GnRH agonists labeling updated to include diabetes and cardiovascular risk

The FDA has notified manufacturers of 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 (eg, heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer. This request is based on the FDA's review of several published studies.

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 HbA1C, as well as monitoring for signs and symptoms suggestive of development of cardiovascular disease.

GnRH agonists are approved for the palliative treatment of advanced prostate cancer. They include Eligard (leuprolide acetate, from sanofi-aventis), Lupron (leuprolide acetate, from Abbott), Trelstar (triptorelin pamoate, from Watson), Viadur (leuprolide acetate, from Bayer), and Zoladex (goserelin acetate, from AstraZeneca).

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm230359.