Product Liability

Prostate cancer drug linked to risk of diabetes, heart attack, stroke, death

A medication primarily used to treat men with prostate cancer has been associated with a slightly increased risk for diabetes, heart attack, stroke and sudden death. The findings are preliminary and are part of an ongoing analysis of several studies by the Food and Drug Administration (FDA).

The drug is among a class of medications known as Gonadotropin-Releasing Hormone (GnRH) agonists, which includes drugs 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, or ADT. Suppressing testosterone has been shown to shrink or slow the growth of prostate cancer.

Based on the preliminary data, the FDA is advising that health care professionals be aware of the potential risks and carefully weight the benefits and risks of GnRH agonists when determining a treatment for patients with prostate cancer. Patients receiving GnRH agonist should be monitored for the development of diabetes and cardiovascular disease. Cardiovascular risk factors such as smoking and increases in blood pressure, cholesterol, blood sugar and weight should be managed according to current clinical practice. The FDA also advises patients not to stop taking the treatment unless instructed to do so by a health care professional.

“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, M.D., director of the Division of Drug Oncology Products in FDA’s Center for Drug Evaluation and Research.

GnRH agonists are most commonly prescribed to men for the treatment of prostate cancer. However, 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. There are no known comparable studies that have evaluated the risk of diabetes and heart disease in women taking GnRH agonists.

Some GnRH agonists are also used in children to treat central precocious puberty. There are no known studies that have evaluated the risk of diabetes and heart disease in children taking GnRH agonists.