高血壓藥中查出致癌物

A pharmaceutical company in Zhejiang province has reported finding an impurity that can cause cancer in a drug it makes as an ingredient in blood pressure medications, the State Drug Administration said last Sunday. The products have been recalled.

國(guó)家藥監(jiān)局上周日稱，浙江一家制藥公司報(bào)告，該公司生產(chǎn)的一款降壓藥原料藥被發(fā)現(xiàn)含有可致癌的雜質(zhì)。目前該產(chǎn)品已被召回。

Huahai Pharmaceutical reported on July 6 that it had discovered traces of a chemical impurity called NDMA in valsartan, the active ingredient in drugs widely used to treat hypertension, the administration said. Valasartan normally contains no such contaminant.

藥監(jiān)局稱，7月6日，華海藥業(yè)股份有限公司報(bào)告其纈沙坦原料藥中檢出微量化學(xué)雜質(zhì)N-亞硝基二甲胺(NDMA)，纈沙坦是一種被廣泛應(yīng)用于降壓藥的原料藥，正常情況下不含有雜質(zhì)。

Experiments have shown that NDMA can cause cancer in animals, but there is little evidence ofa problem for humans, the administration said. The chemical is widely used elsewhere -- for example, in products such as salted foods.

相關(guān)部門表示，實(shí)驗(yàn)表明，NDMA可能會(huì)導(dǎo)致動(dòng)物患上癌癥，但幾乎沒有證據(jù)表明會(huì)導(dǎo)致人類出現(xiàn)該問題。這種化學(xué)物質(zhì)在其他地方被廣泛使用--例如，在鹽類食品等產(chǎn)品中。

The administration said the presence of NDMA does not present serious health risks forpatients who have used products from Huahai Pharmaceutical. However, measures must betaken to stop production and recall the involved products.

該管理部門稱，NDMA的存在不會(huì)給使用華海藥業(yè)產(chǎn)品的患者帶來嚴(yán)重的健康風(fēng)險(xiǎn)。但是必須采取措施來停止生產(chǎn)并召回所涉及的產(chǎn)品。

Huahai's production technique was approved by the United States Food and Drug Administration and European Medicines Agency.

華海藥業(yè)的生產(chǎn)技術(shù)得到了美國(guó)食品藥品監(jiān)督管理局和歐洲藥品管理局的認(rèn)證。

The authority has inspected six other companies in China that produce valsartan, and no meaningful traces of NDMA were detected.

當(dāng)局已經(jīng)對(duì)中國(guó)另外六家生產(chǎn)纈沙坦的公司展開了調(diào)查，并沒有檢測(cè)到NDMA的痕跡。