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FDA药物安全警告:含有阿利吉仑(锐思力)治疗血压药物的新警示和禁忌

时间: 2012-05-17 00:54:22 作者: 来源: 字号:
来源:http://www.fda.gov/Drugs/DrugSafety/ucm300889.htm
FDA警告糖尿病或者肾损伤的患者使用含有阿利吉仑与ACEIs或ARBs的复方制剂会有风险,糖尿病患者不允许使用含有阿利吉仑的复方制剂。同时加入新的警示:禁止肾损伤患者使用含有阿利吉仑的复方制剂。
4-20-2012] The U.S. Food and Drug Administration (FDA) is warning of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney (renal) impairment. These drug combinations should not be used (are contraindicated) in patients with diabetes. In addition, a new warning is being added to avoid use of these drug combinations in patients with kidney impairment. The labels for the aliskiren drugs are being updated based on preliminary data from a clinical trial, “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE)1.”

A list of medicines containing aliskiren is found in the Drug Facts box. Lists of approved ACEIs and ARBs are found in Tables 2 and 3.

In ALTITUDE, the risks of kidney (renal) impairment, low blood pressure (hypotension), and high potassium blood levels (hyperkalemia) in a group of patients taking aliskiren plus an ARB or ACEI increased relative to a group of patients taking placebo plus an ARB or ACEI. The preliminary data from ALTITUDE also demonstrated a slight excess of cardiovascular events (death or stroke) in the aliskiren group [see Data Summary]; however, FDA has reached no definite conclusion regarding an actual link between these drugs and death or stroke. FDA will evaluate the final trial results as well as results from other aliskiren trials and will communicate any new information when it becomes available.

The following recommendations are being added to the drug labels for aliskiren-containing products as of 4/20/12:

A new contraindication against the use of aliskiren with ARBs or ACEIs in patients with diabetes because of the risk of renal impairment, hypotension, and hyperkalemia. A warning to avoid use of aliskiren with ARBs or ACEIs in patients with moderate to severe renal impairment (i.e., where glomerular filtration rate [GFR] < 60 mL/min).

含有aliskiren(阿利吉仑)的药物有:
Amturnide (富马酸阿利吉仑、苯磺酸氢氯噻嗪、氨氯地平)
Tekturna(富马酸阿利吉仑)
Tekturna HCT (富马酸阿利吉仑和氢氯噻嗪)
Tekamlo(富马酸阿利吉仑和缬沙坦)
在2011年,共有约451,000患者从美国零售药店门诊购买约2.4万含阿利吉仑-产品处方配药。
简介:
通用名:阿利吉仑
英文名: Aliskiren
商品名: Rasilez (锐思力)
CAS No: 173334-57-1
剂型及规格:片剂,规格:150 mg,300 mg。
适应症:原发性高血压。
用法用量:成人:≥18岁:150 mg/天顿服,与餐同服。如需要可增加到300mg/天顿服。
本品由诺华公司研制,由诺华与Speedel公司合作开发,2007年3月,Tekturna (Rasilez在美国的商品名)在美国获得批准。2007年8月,Rasilez在欧盟获得批准。2008年1月,阿利吉仑与氢氯噻嗪复方药物(Tekturna HCT&reg;),首个含有Tekturna 的单片复方制剂在美国获得批准。在中国,Rasilez于2010年3月被SFDA批准。目前Rasilez已在55个国家获得上市批准
IMS数据:
2011 $290.00(前两个季度)(单位:百万美元)
2010 $438.00
2009 $290.00
2008 $144.00
2007 $40.00
诺华官网部分产品销售数据(里面有阿利吉仑数据)

诺华2008-2011年第三季度销售额.zip(1599.39k)
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