstraZeneca.

For more information:

Drug Safety Communication: Ongoing Safety Review of GnRH Agonists and Possible Increased Risk of Diabetes and Certain Cardiovascular Diseases

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm209842.htm

FDA Office of Oncology Drug Products

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091745.htm

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@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. Aon: Complex Insurance Requirements, Risk Management Needs Challenge Firms Conducting Clinical Trials Beyond Own Borders
2. Northwest Biotherapeutics Conducting Ovarian Cancer Clinical Trial With DCVax(R)-L at University of Pennsylvania
3. OrbusNeichs Genous(TM) Bio-engineered R stent(TM) Demonstrates Excellent Safety and Clinical Outcomes in High-Risk Elderly Patients
4. CareFusion, Cerner to Integrate Technologies for Improved Hospital Safety, Efficiency
5. Bio-Optronics bioPoint(TM) Patient ID Wristband System Enhancing Patient Safety
6. Logical Therapeutics Initiates Enrollment in New Gastrointestinal Safety Study in Osteoarthritis Patients
7. National Patient Safety Foundation Awards Grant to Research Safety of Computerized Ordering of Medications
8. Kendle Director of Global Safety and Pharmacovigilance, Drew Kilpatrick, PhD, Named One of Ten Notable People in R&D
9. Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk
10. Positive Long Term Data Presented at ACC 2010 Demonstrate Sustained Safety and Efficacy Advantages of the Cypher(R) Sirolimus Drug-Eluting Stent Over the Endeavor(R) Zotarolimus-Eluting Stent
11. Evidence-Based Protocols in Cancer Treatment Reduce Variation, Improve Efficacy and Safety of Care
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2016)... YORK , April 28, 2016 ... online consumer insights on healthcare, announced today that it ... their report Cool Vendor in Life Sciences, 2016, ... April 15, 2016.  The report focuses on life-science- oriented ... gain insight from patients and doctors, confirm medication ingestion, ...
(Date:4/28/2016)... 28, 2016   Acsis , a leading provider ... IT market research and advisory firm IDC has named ... MarketScape: Worldwide Pharmaceutical Track and Trace Software 2016 Vendor ... an assessment of the capabilities and business strategies of ... market. Logo - http://photos.prnewswire.com/prnh/20160427/360791LOGO ...
(Date:4/27/2016)... Inc. (Nasdaq: HOLX ) announced today ... quarter ended March 26, 2016.  GAAP diluted earnings ... non-GAAP diluted EPS of $0.47 increased 14.6%.  Revenue ... basis, and 6.3% on a constant currency basis.  ... highlighted by 14.6% growth in non-GAAP EPS," said ...
Breaking Medicine Technology:
(Date:4/29/2016)... Fl (PRWEB) , ... April 29, 2016 , ... ... recently notified by the Accreditation Council for Graduate Medical Education (ACGME) that it ... , This is the first accreditation of three residency programs that Memorial is ...
(Date:4/29/2016)... ... April 29, 2016 , ... The American ... productivity, stability, even security. Most importantly, employees are the single most important asset ... American workers so unhappy? , Just under half of American workers are emotionally ...
(Date:4/29/2016)... ... April 29, 2016 , ... Coast Dental Fort Stewart is celebrating ... new location in the Exchange Furniture Mall at 112 Vilseck Road in Fort Stewart. ... Smart TV. Plus attendees will have the opportunity to meet general dentists Thomas Richards, ...
(Date:4/29/2016)... City, Missouri (PRWEB) , ... April 29, 2016 , ... ... traditional crutches which put pressure on the armpits, the M+D Crutch evenly distributes body ... strain on their wrists and hands when using the crutches than with other crutches. ...
(Date:4/29/2016)... ... 29, 2016 , ... Dr. Robert Mondavi, one of the dentists in ... is a fast-growing field as more patients are discovering the many different ways they ... the options currently available to them and which ones might work for their smiles. ...
Breaking Medicine News(10 mins):