基因毒性杂质是真的没完没了了

小刚子

                                                                FDA更新沙坦类召回信息 20190301

Torrent again expands its voluntary recall of losartan; Hetero alsovoluntarily recalls losartan

Torrent再次扩大其主动召回氯沙坦，Hetero亦主动召回氯沙坦

Update [3/1/2019] Torrent Pharmaceuticals Limited is further expanding its voluntary recall to include 114 additional lots of losartan potassium and losartan potassium/hydrochlorothiazide combination tablets. This recall is due to unacceptable amounts of N-Methylnitrosobutyric acid (NMBA) in the losartan active pharmaceutical ingredient manufactured by Hetero Labs Limited.

【20190301更新】Torrent药业进一步扩大其主动召回，增加114批次氯沙坦钾和氯沙坦钾氢氯噻嗪复方片剂。该次召回是由于Hetero生产的氯沙坦API中含NMBA超过可接受限度。

Today, the agency also issued a press release to provide additional information about its ongoing investigation and another voluntary recall by Hetero/Camber Pharmaceuticals, which was announced on February 28, of 87 lots of losartan potassium tablets (25 mg, 50 mg and 100mg). The recalled losartan potassium and losartan potassium/hydrochlorothiazide tablets are also manufactured by Hetero, which are distributed by Camber, and contain the impurity NMBA.

今天，FDA亦发布关于其持续调查的更多信息，以及HETERO/CAMBER药业另一主动召回。该召回于20190228召回87批次氯沙坦钾片剂（25 mg, 50 mg and 100 mg）。所召回的氯沙坦钾和氯沙坦钾/氢氯噻嗪片剂亦是由HETERO生产的，由CAMBER销售，其中含有杂质NMBA。

Torrent and Hetero/Camber are only recalling lotsof losartan-containing medication with NMBA above the interim acceptable intake limits of 0.96 parts per million (ppm).

TORRENT和HETERO/CAMBER仅召回NMBA含量高于临时可接受限度0.96ppm的氯沙坦药品。

The agency also updated the list of losartan products under recall.

FDA亦更新了正在召回的氯沙坦药品清单。

Aurobindo expands its voluntary recall of valsartan and amlodipine/valsartan

阿拉宾度扩大缬沙坦和氢氯噻嗪/缬沙坦主动召回

Update [3/1/2019] Aurobindo Pharma USA is expanding its voluntary recall to include 38 additional lots of valsartan and amlodipine/valsartan combination tablets. The recall is due to unacceptable amounts of N-Nitroso diethylamine (NDEA) found inthe medicine.

【20190301更新】阿拉宾度美国公司扩大其主动召回，增加38批缬沙坦和氢氯噻嗪/缬沙坦复方片剂。此次召回是因为药品中发现NDEA超出可接受限度。

Aurobindo is only recalling lots of valsartan-containing medication where NDEA has been detected above the interim acceptable intake limit of 0.083 parts per million. FDA is working with manufacturers to reduce and remove nitrosamines from angiotensin II receptor blockers (ARBs).

阿拉宾度仅召回NDEA检出超过临时可接受摄入限度0.083ppm的氯沙坦药品。FDA正与生产商合作减少和清除ARB中的亚硝胺物。

The agency also updated the valsartan products under recall.

FDA亦更新了正在召回的缬沙坦药品清单。

FDA updates table of interim limits for nitrosamine impurities in ARBs

FDA更新ARB中亚硝胺物杂质的临时限度表

Update [2/28/2019] FDA is posting the updated table of interim acceptable intake limits for nitrosamine impurities to reflect N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) limits, which are the same as those for NDMA.

【20190228更新】FDA在此发布亚硝胺类杂质的临时可接受摄入限度，其中增加了NMBA（N-亚硝基-n-甲基-4-氨基丁酸甲酯）的限度，它与NDMA类似。

The agency will use the interim limits below to recommend manufacturers conduct a voluntary recall if laboratory testing confirms the presence of nitrosamine impurities in finished drug product. FDAis working with industry and international regulators to ensure products entering the market do not contain these impurities, but we are tolerating the impurities below the level established in the table for a short period of time to avoid a possible shortage of ARBs.

