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Prostate Cancer Drugs Raise Heart, Diabetes Risks, FDA Says

Oct 21, 2010 | Parker Waichman LLP

The makers of prostate cancer drugs called GnRH agonists have been directed by the US Food & Drug Administration (FDA) to add warnings to their labels regarding an increased risk of heart problems and diabetes. GnRH agonists are sold under the brand names Eligard, Lupron, Synarel, Trelstar, Vantas, Viadur, and Zoladex, and are also available as generic versions.

GnRH agonists are approved to treat the symptoms (palliative treatment) of advanced prostate cancer. The drugs suppress the production of testosterone, a hormone involved in the growth of prostate cancer. Suppressing testosterone has been shown to shrink or slow the growth of prostate cancer.

According to the FDA, the benefits of GnRH agonist use for earlier stages of prostate cancer that have not spread (non-metastatic prostate cancer) have not been established.

In May, the FDA said that a preliminary and ongoing analysis found that patients receiving GnRH agonists were at a small increased risk for diabetes, heart attack, stroke, and sudden death. Information on the increased risks will be included in the Warnings and Precautions sections of the drugs’ labels.

While the risk of developing diabetes and cardiovascular diseases appears to be low in men receiving GnRH agonists for prostate cancer, the FDA said it is important for healthcare professionals to evaluate patients for risk factors for these diseases. Healthcare professionals should always carefully weigh the benefits and risks of using GnRH agonists before determining appropriate treatment for prostate cancer.

Patients who are receiving treatment with GnRH agonists should undergo periodic monitoring of blood glucose levels, the FDA said. Increased blood glucose levels may represent development of diabetes or worsening of blood glucose control in patients with diabetes. Healthcare professionals should also monitor patients for signs and symptoms suggestive of development of cardiovascular disease and manage according to current clinical practice.


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