Thursday, October 21, 2010 (Last Updated: 10/22/2010)
THURSDAY, Oct. 21 (HealthDay News) -- The U.S. Food and Drug Administration has notified health care professionals and consumers that the prescribing labels of gonadotropin-releasing hormone (GnRH) agonists will be updated with new safety information.
The new label changes are based on the FDA's review of six published studies that show small but statistically significant increased risks of diabetes and/or cardiovascular events among men taking GnRH agonists for the palliative treatment of advanced prostate cancer. The drugs include leuprolide acetate (Lupron, Eligard, or Viadur), goserelin acetate (Zoladex), triptorelin pamoate (Trelstar), histrelin acetate (Vantas), and nafarelin acetate (Synarel).
However, the FDA has not made any conclusions on the safety of GnRH agonists; their review is ongoing, as a cause-and-effect relationship has been difficult to confirm due to design limitations of these studies. Some GnRH agonists have also been used in women with endometriosis, advanced breast cancer, and anemia associated with uterine fibroids, as well as in children with central precocious puberty. However, there are no studies evaluating the risks of GnRH agonists in women or children with these conditions.
"Health care professionals should evaluate patients for risk factors for these diseases and carefully weigh the benefits and risks of using GnRH agonists before determining appropriate treatment for prostate cancer," according to an FDA safety alert. "Patients who are receiving treatment with GnRH agonists should undergo periodic monitoring of blood glucose and/or glycosylated hemoglobin."
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