抗HIV药 Ziagen 和Videx 会增加心脏病发作风险

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FDA MedWatch Alerts
Ziagen (abacavir) and Videx (didanosine)
March 27, 2008
2008.3.27
Audience: Infectious disease specialists, other healthcare professionals, patients
[Posted 03/27/2008] The FDA issued an Early Communication about recent findings of The Data Collection on Adverse Events of Anti-HIV Drugs Study. Data analyses from this study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking Ziagen (abacavir) or Videx (didanosine) as part of their drug therapy. The study is a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia. Patients in this study are being followed to evaluate the short and long term adverse effects of treatment with anti-HIV drugs. FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until the FDA’s review is complete, health care professionals should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking.
读者：感染疾病专家，其他医疗保健专家和患者。FDA发布了一项早期通讯，是关于抗HIV药物副作用研究的数据资料的最新发现。该研究的数据分析表明，服用塞进（阿巴卡伟）或惠妥滋（地达诺新）的感染HIV的患者发生心脏病的危险性会更高。此研究是关于33347名感染HIV-1的患者的大样本观察性研究，患者来自北美，欧洲和澳大利亚。对患者进行随访以评估抗HIV药物治疗的短期和长期副作用。FDA继续评估阿巴卡伟和地达诺新的总风险和收益。该评估可能导致需要修改药物的标签。在FDA的回顾完成之前，医疗护理专家应该评估每一个抗HIV逆转录病毒药物的潜在风险和收益。

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.
该早期通讯和FDA告知公众关于药物进行性安全性回顾的使命相一致。回顾一完成，FDA就会把结论和建议传达给公众。


抗HIV药 Ziagen 和Videx 会增加心脏病发作风险
3月27日FDA发布消息称，一项关于抗HIV药物副作用的研究数据显示，服用塞进（阿巴卡伟）或惠妥滋（地达诺新）的HIV感染者发生心脏病的风险明显增高。
这项大规模横断面研究对来自北美、欧洲和澳大利亚的33347名HIV-1感染者进行长期随访，评估抗HIV药物的短期和长期副作用。FDA将继续评估阿巴卡伟和地达诺新的总体风险及获益，评估结果有可能导致这两种药物的标签被修改。在FDA审查完成之前，医疗保健人员应该评估HIV感染者使用的每一个抗逆转录病毒药物的潜在风险和获益。
该消息符合FDA告知公众关于药物安全性审查的承诺。审查一完成，FDA就会把结论和建议传达给公众。