05/10/2010 - News

FDA Provides Update on Prostate Cancer Drugs

By: June Chen, MD


Gonadotropin-releasing hormone agonists are a type of drug used to treat prostate cancer. The U.S. Food and Drug Administration (FDA) is now conducting an ongoing safety review of gonadotropin-releasing hormone agonists to evaluate evidence suggesting an increased risk for diabetes and heart disease in men with prostate cancer who are treated with these drugs.

The FDA was alerted of the potential safety risk of these prostate cancer drugs after several studies suggested a small, but statistically significant, increase in the risk for diabetes, heart attack, stroke, and sudden death among men treated with one of the prostate cancer drugs. In the FDA’s ongoing review, it has not been concluded that gonadotropin-releasing hormone agonists increase the risk of diabetes and heart disease in prostate cancer patients.

The following gonadotropin-releasing hormone agonists are approved for the palliative treatment of advanced prostate cancer: leuprolide, triptorelin, histrelin, and nafarelin. Another gonadotropin-releasing hormone agonist, goserelin, is approved for the palliative treatment of advanced prostate cancer, as well as for treatment of local prostate cancer.

While the FDA performs its investigations, the FDA recommends that healthcare professionals adhere to the recommendations on the drug label when prescribing these prostate cancer drugs, carefully weigh the risks and benefits when choosing prostate cancer treatment, carefully monitor prostate cancer patients receiving these drugs for diabetes and cardiovascular events, and manage cardiovascular risk factors in patients receiving these prostate cancer drugs.

The bottom line is healthcare professionals and prostate cancer patients should be aware that there might be an increased risk of serious side effects with gonadotropin-releasing hormone agonists. Although gonadotropin-releasing hormone agonists are used for other conditions, there are no studies that have looked at the risk for diabetes and heart disease in women or children.



U.S. Food and Drug Administration Postmarket Drug Safety Information for Patients and Providers, 3 May 2010.


Created on: 05/10/2010
Reviewed on: 05/10/2010

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