FDA conducting safety review of gonadotropin-releasing hormone (GnRH) agonists

The FDA has notified healthcare professionals and patients of a preliminary and ongoing review which suggests an increase in the risk of diabetes and certain cardiovascular diseases in men treated with gonadotropin-releasing hormone (GnRH) agonists for the treatment of prostate cancer. 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. 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.

Based on initial findings, the FDA is advising that:

  • Healthcare 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 healthcare professional.

GnRH agonists are primarily used in the treatment of men with prostate cancer. Brand name products include Eligard (leuprolide acetate, from Sanofi Aventis), Lupron (leuprolide acetate, from Abbott), Synarel (nafarelin acetate, from Pfizer), Trelstar (triptorelin pamoate, from Watson), Vantas (histrelin acetate, from Endo), and Zoladex (goserelin acetate, from AstraZeneca).

For more information visit www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm209842.htm.