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 or considering treatment with a GnRH agonist, tell your healthcare professional if you have diabetes, heart disease, a previous heart attack or stroke, or any cardiovascular risk factors like high blood pressure, high cholesterol, or cigarette smoking. Working with your doctor to manage 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. You can report any side effects caused by your medications to FDA's MedWatch program by telephone at 1-800-332-1088 by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

New Safety Warnings Added to Gonadotropin-Releasing Hormone (GnRH) Agonists

The U.S. Food and Drug Administration (FDA) has asked manufacturers to add new warnings to the labeling of gonadotropin-releasing hormone (GnRH) agonists, a class of drugs primarily used to treat men with prostate cancer. The warnings will alert patients and their health care professionals to the potential risk of heart disease and diabetes in men treated with these medications.

This FDA action is in follow-up to a preliminary analysis that found that patients receiving GnRH agonists were at a small increased risk for diabetes, heart attack, stroke, and sudden death. These concerns were described in a May 2010 iGuard Safety Alert about the FDA's ongoing safety review of 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).

For more information, please visit: more information here

To view the May 2010 iGuard Safety Alert, please visit: more information here

Source: FDA
Publication Date: 2010-10-21
Last Updated: 2010-10-23

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