National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
May 4, 2010 • Volume 7 / Number 9

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FDA Update

FDA Reviewing Potential Risks of Commonly Used Prostate Cancer Drugs

The FDA advised health care professionals yesterday to be aware of potential health risks that may be associated with gonadotropin-releasing hormone (GnRH) agonists, drugs commonly used to treat prostate cancer. The agency based the announcement on its ongoing review of GnRH agonists, which, in several studies, have been associated with a small increased risk for diabetes, heart attack, stroke, and sudden death. Last year, for instance, a retrospective study conducted in Sweden found a small increased risk of fatal and nonfatal heart attacks, as well as other cardiac problems, such as arrhythmias and heart failure, in men with prostate cancer treated with GnRH agonists.

GnRH agonists work by blocking the production of testosterone, a hormone that, like estrogen in some women with breast cancer, can fuel tumor growth. In addition to weighing the risks and benefits of treatment with these drugs, the FDA also advised that patients undergoing treatment with GnRH agonists be monitored for the development of diabetes and cardiovascular disease. The ongoing review has not established whether these drugs can cause these conditions, the agency stressed. But the FDA believes “it is important to tell patients and health care professionals that there may be an increased risk of serious side effects,” said Dr. Robert Justice from the FDA Center for Drug Evaluation and Research.

The GnRH agonists currently on the market include Eligard, Lupron, Synarel, Trelstar, Vantas, Viadur, and Zoladex, as well as several generic options.

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