Didanosine与非肝硬化肝门经脉高压有关


  【24drs.com】January 29, 2010 — 美国食品药物管理局(FDA)宣布,Didanosine(Videc,VidecEC,必治妥药厂)与非肝硬化肝门静脉高压有关,药品仿单因而更新,包括这项信息。
  
  FDA的安全性信息与不良反应通报系统MedWatch今天发布警讯宣称,当局透过通报到不良反应通报系统得知非肝硬化肝门高压病例。根据这些报告,FDA已经着手修改didanosine的仿单,纳入有关非肝硬化肝门静脉高压的信息,且确保这个药物的安全使用。
  
  总共有42件非肝硬化肝门静脉高压的上市后病例被通报;这些病例中,4位病患死亡。其中2位病患死于食道静脉曲张相关的出血;1位病患死于渐进性肝脏衰竭;1位病患死于多重器官衰竭、脑出血、败血症与乳酸中毒。仅有3位接受肝脏移植后存活。使用didanosine的时间长度从几个月到数年都有。
  
  因为这些发现,FDA已经重新更新didanosine药物仿单警示与提醒事项,以及病患咨询信息部分,纳入非肝硬化肝门静脉高压相关信息。
  
  FDA建议健康照护提供者们应该与病患讨论didanosine治疗的好处与潜在风险,包括非肝硬化肝门静脉高压的风险。他们应该继续追踪病患是否发生肝门静脉高压以及食道静脉曲张。
  
  FDA坚持didanosine用于HIV感染特定病患的临床好处仍然超过其潜在风险。当局建议临床医师们与病患们应该根据个案决定是否使用didanosine。
  
  Didanosine目前已经有乳酸中毒以及肝脏肿大以及脂肪变性的黑框警示。除此之外,didanosine被认为当与其它抗病毒药物并用时,与发生肝脏毒性有关。
  
  更多信息请造访FDA的MedWatch网站。
  
  任何与didanosine有关的不良反应应该与MedWatch联系,以电话1-800-FDA-1088或传真到1-800-FDA-0178,在线通报网址为http://www.fda.gov/medwatch,或是邮寄至5600 Fishers Lane,Rockville,Maryland 20852-9787(美国地址)。

Didanosine Associated With Noncirrhotic Portal Hypertension

By Emma Hitt, PhD
Medscape Medical News

January 29, 2010 — Didanosine (Videc, VidecEC, Bristol Myers-Squibb) is associated with noncirrhotic portal hypertension, and as a result the label is being updated to include this information, the US Food and Drug Administration (FDA) announced today.

"FDA became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to FDA's Adverse Event Reporting System," states an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program. "Based on these reports, FDA has revised the didanosine drug label to include information about non-cirrhotic portal hypertension to help ensure the safe use of this drug."

A total of 42 postmarketing cases of noncirrhotic portal hypertension have been reported; of those, 4 patients died. Deaths were associated with hemorrhage from esophageal varices in 2 patients; progressive liver failure in 1 patient; and multiorgan failure, cerebral hemorrhage, sepsis, and lactic acidosis in 1 patient each. Only the 3 patients who received a liver transplant fully recovered. Duration of didanosine treatment ranged from months to years.

As a result of these findings, the FDA has revised the warning and precautions and the patient counseling information sections of the didanosine drug label to include a section on noncirrhotic portal hypertension.

The FDA recommends that healthcare providers discuss with patients the clinical benefits and potential risks of didanosine treatment, including the risk for noncirrhotic portal hypertension. They should also continue to monitor patients for the development of portal hypertension and esophageal varices.

The FDA maintains that the clinical benefits of didanosine "for certain patients with HIV continue to outweigh its potential risks." The agency recommends that clinicians and patients make the decision to use didanosine on a case-by-case basis.

Didanosine currently has a boxed warning for lactic acidosis and hepatomegaly with steatosis. In addition, didanosine has been associated with the development of liver toxicity when used in combination with other antiretroviral agents.

More information is available on the FDA's MedWatch Web site.

Adverse events related to didanosine should be communicated to MedWatch 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, Maryland 20852-9787.

    



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