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FDA Drug Safety Communication: Update to Ongoing Safety Review of GnRH Agonists and Notification to Manufacturers of GnRH Agonis

Posted Oct 19 2010 2:13pm


Safety Announcement

Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary
References

Safety Announcement

[10-20-2010] The U.S. Food and Drug Administration (FDA) has notified the manufacturers of the Gonadotropin-Releasing Hormone (GnRH) agonists of the need to add new safety information to the Warnings and Precautions section of the drug labels. This new information warns about increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer. FDA’s notification to manufacturers of GnRH agonists to add this safety information is based on the Agency’s review of several published studies 1-7 , described in the Agency’s Ongoing Safety Review of GnRH Agonists and possible increased risk of diabetes and certain cardiovascular diseases , issued in May 2010.

GnRH agonists are approved to treat the symptoms (palliative treatment) of advanced prostate cancer. The benefits of GnRH agonist use for earlier stages of prostate cancer that have not spread (non-metastatic prostate cancer) have not been established.

Although the risk for diabetes and cardiovascular diseases appears to be low in men receiving GnRH agonists for prostate cancer, it is important for healthcare professionals to evaluate patients for risk factors for these diseases. Healthcare professionals should always carefully weigh the benefits and risks of using GnRH agonists before determining appropriate treatment for prostate cancer.

Patients who are receiving treatment with GnRH agonists should undergo periodic monitoring of blood glucose and/or glycosylated hemoglobin (HbA1c). Increased blood glucose levels may represent development of diabetes or worsening of blood glucose control in patients with diabetes. Healthcare professionals should also monitor patients for signs and symptoms suggestive of development of cardiovascular disease and manage according to current clinical practice.

Additional Information for Patients

  • GnRH agonists are sold as the brand names – Lupron, Zoladex, Trelstar, Viadur, and Eligard.
  • Before receiving GnRH agonists, tell your healthcare professional if you have diabetes, heart disease, a previous heart attack or stroke, or any cardiovascular risk factors like high blood pressure, high cholesterol, or cigarette smoking.
  • If you have any concerns about receiving these medicines, talk to your healthcare professional.
  • Report any side effects from the use of GnRH agonists to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.

Additional Information for Healthcare Professionals

  • Most of the studies reviewed by FDA reported small, but statistically significant increased risks of diabetes and/or cardiovascular events in patients receiving GnRH agonists.
  • Carefully weigh the known benefits and risks of GnRH agonists when determining appropriate treatment for prostate cancer.
  • Monitor blood glucose and/or glycosylated hemoglobin periodically in patients receiving GnRH agonists.
  • Monitor patients for signs and symptoms suggestive of development of cardiovascular disease.
  • Ensure that cardiovascular risk factors such as cigarette smoking, high blood pressure, high cholesterol, high blood sugar, and being overweight are managed according to current clinical practice.
  • Report adverse events involving GnRH agonists to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of this page.

 
Data Summary

FDA’s decision to notify sponsors that new safety information be added regarding increased risk of diabetes and certain cardiovascular diseases to the Warnings and Precautions section of the drug labels for GnRH agonists is based on the Agency’s review of several published studies 1-7 and a Science Advisory 8 described in the Agency’s May 2010 Ongoing Safety Review of GnRH Agonists and possible increased risk of diabetes and certain cardiovascular diseases .

References

  1. Keating NL, O'Malley JO, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol. 2006;24:4448-4456.
  2. Keating NL, O'Malley JO, Freedland SJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy: observational study of Veterans with prostate cancer. J Natl Cancer Inst. 2010;102:39-46.
  3. Tsai HK, D'Amico AV, Sadetsky N, Chen M-H, Carroll PR. Androgen deprivation therapy for localized prostate cancer and the risk of cardiovascular mortality. J Natl Cancer Inst. 2007;99:1516-1524.
  4. Saigal CS, Gore JL, Krupski TL, Hanley J, Schonlau M, Litwin MS, and the Urologic Diseases in America project. Androgen deprivation therapy increases cardiovascular morbidity in men with prostate cancer. Cancer. 2007;110:493-500.
  5. Van Hemelrijck M, Garmo H, Holmberg L, Ingelsson E, Bratt O, Bill-Axelson A, et al. Absolute and relative risk of cardiovascular disease in men with prostate cancer: results from the population-based PCBaSe Sweden. J Clin Oncol. 2010;28:3448-56.
  6. Alibhai SMH, Duong-Hua M, Sutradhar R, Fleshner NE, Warde P, Cheung AM, et al. Impact of androgen deprivation therapy on cardiovascular disease and diabetes. J Clin Oncol. 2009;27:3452-3458.
  7. Efstathiou JA, Bae K, Shipley WU, Hanks GE, Pilepich MV, Sandler HM, Smith MR. Cardiovascular mortality after androgen deprivation therapy for locally advanced prostate cancer: RTOG 85-31. J Clin Oncol. 2008;27:92-99.
  8. Levine GN, D'Amico AV, Berger P, Clark PE, Eckel RH, Keating NL, et al on behalf of the American Heart Association Council on Clinical Cardiology and Council on Epidemiology and Prevention, the American Cancer Society, and the American Urological Association. Androgen-deprivation therapy in prostate cancer and cardiovascular risk: a science advisory from the American Heart Association, American Cancer Society, and American Urological Association: endorsed by the American Society for Radiation Oncology. Circulation. 2010;121:833-840.
    
 

Contact Us

  • Report a Serious Problem

  • 1-800-332-1088
  • 1-800-FDA-0178 Fax
  • MedWatch Online

    Regular Mail: Use postage-paid FDA Form 3500

    Mail to: MedWatch 5600 Fishers Lane

    Rockville, MD 20857

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