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:2/27/2017)... 27, 2017  A landmark study led ... MBBS, PhD, FRACS, of  Sydney Heart and Lung ... will be published in the February 28, 2017 issue ... College of Cardiology . According to the study, which involved 37,720 ... surgery technique (anOPCABG) reduced postoperative stroke by ...
(Date:2/27/2017)... TAMPA, Fla. , Feb. 27, ... medical device company focused on developing cerebral embolic ... the members of the FDA,s Circulatory System Devices ... acknowledgement of the need for cerebral protection following ... "The statements shared by this FDA panel support ...
(Date:2/27/2017)... -- Now in its seventh year, the Pharmaceutical ... successful at developing and commercialising innovation. ... The Index can be summarised ... two different companies in early phase, which would make the ... of each company,s performance between 2011 and 2016, the 2017 ranking sees ...
Breaking Medicine Technology:
(Date:2/28/2017)... , ... February 28, 2017 , ... ... premiere organization in North America for the scientific development, healthcare training and clinical ... Annual Meeting & Scientific Session on September 16-17 in Greenville, SC at the ...
(Date:2/28/2017)... Lake City, Utah (PRWEB) , ... February 28, 2017 , ... ... Month is a time for everyone to reaffirm their commitment to improving cardiovascular health ... cause of death for men and women. Every year, one in four deaths are ...
(Date:2/28/2017)... ... February 28, 2017 , ... Roxanna ... 4:30-5:30 p.m. at the 11th Annual RISE Nashville Summit. RISE Nashville is the ... analytics, and engagement strategies. , The discussion will include best practices for accurate ...
(Date:2/27/2017)... ... ... Robert E. Burke, MD, PhD, had a successful career as a pediatrician and ... have led him down a much different path. , In his book, “Beyond the ... Dr. Burke shares a personal account of the tribulations he encountered on his path ...
(Date:2/27/2017)... ... 2017 , ... Elisa Guajardo Carothers is not your typical author. She went from working as ... Now, she writes about God, when she isn’t swimming as a performing mermaid. , Her ... BS! (Before Satan),” she offers a comedic look at the dysfunctions of God’s family, before ...
Breaking Medicine News(10 mins):