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FDA reviewing safety of GnRH agonists

May 4, 2010 12:28 AM UTC

FDA is reviewing the safety of gonadotropin-releasing hormone (GnRH) agonists after data from published studies showed an increased risk of diabetes and cardiovascular disease, including heart attack, sudden cardiac death and stroke, in men receiving androgen deprivation therapy (ADT) to treat prostate cancer. The agency said the ongoing review is preliminary and that the reported studies have design limitations that make it difficult to confirm a cause-and-effect relationship. In February, the American Heart Association, American Cancer Society and American Urological Association published a Scientific Advisory in Circulation concerning the possible relationship between ADT in prostate cancer and cardiovascular risk. ...