FDA Video: Diabetes/Cardiovascular Risk with Prostate Cancer Drugs

The labeling for Gonadotropin-Releasing Hormone (GnRH) agonists is being updated to describe an increased risk of diabetes and certain cardiovascular diseases in patients being treated for prostate cancer. GnRH agonists are sold under a variety of brand names, including Lupron (leuprolide acetate), Zoladex (goserelin acetate), Trelstar (triptorelin pamoate), Viadur (leuprolide acetate), and Eligard (leuprolide acetate).

FDA is requiring that the manufacturers add this safety information to the product labels based on the Agency's review of several published studies. Most of these studies reported small, but statistically significant increased risks of diabetes and/or cardiovascular events in patients receiving these drugs. Although the risk appears to be low, healthcare professionals should evaluate their patients' risk factors for these diseases, and carefully weigh the drugs' benefits and risks when deciding on treatment for prostate cancer.

Patients being treated with these drugs should have their blood glucose and/or glycosylated hemoglobin monitored periodically. Healthcare professionals should also monitor patients for signs and symptoms of cardiovascular disease and manage them accordingly.