Taiwan FDA recalls tainted sartan blood pressure medicines

10/04/2021 07:47 PM
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Image for illustrative purpose only (source: Pixabay)
Image for illustrative purpose only (source: Pixabay)

Taipei, Oct. 4 (CNA) Eight types of sartan high blood pressure medicine have been recalled after being found to contain a potential carcinogen, Taiwan Food and Drug Administration (FDA) said on Monday.

In a statement, the FDA said sales of the eight medicines have been suspended and they must be fully recalled by Nov. 4 after being found to contain a type of impurity known as azidomethyl-biphenyl-tetrazole (AZBT) -- a chemical compound that can form during the manufacture of the active ingredient in some sartan medicines.

This impurity is not a nitrosamine such as N-nitrosodimethylamine (NDMA) or N-nitrosodiethylamine (NDEA), the FDA noted.

The eight medicines -- Retonin F.C. Tablets 80mg, Diyaval F.C. Tablets 80mg "S.C.," Valsardin Film Coated Tablets 80mg "Yung Shin," Klumin F.C. Tablets 160mg, Valsardin Film Coated Tablets 160mg "Yung Shin," Retonin F.C. Tablets 160mg, Amvlo Film-Coated Tablets 5/160mg and Aprotan F.C. Tab. 150mg Standard -- must be fully withdrawn from the market by Nov. 4, the FDA said.

The above-mentioned pharmaceutical companies must submit a recall plan in three days and complete the recall by the deadline, Shirley Pan (潘香櫻), an FDA official told CNA.

The recall is not expected to have a major impact on high blood pressure patients as the eight medicines account for only 4 percent of the market in Taiwan, she said.

She advised patients currently taking any of the medicines to switch to a different brand of blood pressure medication.

According to Pan, the active ingredient used to produce the medicines is provided by a factory in China's Zhejiang province, and imports of the substance has been suspended.

The FDA has developed a special test to detect traces of AZBT in medicines treating high blood pressure that is provided by eight private institutes, Pan said.

Yen Tzung-hai (顏宗海), head of the clinical toxicology division at Linkou Chang Gung Memorial Hospital, said AZBT can cause gene mutation which increases an individual's risk of developing cancer.

(By Flor Wang and Chiang Hui-chun)


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