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Prostate cancer drugs scrutinized.

WASHINGTON -- The Food and Drug Administration is conducting a safety study of several commonly used prostate cancer drugs in the aftermath of a preliminary review that suggests an increase in the risk of diabetes and certain cardiovascular diseases in men treated with gonadotropin-releasing hormone (GnRH) agonists.

GnRH agonists--a class of medications primarily used to treat men with prostate cancer--have been associated with a small increased risk for diabetes, heart attack, stroke and sudden death in men treated with one of the medications, according to a preliminary and ongoing analysis of several studies by the FDA.

Based on its initial findings, the FDA is advising health care professionals to be aware of these potential risks and to weigh the benefits and risks of GnRH agonists when determining a treatment for patients with prostate cancer.

Patients receiving a GnRH agonist should be monitored for the development of diabetes and cardiovascular disease, says the agency, adding that such cardiovascular risk factors as smoking and increases in blood pressure, cholesterol, blood sugar and weight should be managed according to current clinical practice.

The FDA stresses that so far it has reached no conclusions about whether GnRH agonists cause an increase in the risk of diabetes and heart disease in patients receiving one of these medications to treat prostate cancer.

"While our review of these prostate cancer treatments is ongoing and there are some limitations to the data, the FDA believes it is important to tell patients and health care professionals that there may be an increased risk of serious side effects," states Robert Justice, director of the division of drug oncology products in the FDA's center for drug evaluation and research.

Medications in the GnRH class are marketed under the brand names Eligard, Lupron, Synarel, Trelstar, Vantas, Viadur, and Zoladex.

There are also several generic products available.

GnRH agonists are drugs that suppress the production of testosterone, a hormone that is involved in the growth of prostate cancer. This type of treatment is called androgen deprivation therapy.

Some GnRH agonists are also used in women to help manage the pain caused by endometriosis, to improve anemia associated with uterine fibroids prior to hysterectomy and in some cases for palliative treatment of advanced breast cancer.

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Title Annotation:RX: RETAIL PHARMACY
Publication:Chain Drug Review
Geographic Code:1USA
Date:May 24, 2010
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