Eight types of sartan medicine to treat high blood pressure have been recalled after being found to contain a potential carcinogen, the Food and Drug Administration (FDA) said on Monday.
The FDA said in a statement that sales of the 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 or N-nitrosodiethylamine, the FDA said.
The suspended brands are Retonin FC Tablets 80mg, Diyaval FC Tablets 80mg “SC,” Valsardin Film Coated Tablets 80mg “Yung Shin,” Klumin FC Tablets 160mg, Valsardin Film Coated Tablets 160mg “Yung Shin,” Retonin FC Tablets 160mg, Amvlo Film-Coated Tablets 5/160mg and Aprotan FC Tablets 150mg Standard.
The pharmaceutical companies producing the medicines must submit a recall plan within three days and complete the recall by the deadline, FDA official Shirley Pan (潘香櫻) told the Central News Agency.
The recall is not expected to have a major affect on people with high blood pressure, as the affected medicines account for only 4 percent of the domestic market, she said.
She advised people using any of the medicines to switch to a different brand.
The active ingredient used to produce the medicines is provided by a factory in China’s Zhejiang Province, Pan said, adding that imports of the substance have been suspended.
The FDA has developed a test to detect traces of AZBT in high-blood pressure medicines, she said, adding that he tests are considered by eight private institutes.
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 could increase the risk of cancer.
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