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FDA: Stop prescribing combo drugs with high-dose acetaminophen FDA:停止处方含大剂量对乙酰氨基酚药物  

2014-02-20 08:10:33|  分类: 药物学 |  标签: |举报 |字号 订阅

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By: ALICIA AULT, Internal Medicine News Digital Network


The Food and Drug Administration is turning to doctors, dentists, and pharmacists to accomplish what some drug manufacturers won’t help it do.


In 2011, the agency recommended manufacturers cease marketing of acetaminophen/opioid combination products with more than 325 mg of acetaminophen per dose, in an effort to reduce the risk of severe liver injury. Not all manufacturers complied.


Now, the agency on Jan. 14 issued a MedWatch recommendation that health care providers refrain from prescribing combinations with larger acetaminophen doses. The recommendation goes further, urging pharmacists to contact prescribers when they receive a prescription for a combination product with more than 325 mg of acetaminophen per dose to discuss a substitute product with a lower acetaminophen dose.


"Inadvertent overdose from prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which result in liver transplant or death," the agency said, in a statement.


In the same 2011 notice, the FDA is requiring prescription acetaminophen combinations to carry a boxed warning on the potential for liver damage.


Acetaminophen-containing prescription combinations are among the most-prescribed pharmaceuticals in the United States, and include products such as Vicodin (acetaminophen/hydrocodone), Percocet (acetaminophen/oxycodone), and Tylenol with codeine.


The FDA has been examining acetaminophen since at least 2002. The recommendations of a joint meeting of several advisory committees in 2009 resulted in the 2011 policy changes and recommendations.


The agency now has sent letters to manufacturers that have not lowered the acetaminophen dose warning them that the FDA will withdraw approval of those products.


Physicians can report adverse events or side effects related to the use of acetaminophen products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online or at 800-332-1088.


译文

美国食品药品管理局(FDA)正在动员医生、牙医和药剂师完成一些制药企业不肯主动去做的事情。


含对乙酰氨基酚的处方复方制剂是美国最常见的处方药物之一,包括维柯丁(对乙酰氨基酚/氢可酮)、Percocet(对乙酰氨基酚/羟考酮)以及扑热息痛与可待因的复方制剂。“在美国,疏忽所致处方含过量对乙酰氨基酚的复方药物大约导致近一半对乙酰氨基酚相关肝衰竭病例的发生,一些患者甚至需要肝脏移植或发生死亡,”该机构在声明中说。


FDA最迟于2002年开始对对乙酰氨基酚进行考核。2009年一些顾问委员会的联合会议提出的建议促使2011年改变政策和提出新的建议。


2011年,FDA建议生产企业停止销售每剂含对乙酰氨基酚剂量超过325 mg的对乙酰氨基酚/阿片类药物复方制剂,目的是降低严重肝脏损害风险。但并非所有生产厂家服从这一指令。在2011年针对该问题的通告中,FDA要求处方的对乙酰氨基酚复方制剂标签中增加关于肝脏损害可能的加框警告


目前,该机构于1月14日发布了一项MedWatch建议,动员医疗卫生服务人员停止处方含较大剂量对乙酰氨基酚的复方制剂。这一建议进一步鼓励药剂师在接到每剂含对乙酰氨基酚325 mg以上的复方制剂处方时,应联系处方医生,讨论是否改为一种含对乙酰氨基酚剂量较低的替代产品。


该机构目前已致函警告未降低对乙酰氨基酚剂量的企业,指出如不遵照指令,FDA将收回这些产品的上市许可证。


医生可在线或致电800-332-1088,将与使用对乙酰氨基酚产品有关的不良事件或副作用向FDA的MedWatch安全性信息和不良事件报告项目报告。

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