FDA发布无需召回的含缬沙坦药品清单

翻译： JULIA  来源：Julia法规翻译 

FDA publishes a list of valsartan-containing products not part of the recall

FDA发布无需召回的含缬沙坦药品清单

Update [7/24/2018] FDA is updating health care professionals andconsumers on the agency’s progress in responding to the ongoing recalls of valsartan, which is used to treat high blood pressure and heart failure, due to the presence of NDMA. The agency has posted a list of valsartan-containing products not impacted by this recall. FDA continues to evaluate valsartan-containing products and will updatethe list of products included in the recall and the list of products not included in the recall as more information becomes available.

【更新日期20180724】FDA持续向专业卫生人员和消费者更新缬沙坦召回进展，该召回是由于缬沙坦中出现NDMA而导致的，该药品用于治疗高血压。FDA贴出了未受此次召回影响的含缬沙坦药品清单。FDA仍在继续评估含缬沙坦的药品，并将依据新获得的信息持续更新“召回范围内药品清单”和“不在召回范围内药品清单”。

（译者注：不在召回范围内药品清单点击阅读原文会跳转到FDA下载官网链接。其中包括有鲁宾、山德士、诺华在内34家：Alembic, Allergan, American, Amneal, Aphena, Apotex,A-S Medication, Aurobindo, AvKARE, AvPAK, Bryant Ranch Prepack, Camber, Cardinal,Carilion, Gavis, Jubilant Cadista labeled as Cadista, Lake Erie Medical DBAQuality Care Products LLC, Lucid, Lupin, Macleods, Mylan , Northwind, Novartis,Novel, NuCare, Ohm Laboratories, Par , PD-Rx , Preferred , Proficient Rx LP, REMEDYREPACK,Sandoz, Torrent , Unichem Pharmaceuticals (USA)。

Manufacturers of these products often produce multiple dosage strengths, however not all of them are being recalled. FDA recommends health care professionals and patients carefully check these lists. Health care professionals and patients should check this statement frequently for any updates.

这些药品的生产商通常会生产多种剂量，但并不是所有剂量均需召回。FDA建议医药专业人员和患者仔细检查这些清单。医药专业人员和患者应密切检查本声明，注意所有更新内容。

FDA reminds consumers to continue taking your current medicine until your doctor or pharmacist gives you a replacement or a different treatment option. Untreated hypertension (high blood pressure) leads to an increase in the risk of heart attacks and stroke. Untreated heart failure increasesthe risk of hospitalization and death.

FDA提醒消费者继续服用当前药品，直到你的医生或药师给你提供替代品或其它的治疗方式。高血压不进行治疗将导致心脏病发作风险增加。心脏病衰竭不进行治疗会增加住院和死亡风险。

Consumers and health care professionals should continue to report any adverse reactions with valsartan-containing products, tothe FDA’s MedWatchprogram to help the agency better understand the scope of the problem:

患者和医疗专业人员应继续通过FDA的MDEWATCH程序向FDA报告含缬沙坦药品的不良反应，以帮助FDA更好了解问题发生的范围。

• Complete and submit the report online at www.fda.gov/medwatch/report.htm

• Download and complete the appropriate form, then submit it via fax at 1-800-FDA-0178

不在召回范围的药品清单下载链接（点击阅读原文，可下载）：https://www.fda.gov/downloads/Drugs/DrugSafety/UCM614606.pdf

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