Locally produced antihypertensive medication containing the active ingredient valsartan has also been found to contain a potential carcinogen – N-Nitrosodimethylamine (NDMA) – in the government report released Monday.
The Ministry of Food and Drug Safety announced that it would suspend manufacturing and sales of 59 valsartan containing products produced by Korea’s Daebong Life Sciences. The update is likely to affect about 181,286 patients.
The latest findings add on to the government’s ban of 115 medicines used to be produced by 54 companies using valsartan manufactured by China’s Zhejiang Huahai.
The updated report showed valsartan manufactured by Daebong had been found to have more than 0.3ppm of NDMA, exceeding the ministry’s safety standard. Daebong imports and refines the raw materials of valsartan from China’s Zhuhai Rundu Pharmaceutical.
The ministry said that it would suspend the sales of 22 companies selling 59 antihypertensive medications made from the raw materials supplied by Daebong. The recalled drugs include Pfizer’s Norvasc V and valsartan-containing medications sold by JW Pharmaceutical, Huons, Daehwa Pharmaceutical, and Dongwha Pharmaceutical.
The agency also noted that it would ensure that medical institutions notify affected patients individually and guide them to change their medication. Physicians in the field have voiced their anger regarding the latest valsartan detection in Korean products.
“Patient complaints have gone through the roof as we told them that the replacement medications could also have carcinogens,” said a physician at a local clinic who declined to be named. “The firms that made the drugs and the Ministry of Food and Drug Safety who approved it should take joint responsibility for this problem, but it’s the doctors who have become the bad guys.”
The ministry said about one out of 11,800 patients who have taken one of the banned valsartan products produced by Zhejiang Huahai at the maximum dose of 320 mg is at risk for developing cancer.
<© Korea Biomedical Review, All rights reserved.>