FDA更新缬沙坦召回 20181127

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FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and irbesartanFDA更新血管紧张素II受体拮抗剂（ARB）缬沙坦、氯沙坦和厄贝沙坦召回

FDA alerts patients and health care professionals to Teva’s recall of valsartan products due to NDEA

FDA警示患者和卫生专业人员--TEVA因NDEA召回其缬沙坦药品

Update [11/27/2018] FDA is alerting patients and health care professionals to Teva Pharmaceuticals’ voluntary recall of valsartan-containing products manufactured using active pharmaceutical ingredient (API) from Mylan Pharmaceuticals. Mylan voluntarily recalled valsartan- containing products on November 20.

更新【20181127】FDA在此警示患者和卫生专业人员—TEVA药业主动召回使用了MYLAN药业API的含有缬沙坦药品。MYLAN已于11月20日主动召回含有缬沙坦的药品。

Teva is recalling all lots of amlodipine and valsartan combination tablets and amlodipine, valsartan, and hydrochlorothiazide (HCTZ) combination tablets due to the presence of N-Nitrosodiethylamine (NDEA). Teva has recalled other valsartan-containing products in recent months due to the presence of N-Nitrosodimethylamine (NDMA). With this recall, Teva has now recalled all their unexpired valsartan-containing products from the U.S.market.

TEVA召回药品为所有批号氨氯地平与缬沙坦复方片剂，和氨氯地平缬沙坦与氢氯噻嗪（HCTZ）复方片剂，召回原因是发现NDEA。TEVA已于近期因发现NDMA而召回其它含缬沙坦药品。加上此次召回，TEVA已召回其所有在美国市场上含有缬沙坦的效期内药品。

The agency continues to investigate and test all angiotensin II receptor blocker (ARBs) for the presence of NDMA and NDEA and is taking swift action when it identifies these impurities that are above acceptable levels.

FDA将继续调查和检测所有ARB药品中NDMA和NDEA，如发现此类杂质超出可接受水平将立即采取措施。

FDA has updated the list of valsartan products under recall and the list of valsartan products not under recall. The agency reminds patients taking this medication or any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option. It also is important to know that not all ARBs contain NDMA or NDEA, so pharmacists may be able to provide a refill of medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition.

FDA已更新了其召回与未召回的缬沙坦清单。FDA提醒正在服用此药品或任何已召回ARB药品的患者在其药师提供替代药品之前或其医生提供替代疗法之前继续服用其当前药品。并非所有ARB均含有NDMA或NDEA，因此药师有可能可以提供未受召回影响的其它药品，医生亦有可能重新开具治疗同一症状的不同药品。

本文摘自 Julia 法规翻译