FDA建议生产商在实验室检测确认制剂中亚硝胺类杂质超出下表中临时限度时即执行主动召回。FDA正与企业和国际药监机构合作确保进入市场的药品不含有这些杂质，但我们短时间内会容许销售低于下表中杂质水平的药品以避免可能发生的ARB药品短缺。

Not all ARB products contain NDMA, NDEA or NMBA impurities, so pharmacists may be able to provide an alternative medication not affected by the recalls, or health care professionals may prescribe a different medication that treats the same condition.

并不是所有ARB药品都含NDMA、NDEA或NMBA杂质，因此药师可能可以提供未受召回影响的替代药品，专业卫生人员亦可能开出不同药品处方治疗相同病症。

Interim Limits for NDMA, NDEA, and NMBA in Angiotensin II Receptor Blockers(ARBs)

ARB中NDMA、NDEA和NMBA的临时限度

Drug 药名	Maximum Daily Dose (mg/day) 最大日剂量	Acceptable Intake 可接受摄入量NDMA (ng/day)*	Acceptable Intake 可接受摄入量NDMA (ppm)**	Acceptable Intake 可接受摄入量NDEA (ng/day)*	Acceptable Intake 可接受摄入量NDEA (ppm)**	Acceptable Intake可接受摄入量NMBA (ng/day)*	Acceptable Intake 可接受摄入量NMBA (ppm)**
Valsartan 缬沙坦	320	96	0.3	26.5	0.083	96	0.3
Losartan 氯沙坦	100	96	0.96	26.5	0.27	96	0.96
Irbesartan 厄贝沙坦	300	96	0.32	26.5	0.088	96	0.32
Azilsartan 阿齐沙坦	80	96	1.2	26.5	0.33	96	1.2
Olmesartan 奥美沙坦	40	96	2.4	26.5	0.66	96	2.4
Eprosartan 依普罗沙坦	800	96	0.12	26.5	0.033	96	0.12
Candesartan 坎地沙坦	32	96	3.0	26.5	0.83	96	3.0
Telmisartan 替米沙坦	80	96	1.2	26.5	0.33	96	1.2

* The acceptable intake is a daily exposure to a compound such as NDMA, NDEA, or NMBA that approximates a 1:100,000 cancer risk after 70 years exposure 可接受的化合物如NMDA、NDEA或NMBA的日暴露可接受摄入量为70年暴露后约10万分之一患癌风险。

** These values are based on a drug's maximum daily dose as reflected in the drug label 这些值是基于药品标签上的最大日用剂量。

Losartan distributed by Macleods Pharmaceuticals voluntarily recalled

MACLEODS药业主动召回所销售的氯沙坦

Update [2/25/2019] FDA is alerting patients and health care professionals to a voluntaryrecall of one lotof losartan potassium/hydrochlorothiazide (HCTZ) 100mg/25mg combination tablets manufactured by Macleods Pharmaceuticals. The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) found in the medicine made with active pharmaceutical ingredient manufactured by Hetero Labs Limited.

【20190225更新】FDA警示患者和专业卫生人员MACLEODS药业主动召回其生产的一批氯沙坦钾/氢氯噻嗪（HCTZ）100mg/25mg复方片剂。该次召回是因为在HETERO生产的API所生产的药品中发现NDEA超出可接受的限度。

Macleods is only recalling lots of losartan-containing medication where NDEA has been detected above the interim acceptable intake limit of 0.27 parts per million. FDA is working with manufacturers to reduce and remove nitrosamines from angiotensin II receptor blockers (ARBs).

MACLEODS仅召回检出NDEA超出可接受临时限度0.27ppm的氯沙坦药品。FDA正与生产商合作以降低和清除ARB中亚硝胺物。

The agency also updated the list of losartan products under recall.

FDA亦更新了其召回中氯沙坦

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ravenhigh

走火入魔了

wsx

华海的最初目的是不是打击这些呢？谁知道呢

小刚子

有点钻牛角尖

nmsl

wsx 发表于 2019-3-4 14:11
华海的最初目的是不是打击这些呢？谁知道呢

你也是有点厉害，损失个几十亿去打击这些

大可1980

感谢楼主分享

Arbeitehart

感谢楼主关于此事件相关信息的分享

马甲

谢谢分享。

zhiyao461

基因毒性杂质研究可以找我们——山东大学淄博生物医药研究院 15069363070 任经理

小金库

感谢分享。