FDA Review of Prostate Cancer Treatment Prompts Warning of Risk for Diabetes

Washington, DC: The FDA is advising of a label change to Gonadotropin-Releasing Hormone (GnRH) agonists, specifically that they will have new safety information added to the Warnings and Precautions section of the drug labels. This new information warns about increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer.

GnRH agonists are approved to treat the symptoms (palliative treatment) of advanced prostate cancer. The benefits of GnRH agonist use for earlier stages of prostate cancer that have not spread (non-metastatic prostate cancer) have not been established. FDA's notification to manufacturers of GnRH agonists to add this safety information is based on the Agency's review of several published studies. 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.

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Published on Oct-20-10