The Food and Drug Administration wants manufacturers to add new warnings to the labels of gonadotropin-releasing hormone agonists – used mainly to treat men with prostate cancer – because of concerns about increased risks of diabetes, MI, stroke, and sudden death.
The new warnings are the result of a preliminary and ongoing analysis showing that patients on gonadotropin-releasing hormone (GnRH) agonists are at a small increased risk for diabetes, MI, stroke, and sudden death, according to an agency statement released on Oct. 20.
GnRH agonists are indicated for the palliative treatment of symptoms of advanced prostate cancer. Medications in the GnRH class are marketed under the brand names Eligard, Lupron, Synarel, Trelstar, Vantas, Viadur, and Zoladex. Several generic products are also available.
In May 2010, the agency released the early findings and advised physicians to be aware of these potential risks and carefully weigh the benefits and risks of GnRH agonists when determining a treatment for patients with prostate cancer.
Physicians should periodically monitor blood glucose and/or glycosylated hemoglobin (HbA1c) in patients who are receiving treatment with GnRH agonists. Physicians should also monitor patients for signs and symptoms suggestive of development of cardiovascular disease and manage them, according to current clinical practice.
Adverse events involving GnRH agonists should be reported to the FDA MedWatch program at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by calling 800-332-1088.