Navigation Links
FDA Conducting Safety Review of Commonly Used Prostate Cancer Drugs

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.


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

FDA Office of Oncology Drug Products

Media Inquiries: Erica Jefferson, 301-796-4988,

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:
(Date:6/26/2016)... Jazz Pharmaceuticals plc (Nasdaq: JAZZ ... Antitrust Improvements Act of 1976, as amended ("HSR"), with ... ("Celator"; Nasdaq: CPXX ) expired effective June ... As previously announced on May 31, 2016, Jazz ... under which Jazz Pharmaceuticals has commenced a tender offer ...
(Date:6/24/2016)... , June 24, 2016  Consumers have taken ... regulators/payers have placed more emphasis on patient outcomes. ... support programs in the pharmaceutical industry have evolved ... Consequently, pharmaceutical companies are focusing on becoming more ... providing products and services that improve health. ...
(Date:6/24/2016)... , June 24, 2016   Bay Area ... Network,s Dean Center for Tick Borne Illness ... and Rehabilitation, MIT Hacking Medicine, University of California, ... today announced the five finalists of Lyme ... disease.  More than 100 scientists, clinicians, researchers, entrepreneurs, ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... , ... Comfort Keepers® of San Diego, CA is excited to announce they ... to drive cancer patients to and from their cancer treatments. Comfort Keepers provides ... life and ongoing independence. Getting to and from medical treatments is one of ...
(Date:6/24/2016)... , ... June 24, 2016 , ... People across the ... Genome magazine’s Code Talker Award, an essay contest in which patients and their families ... to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education ...
(Date:6/24/2016)... NY (PRWEB) , ... June 24, 2016 , ... ... Haute Living, is proud to recognize Dr. Barry M. Weintraub as a prominent ... “the most beautiful women in the world, and the most handsome men, look ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... the Frederick area economy by obtaining investment capital for emerging technology companies. ... years that have already resulted in more than a million dollars of capital ...
(Date:6/24/2016)... ... June 24, 2016 , ... Venture Construction Group (VCG) ... held on June 20th at the Woodmont Country Club at 1201 Rockville Pike, ... organization dedicated to helping service members that have been wounded in battle and their ...
Breaking Medicine News(10 mins):