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xucong0567铁杆木虫 (正式写手)
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糖尿病新药BYETTA可致急性胰腺炎
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FDA要求AMYLIN糖尿病药BYETTA（依泽那太）添加更强烈警示语 据悉，两名患者注射Amylin制药的糖尿病药Byetta后并发胰腺炎死亡，美国食品药品管理局（FDA）目前正考虑对该药添加措辞更强烈的警示语。受消息影响，Amylin股票大跌，跌幅达16%。 本周一，FDA表示已收到6份因并发出血性或坏死性胰腺炎而入院的报告，其中两名患者死亡，另外四名正在恢复。 FDA表示正与Amylin协商“在产品标签上添加措辞更强烈、更醒目的警示语”。Amylin与礼来合作营销Byetta，该药是近年来最成功的糖尿病新药。 目前尚不清楚FDA是否要求添加措辞最强烈的所谓的新“黑匣子”警示语，媒体也无法立即接触到该局代表。 Amylin与礼来都表示将全力配合FDA更新该药的标签。 ================================ Byetta Linked to Acute Pancreatitis Yael Waknine August 18, 2008 — Six new cases of hemorrhagic or necrotizing pancreatitis have been reported in patients using exenatide injection (Byetta, Amylin Pharmaceuticals, Inc), the US Food and Drug Administration (FDA) advised healthcare professionals today. All 6 cases have required hospitalization, and 2 patients have died, according to an alert issued by MedWatch, the FDA's safety information and adverse event reporting program. Four patients were recovering at the time of reporting; all had discontinued exenatide therapy. As a result of these and previously reported cases of pancreatitis, the FDA has asked the manufacturer to include information regarding acute pancreatitis in the precautions section of the safety labeling for exenatide. Because there are no signs or symptoms that distinguish acute exenatide-related hemorrhagic or necrotizing pancreatitis from less severe forms of the condition, clinicians are advised to promptly discontinue exenatide and other potentially causal drugs if pancreatitis is suspected. Patients should be informed that persistent abdominal pain, which may be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. If pancreatitis is confirmed, the condition should be treated appropriately and the patient carefully monitored until recovery. Exenatide therapy should not be resumed, and other antidiabetic therapies should be considered in patients with a history of pancreatitis. Exenatide is indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes mellitus who have not achieved adequate control with metformin, a sulfonylurea, a thiazolidinedione, or a combination of these drugs. Adverse events related to use of exenatide should be reported to the FDA's MedWatch reporting program by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787. |
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