The U.S. 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 in the United States 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.
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美国食品药品管理局(FDA)出于对促性腺激素释放激素(GnRH)激动剂致糖尿病、心肌梗死(MI)、卒中和猝死风险增加的担忧，要求生产商在产品说明书上增加新的警示语。GnRH激动剂主要用于男性前列腺癌的治疗。
FDA 10月20日公布的一份声明称，针对GnRH激动剂的初步及后续分析表明，接受这类药物治疗的患者出现糖尿病、MI、卒中和猝死的风险有小幅上升。
GnRH激动剂适用于晚期前列腺癌症状的姑息治疗。在美国上市的GnRH类药物的商品名包括Eligard、Lupron、Synarel、Trelstar、Vantas、Viadur和Zoladex。此外，还有数种在售的非专利产品。
2010年5月，FDA公布了早期研究结果并建议医生警惕GnRH激动剂的潜在风险，在确定前列腺癌患者的治疗方案时慎重权衡GnRH激动剂的利与弊。现行临床指南建议，对于正在接受GnRH激动剂治疗的患者，医生应定期监测其血糖和(或)糖化血红蛋白(HbA1c)。医生还应监测患者是否出现了心血管疾病的症状和体征，并予以相应的处理。
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