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FDA Calls for New Warnings on Some Prostate Cancer Drugs
Date:10/21/2010

By Steven Reinberg
HealthDay Reporter

WEDNESDAY, Oct. 20 (HealthDay News) -- The U.S. Food and Drug Administration on Wednesday called for new warnings on the labels of widely used hormonal prostate cancer drugs because of evidence of a slight increased risk of heart disease and diabetes in the men who take them.

The FDA first announced in May that it was reviewing the prostate cancer drugs known as gonadotropin-releasing hormone (GnRH) agonists, citing this possible increased risk. These medications suppress the production of testosterone, a hormone that can spur the growth of prostate cancer. The drugs include Eligard, Lupron, Synarel, Trelstar, Vantas, Viadur, Zoladex and several generic products.

Hormone-based therapy is not a cure for prostate cancer, because tumors can eventually become resistant to the therapy. However, the therapy can extend survival.

So, should the new label warnings deter men from enrolling on hormone-based treatment? Experts say the cardiovascular risk is something to consider, but the therapy does have real benefits.

"Clearly these drugs are needed for the treatment of prostate cancer," Dr. Mark Soloway, chair of urology at the University of Miami Miller School of Medicine, stressed in May.

"Lowering the male hormone is by far the most effective treatment," he said, but at the same time "there should be more judgment in prescribing GnRH agonists."

Soloway believes that any increased risk for heart disease and diabetes would be due to a lowering of testosterone. "At this point, it makes sense to use hormone therapy when necessary, but not for everyone that has prostate cancer," he said.

Another expert, Dr. Nelson Neal Stone, a clinical professor of urology and radiation oncology at Mount Sinai School of Medicine in New York City, agreed that, "there is evidence that low testosterone can induce metabolic syndrome," which in turn raises men's risk for diabetes a
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