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gonadotropin-releasing hormone agonists
Various GnRH trade names
NEW WARNING
The Food and Drug Administration (FDA) issued a safety announcement about an ongoing review of the following gonadotropin-releasing hormone (GnRH) agonists:
* goserelin acetate (Zoladex) marketed by Astra Zeneca
* histrelin acetate (Vantas) marketed by Endo Pharmaceuticals
* leuprolide acetate (Eligard) marketed by Sanofi-Aventis
* leuprolide acetate (Lupron, Lupron Depot) marketed by Abbott Laboratories
* nafarelin acetate (Synarel) marketed by Pfizer
* triptorelin pamoate (Trelstar) marketed by Watson Pharma, Inc.
The FDA is evaluating whether these drugs increase the risk of diabetes and cardiovascular diseases such as MI, sudden cardiac death, and stroke in men receiving these drugs for treatment of prostate cancer. GnRH agonists lower male hormone levels, slowing growth of prostate tumors or causing them to shrink.
The FDA issued the following recommendations:
* Health care providers should be aware of these safety issues when considering treatment options.
* Patients receiving these drugs should be monitored closely for diabetes and cardiovascular disease.
* Health care providers should address patient risk factors such as obesity, smoking, hypertension, and elevated cholesterol and blood glucose levels.
* Patients shouldn’t discontinue treatment without consulting with their health care provider.
Brought to you by Lippincott Williams & Wilkins.
