Audience: urology, oncology health care professionals, patients
May 3, 2010 — The FDA notified health care professionals and patients of a preliminary and ongoing review that suggests an increase in the risk of diabetes and certain cardiovascular diseases in men treated with GnRH agonists. These drugs suppress the production of testosterone, a hormone that is involved in the growth of prostate cancer.
Most of the studies reviewed by the FDA reported small, but statistically significant increased risks of diabetes and/or cardiovascular events in patients receiving GnRH agonists. As the FDA's review is ongoing, the agency has not come to any conclusions about GnRH agonists and whether they increase the risk of diabetes and cardiovascular disease in patients receiving these medications.
Some GnRH agonists are also used in women and in children for indications other than those above. There are no known comparable studies that have evaluated the risk of diabetes and heart disease in women and children taking GnRH agonists.
Health care professionals and patients should be aware of these potential safety issues and carefully weigh the benefits and risks of GnRH agonists when determining treatment choices. The FDA recommends that patients receiving GnRH agonists should be monitored for the development of diabetes and cardiovascular disease. Patients should not stop their treatment with GnRH agonists unless told to do so by their health care professional.
May 3, 2010 — FDA drug safety communication
May 3, 2010 — FDA news release