Safety Alerts & Recalls

What does this mean?

GnRH agonists are used to treat serious conditions and for most patients, the benefits of this therapy will continue to outweigh the risks. If you are receiving a GnRH agonist, you should continue with your treatment - do not stop your treatment with GnRH agonists unless told to do so by your doctor or other healthcare professional.

If you are receiving a GnRH agonist and have diabetes, heart disease, a previous heart attack or stroke, or any cardiovascular risk factors like high blood pressure, high cholesterol, or cigarette smoking, you may wish to review this safety alert with your doctor - managing these risk factors will help to reduce your risk of new or worsening diabetes and heart disease.

If you have any concerns or questions about GnRH agonists, please talk to your doctor or other healthcare professional.

FDA Announces Ongoing Safety Review of Gonadotropin-Releasing Hormone (GnRH) Agonists

The U.S. Food and Drug Administration (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. The agency is reviewing data from published studies comparing outcomes in men receiving GnRH agonists to treat prostate cancer versus men not undergoing this treatment. At this time, it is unknown whether these same findings apply to women receiving GnRH agonists.

GnRH agonists are drugs that lower male hormones, which has the effect of shrinking prostate tumors or slowing the growth of prostate cancer. GnRH agonists are also used by women in the management of endometriosis. GnRH agonists include leuprolide (Eligard, Lupron, Viadur), goserelin (Zoladex), triptorelin (Trelstar), histrelin (Supprelin, Vantas), and nafarelin (Synarel).

At this time, FDA has not concluded that receiving GnRH agonists increases the risk of diabetes and certain cardiovascular diseases. The FDA will continue to review information relating to this safety concern and notify the public as more information becomes available.

For more information, please visit: more information here

To view a detailed list of FDA approved GnRH agonists, please visit: more information here

Source: FDA
Publication Date: 2010-05-03
Last Updated: 2010-05-03

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