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Safety review of prostate cancer drugs

The US FDA will review prostate cancer treatment, Gonadotropin-Releasing Hormones agonists, following potential health risks

The US Food and Drug Administration (FDA) has announced a review of the prostate cancer treatment, Gonadotropin-Releasing Hormones (GnRH) agonists, after the form of medication was linked to an increase in the risk of diabetes, heart attack, stroke and sudden death in men.

GnRH is manufactured as Eligard by sanofi-aventis; Lupron by Abbott; Synarel by Pfizer; Trelstar by Watson Pharmaceuticals; Vantas by Endo Pharmaceuticals; Viadur by Bayer; and Zoladex by AstraZeneca.

While the analysis of several studies looking at potential harmful effects of the treatment continues, the FDA has announced several pieces of guidance for patients and healthcare professionals to follow. These are:

• Healthcare professionals should be aware of the potential risks of GnRH agonists when determining treatment for prostate cancer patients, measuring these against the possible benefits
• Patients who are receiving GnRH agonists should be monitored for the development of heart disease and diabetes
• Cardiovascular risk factors, including smoking and increases in blood pressure, should be managed according to current clinical practice.
• Patients should not stop treatment with GnRH agonists unless otherwise instructed by a healthcare professional.

Speaking about these precautions, Dr Robert Justice, director of the division of drug oncology products in the FDA's Centre for Drug Evaluation and Research, said: "While our review of these prostate cancer treatments is ongoing and there are some limitations to the data, FDA believes it is important to tell patients and healthcare professionals that there may be an increased risk of serious side effects."

A definite causal link has yet to be established however, with the FDA saying it "has not made any 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."

GnRH agonists work by suppressing the production of testosterone, a hormone which is involved in the growth of prostate cancer. The disease is the second most common type of cancer for men in the US, with 203,415 new cases of prostate cancer estimated to be diagnosed in 2010 according to the Centers for Disease Control and Prevention.

Women and children are also prescribed some GnRH agonists for other conditions, but no known studies have evaluated the risk of diabetes and heart disease in either case.

Further information about the review, as well as additional recommendations for patients and healthcare workers, can be found on the FDA's website

The FDA has also announced the approval of Provenge - a breakthrough development in the treatment of prostate cancer.

Described as the first cancer 'vaccine', Provenge uses the novel technique of increasing the resistance of a patient's immune system to treat the disease.

4th May 2010

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