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Gov’t pulls more possibly carcinogenic drugs

Aug 07,2018
The Ministry of Food and Drug Safety on Monday ordered the recall of 59 high blood pressure treatments made by Korean pharmaceutical company Daebong LS for containing traces of a possible carcinogen.

The products contain Valsartan, a key ingredient in drugs commonly prescribed for high blood pressure. One by-product of Valsartan production is N-nitrosodimethylamine (NDMA), a “potent carcinogen in experimental animals,” according to the World Health Organization.

The U.S. Department of Health and Human Services classifies NDMA as a “reasonably anticipated human carcinogen,” according to the U.S. Environmental Protection Agency.

Some Valsartan products supplied by Daebong LS contained more than 0.3 parts-per-million (ppm) of NDMA, which the Ministry of Food and Drug Safety said was a worrying amount.

“Our standard is that any product containing more than 0.3 ppm may not be safe,” the ministry said in a statement, “as this is the same standard used by the European Medicines Agency.”

The 59 products are sold by 22 companies. The ministry uploaded the list of products and retailers on its website. The latest announcement brings the total number of Valsartan products banned by the Korean government to 174. The ministry said it is looking into about 50 more Valsartan products and will announce its findings soon. The first ban came last month after an international recall of Valsartan products supplied by Zhejiang Huahai Pharmaceuticals, a Chinese company. They, too, contained worrying amounts of NDMA.

After the finding, the Korean ministry began researching other Valsartan products that might contain high amounts of NDMA. “In our inspection, we did not take action in recalling products that contain less than 0.3 ppm of NDMA,” the ministry said.

The Valsartan products by Daebong LS were the only ones found to contain more than 0.3 ppm of NDMA in the ministry’s investigation so far. They contained 0.12 to 4.89 ppm of NDMA.

Daebong LS imported substances from Zhuhai Rundu Pharmaceutical, another company in China, the ministry said, to make Valsartan products.

“We think the source of the problem may be at the substances imported from the Chinese company,” said Lee Won-sik, head of the pharmaceutical safety bureau, at the ministry.

The Valsartan products by Daebong LS made up 10.7 percent of the Valsartan products in the market here for the past three years, according to the ministry, and 181,286 people have been prescribed Valsartan drugs from the company.

“According to our studies, we found that if people have taken Valsartan products with worrying amounts of NDMA for three years, the likelihood of getting cancer is one out of 11,800,” the ministry said.

Further prescriptions of the 59 products were automatically banned as of Monday, the ministry said, “through the Drug Utilization Review system, which shares up-to-date information on drugs with medical professionals.”

The Ministry of Health and Welfare will deliver the list of 181,286 people who have been prescribed a Valsartan product supplied by Daebong LS to hospitals and clinics, who will “be in touch with the patients individually” to inform them that the product has been recalled and to request they “visit the clinic or hospital to be prescribed again with a different product.”

BY ESTHER CHUNG, LEE ESTHER [chung.juhee@joongang.co.kr]