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注意血压:这些降压药近期被召回

注意血压:这些降压药近期被召回

Brittany Shoot 2018-12-09
美国食品与药物管理局一直在自发地追踪降压药的召回情况,而《财富》也是如此。

如果你感觉有许多降压药都经历过召回,好吧,那是因为事实正是如此。美国食品与药物管理局一直在自发地追踪降压药的召回情况,而《财富》杂志也是如此。

消费者需要知道,这些降压药的名字分别是洛沙坦、缬沙坦、氨氯地平、厄贝沙坦和氢氯噻嗪。

至今为止,在美国食品与药物管理局的要求下召回的降压药已经超过20种。召回的原因完全一致:它们受到了有机化学物质N-亚硝基二甲胺(N-Nitrosodimethylamine)和N-亚硝基二乙胺(N-nitrosodiethylamine)中一种或两种的污染。这两种物质都被划归可能的人类致癌物。N-亚硝基二甲胺是工业加工的副产品,而N-亚硝基二乙胺则是生产液态火箭燃料的原料,以及鱼类加工和杀虫剂制造的副产品。

今年7月起,美国食品与药物管理局力劝消费者在咨询医生之前不要停止使用手头的降压药,即使因为公众对这些药物中致癌化学物质的担忧导致它们被持续大规模地召回。因为停止使用降压药可能会导致严重后果,只有在专业医生的照看下才可进行。以下是美国食品与药物管理局召回的降压药,以及每次召回的详情。

洛沙坦

山德士公司(Sandoz Inc.)对批号为JB8912的单批次洛沙坦钾-双氰克尿塞100mg/25mg片剂进行了召回。这批片剂在2018年10月8日之后发售,有效期限至2020年6月。

缬沙坦、氨氯地平、氢氯噻嗪

含有缬沙坦的降压药已历经多次召回。这是一种在缓解高血压的常规药物中使用的非专利成分。

包括Major Pharmaceuticals、Solco Healthcare和梯瓦制药(Teva Pharmaceuticals)在内的公司已经召回了含有缬沙坦的多批药品。梯瓦制药如今还召回了所有在美国市场销售的含有缬沙坦的非过期药品,包括氨氯地平-缬沙坦和氨氯地平-缬沙坦-氢氯噻嗪联合片剂。

Mylan Pharmaceuticals原本只召回了十几批氨氯地平-缬沙坦和缬沙坦-氢氯噻嗪联合片剂,如今又自愿召回了超过100批次的该类药物。Mylan的召回药品清单最近一次更新是在12月4日。

厄贝沙坦

西根制药公司(ScieGen Pharmaceuticals Inc.)在11月初召回了75mg、150mg和300mg的厄贝沙坦。这些厄贝沙坦的规格分为30片瓶装和90片瓶装两种,生产标签上标有威斯敏斯特制药公司(Westminster Pharmaceuticals)和金州医药供应公司(Golden State Medical Supply, Inc.)。(财富中文网)

译者:严匡正

If it seems like there have been a lot of blood pressure medicine recalls, well, that’s because there have been. The United States Food and Drug Administration (FDA) has been keeping track of blood pressure drugs recalled voluntarily, and so has Fortune.

Among the hypertension medication names consumers need to know are losartan, valsartan, amlopidine, irbesartan, and hydrochlorothiazide.

By now, the list has grown to more than half a dozen types of hypertension drugs under FDA recall. The cause for all of these blood pressure drug recalls is the same: contamination of one of either two organic chemicals, N-Nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), both of which are classified as a probable human carcinogen. NDMA is an industrial processing byproduct. NDEA is used to make liquid rocket fuel, and it is also a byproduct of fish processing and pesticide manufacturing.

Since July, the FDA has urged consumers to consult their physicians before discontinuing use of the tablets they have on hand, even if their blood pressure meds are part of this ongoing, massive recall over concerns of the cancer-causing chemical found in various amounts in all of these drugs. But discontinuing use of hypertension medication can have serious implications and should only be done under the care of a medical professional. Here are the names of the blood pressure drugs under FDA recall and more about each callback.

Losartan

A single-lot recall is in effect for Sandoz Inc.’s losartan potassium hydrochlorothiazide 100 milligram/25 milligram tablets with the lot number JB8912. The pills were distributed after Oct. 8, 2018 and bear an expiration date 06/2020.

Valsartan, amlodipine, hydrochlorothiazide

There have been numerous recalls for hypertension drugs that contain valsartan, an off-patent ingredient used in generic medications to treat high blood pressure.

Companies including Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals have recalled numerous lots of medications that contain valsartan, and Teva has now recalled all non-expired valsartan-containing products it sells on the U.S. market, including amlodipine-valsartan and amlodipine-valsartan-hydrochlorothiazide combination tablets.

Mylan Pharmaceuticals has also expanded its initial recall of more than a dozen lots of over 100 lots of amlodipine-valsartan and valsartan-hydrochlorothiazide combination tablets now under voluntary recall. A full list of recalled Mylan products, updated as of Dec. 4.

Irbesartan

Irbesartan doses of 75 mg, 150 mg, and 300 mg were called by ScieGen Pharmaceuticals Inc. at the beginning of November. Irbesartan tablets are packed in 30- and 90-count bottles and labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc.

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