Gonadotropin-releasing hormone regulatory update

FDA will require manufacturers to update the labels for GnRH agonists to warn of an increased risk of diabetes and certain cardiovascular diseases, including heart attack, sudden cardiac death and stroke, in men receiving the drugs for prostate cancer. In May, FDA said it was reviewing the safety of GnRH agonists after data from published studies showed an increased risk of diabetes and cardiovascular disease in men receiving androgen deprivation therapy (ADT) to treat prostate cancer (see BioCentury, May 10). ...