FDA Drug Safety Communication

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FDA Date: 5/3/10

GnRH Agonists (leuprolide acetate) FDA Drug Safety Communication

Ongoing Safety Review of GnRH Agonists and Possible Increased Risk of Diabetes and Certain Cardiovascular Diseases

FDA is evaluating whether Gonadotropin-Releasing Hormone (GnRH) Agonists may increase the risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer. GnRH agonists--sold under the brand names Lupron (leuprolide acetate), Zoladex (goserelin acetate), Trelstar (triptorelin pamoate), Viadur (leuprolide acetate), Vantas (histrelin acetate), Eligard (leuprolide acetate) and Synarel (nafarelin acetate)--are drugs that lower male hormones, which has the effect of shrinking prostate tumors or slowing the growth of prostate cancer. This therapy is known as Androgen Deprivation Therapy or ADT.

FDA's review is ongoing. The agency has not made any conclusions about GnRH agonists and whether they increase the risk of diabetes and cardiovascular disease in patients receiving these medications for prostate cancer.

At this time, FDA recommends that:

- Healthcare professionals should be aware of these potential safety issues and carefully weigh the benefits and risks of GnRH agonists when determining treatment and follow the recommendations in the drug label when prescribing GnRH agonists.

- Patients receiving GnRH agonists should be monitored for development of diabetes and cardiovascular disease.

- Healthcare professionals should manage cardiovascular risk factors for patients, such as smoking and increases in blood pressure, cholesterol, blood sugar, and weight, according to current clinical practice.

View the full FDA Drug Safety Communication on FDA.gov