Preliminary report suggests link between GnRH agonists and diabetes, cardiovascular disease in men.
Gonadotropin-releasing hormone (GnRH) agonists have been linked with a small increased risk for diabetes, heart attack, stroke, and sudden death in some men receiving the drugs for prostate cancer, according to FDA’s preliminary and ongoing analysis of several studies. GnRH agonists are used in men with prostate cancer to suppress the production of testosterone in androgen deprivation therapy.
The agency has issued the following advisories:
Health professionals should be aware of these potential risks and should carefully weigh the benefits and risks of GnRH agonists when determining treatment for patients with prostate cancer.Patients using a GnRH agonist should be monitored for the development of diabetes or cardiovascular disease.Health professionals should manage cardiovascular risk factors such as smoking and increases in blood pressure, cholesterol, blood glucose, and weight according to current clinical practice.Patients should not stop treatment with a GnRH agonist unless instructed to do so by a
health professional.
FDA has not yet made any conclusions about whether GnRH agonists cause increased risk of diabetes or heart disease. “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, in a news release.
Brand-name GnRH agonists include Eligard (leuprolide—sanofi-aventis), Lupron (leuprolide—Abbott), Synarel (nafarelin—Pfizer), Trelstar (triptorelin—Watson), Vantas (histrelin—Endo), Viadur (leuprolide—Bayer), and Zoladex (goserelin—AstraZeneca). Several generic products are also available.
Some GnRH agonists are also used in women to help manage pain caused by endometriosis, to improve anemia associated with uterine fibroids, and to provide palliative treatment for advanced breast cancer. Additionally, some are used in children to treat central precocious palsy. No known comparable studies have evaluated the risk of diabetes or cardiovascular disease in women or in children.
