GnRH Agonist Safety Is Under Review

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The FDA is conducting a safety review of gonadotropin-releasing hormone (GnRH) agonists, a class of drugs used primarily as a treatment for prostate cancer.

A preliminary review suggests that the use of these drugs is associated with a small increase in the risk of diabetes, myocardial infarction, stroke, and sudden death.

“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 health care professionals that there may be an increased risk of serious side effects,” said Robert Justice, MD, Director of the Division of Drug Oncology Products in FDA's Center for Drug Evaluation and Research.

Based on initial findings, FDA advises that health care professionals be aware of the potential risks and weigh carefully the benefits and risks of GnRH agonists when deciding on treatment for men with prostate cancer. FDA also recommends that patients receiving a GnRH agonist should be monitored for the development of diabetes and cardiovascular disease.

Furthermore, cardiovascular risk factors, such as smoking and increases in BP, cholesterol, blood glucose, and weight should be managed according to current clinical practice.

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