Based on new information showing an increased risk of diabetes and certain cardiovascular diseases in male patients receiving Gonadotropin-releasing Hormone (GnRH) agonists for the treatment of prostate cancer, the FDA accordingly assigned new safety information to be added to the Warnings and Precautions section of the drug labels.
While GnRH agonists are approved for the treatment of the symptoms – palliative treatment – of advanced prostate cancer, the benefits of their use in earlier stages of prostate cancer that have not spread, non-metastatic, have not yet been established.
The FDA’s decision to add this new information is based on studies reviewed by the Agency which reported small but statistically significant increased risks of diabetes and/or cardiovascular events in those receiving GnRH agonists.
Healthcare professional should henceforth evaluate patients for possible risks of these diseases and carefully weigh the benefits and risks of using GnRH agonists before determining appropriate treatment for prostate cancer.
Patients who are receiving GnRH agonist treatment should undergo periodic monitoring of blood glucose and/or glycosylated haemoglobin (HbA1c). Healthcare professionals should also monitor patients for signs and symptoms indicative of cardiovascular disease development and respond to these accordingly.