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注意血壓:這些降壓藥近期被召回

注意血壓:這些降壓藥近期被召回

Brittany Shoot 2018-12-09
美國食品與藥物管理局一直在自發地追蹤降壓藥的召回情況,而《財富》也是如此。

如果你感覺有許多降壓藥都經歷過召回,好吧,那是因為事實正是如此。美國食品與藥物管理局一直在自發地追蹤降壓藥的召回情況,而《財富》雜志也是如此。

消費者需要知道,這些降壓藥的名字分別是洛沙坦、纈沙坦、氨氯地平、厄貝沙坦和氫氯噻嗪。

至今為止,在美國食品與藥物管理局的要求下召回的降壓藥已經超過20種。召回的原因完全一致:它們受到了有機化學物質N-亞硝基二甲胺(N-Nitrosodimethylamine)和N-亞硝基二乙胺(N-nitrosodiethylamine)中一種或兩種的污染。這兩種物質都被劃歸可能的人類致癌物。N-亞硝基二甲胺是工業加工的副產品,而N-亞硝基二乙胺則是生產液態火箭燃料的原料,以及魚類加工和殺蟲劑制造的副產品。

今年7月起,美國食品與藥物管理局力勸消費者在咨詢醫生之前不要停止使用手頭的降壓藥,即使因為公眾對這些藥物中致癌化學物質的擔憂導致它們被持續大規模地召回。因為停止使用降壓藥可能會導致嚴重后果,只有在專業醫生的照看下才可進行。以下是美國食品與藥物管理局召回的降壓藥,以及每次召回的詳情。

洛沙坦

山德士公司(Sandoz Inc.)對批號為JB8912的單批次洛沙坦鉀-雙氰克尿塞100mg/25mg片劑進行了召回。這批片劑在2018年10月8日之后發售,有效期限至2020年6月。

纈沙坦、氨氯地平、氫氯噻嗪

含有纈沙坦的降壓藥已歷經多次召回。這是一種在緩解高血壓的常規藥物中使用的非專利成分。

包括Major Pharmaceuticals、Solco Healthcare和梯瓦制藥(Teva Pharmaceuticals)在內的公司已經召回了含有纈沙坦的多批藥品。梯瓦制藥如今還召回了所有在美國市場銷售的含有纈沙坦的非過期藥品,包括氨氯地平-纈沙坦和氨氯地平-纈沙坦-氫氯噻嗪聯合片劑。

Mylan Pharmaceuticals原本只召回了十幾批氨氯地平-纈沙坦和纈沙坦-氫氯噻嗪聯合片劑,如今又自愿召回了超過100批次的該類藥物。Mylan的召回藥品清單最近一次更新是在12月4日。

厄貝沙坦

西根制藥公司(ScieGen Pharmaceuticals Inc.)在11月初召回了75mg、150mg和300mg的厄貝沙坦。這些厄貝沙坦的規格分為30片瓶裝和90片瓶裝兩種,生產標簽上標有威斯敏斯特制藥公司(Westminster Pharmaceuticals)和金州醫藥供應公司(Golden State Medical Supply, Inc.)。(財富中文網)

譯者:嚴匡正

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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