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:10/12/2017)... 12, 2017   Divoti USA will engrave ... the standard of the latest FDA requirements, which stipulates new criteria ... Anyone in need of Medical ID jewelry such as Medical ID ... are engraved in terms of the new FDA requirements . ... Divoti offers this dark mark ...
(Date:10/11/2017)... 2017  Caris Life Sciences ® , a leading ... of precision medicine, today announced that St. Jude Medical ... Alliance™ (POA) as its 17 th member. Through ... Crosson Cancer Institute will help develop standards of care ... profiling, making cancer treatment more precise and effective. ...
(Date:10/10/2017)... received FDA 510(k) clearance in May 2017 for its highly anticipated ... for endoscopy environments. An innovative secondary monitor solution, ZeroWire Mobile ... the improvement of patient outcomes, procedural efficiency, and the lowering of ... ... By ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader ... been awarded a contract by the Center for Medicare and Medicaid Services (CMS). ... the enterprise use of Agile methodologies in a consistent and high value manner ...
(Date:10/13/2017)... ... ... “America On The Brink”: the Christian history of the United States and the loss ... author, William Nowers. Captain Nowers and his wife, Millie, have six children, ten ... the Navy. Following his career as a naval aviator and carrier pilot, he ...
(Date:10/12/2017)... San Francisco, CA (PRWEB) , ... October 12, ... ... and Dr. Cheng, are now treating sleep apnea using cutting-edge Oventus ... sleep apnea, a serious sleep disorder characterized by frequent cessation in breathing. Oral ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... products to meet the demand of today’s consumer and regulatory authorities worldwide. From ... probiotic experts and tested to meet the highest standard. , These products ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of ... Carol Friedman, PhD, FACMI, during the Opening Session of AMIA’s Annual Symposium in Washington, ... In honor of Morris F. Collen, a pioneer in the field of medical informatics, ...
Breaking Medicine News(10 mins):