BETHESDA, MD 21 October 2010—FDA announced yesterday that it is requiring revisions to the labeling for gonadotropin-releasing hormone (GnRH) agonists to warn that they increase the risk of diabetes and cardiovascular events in men undergoing androgen deprivation therapy with the drugs as palliative care for advanced prostate cancer.
The changes will appear in the "Warnings and Precautions" sections of the labeling for GnRH agonists sold as Lupron, Zoladex, Trelstar, Viadur, and Eligard, according to FDA.
According to FDA, the labeling change is supported by study findings that demonstrate "small, but statistically significant increased risks of diabetes and/or cardiovascular events in patients receiving GnRH agonists."
FDA in May announced that it was examining whether androgen deprivation therapy in men with prostate cancer increases the risk of diabetes mellitus, myocardial infarction, sudden cardiac death, and stroke. At that time, the agency recommended that health care providers continue to manage elevated blood pressure, cholesterol, and glucose levels in men undergoing androgen deprivation therapy.
FDA now recommends periodic monitoring of blood levels of glucose, glycosylated hemoglobin, or both in patients being treated with a GnRH agonist. Patients should also be monitored for the development of cardiovascular disease and managed as clinically appropriate.
The agency also wants patients to tell their health care provider if they have diabetes, heart disease, or known cardiac risk factors.