诺和诺德公司在一封信中说到，一项近期的评估显示，一部分基层医疗服务提供者没有充分意识到与Victoza使用相关的严重风险。

　　Liraglutide于2010年1月首先由FDA批准，为用于治疗2型糖尿病的的首个每日1次胰高血糖素样肽-1类似物。治疗方法是与饮食和锻炼相结合，改善一线治疗失败的2型糖尿病患者的血糖控制。

　　据MedWatch通报系统于6月13日公布的安全信息，Liraglutide可引起两种性别的大鼠和小鼠剂量依赖和治疗持续时间依赖的临床相关甲状腺 C细胞瘤。目前还不清楚liraglutide是否可导致人类患甲状腺C细胞肿瘤，包括甲状腺髓样癌，临床或非临床试验不能排除人类的相关性。此外，在关于liraglutide临床研究中，接受liraglutide治疗的患者较对照药物有更多胰腺炎病例。

　　FDA建议，如果患者体检或因其他原因进行颈部影像发现甲状腺结节，应当转诊到内分泌专家作进一步评估。

　　FDA表示，虽然对接受liraglutide治疗的患者常规监测血清降钙素的价值还不确定，但如果血清降钙素水平升高，患者病应转诊到内分泌专家作进一步的评估。

　　在开始Liraglutide治疗和增加剂量后，FDA敦促医生仔细观察患者的胰腺炎症状和体征（包括持久性的严重腹部疼痛，有时可放射到背部，可能伴或不伴有呕吐）。

　　作为药物被批准时的风险评估与减轻策略的一部分，FDA要求进行心血管安全性评价研究，以明确评估liraglutide对高风险人群的安全性。该公司还被要求使用健康索赔数据库进行为期5年的流行病学研究，以评估除低血糖、胰腺炎及过敏反应之外的甲状腺癌以及其他癌症风险。

Victoza (liraglutide [rDNA origin]) Injection: REMS - Risk of Thyroid C-cell Tumors, Acute Pancreatitis

[Posted 06/13/2011]

AUDIENCE: Endocrinology, Family Practice

ISSUE: Novo Nordisk reminded healthcare professionals of important safety information about Victoza (liraglutide [rDNA origin]) injection required in a Risk Evaluation and Mitigation Strategy (REMS). The letter is being sent because a recent assessment of healthcare providers showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza.

Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Additionally, in clinical trials studying Victoza, there were more cases of pancreatitis in patients treated with Victoza than in patients treated with comparators.

BACKGROUND: FDA may require a REMS for newly or already approved prescription drug product when FDA determines that a REMS is necessary to ensure the benefits of a drug outweigh the risks of the drug. Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

RECOMMENDATION: Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation.

After initiation of Victoza, and after dose increases, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, and which may or may not be accompanied by vomiting).

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm¹


• Download form² or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178