260,000 Users Taking 'Metformin' Diabetes Drug Found to Contain Suspected Carcinogens (Update)

31 Products Temporarily Halted Manufacturing and Sales
"Very Low Concern for Human Health"

[Asia Economy Reporter Cho Hyun-ui] Among diabetes medications containing the ingredient metformin distributed domestically, 31 items were found to contain carcinogenic substances and have been suspended from sale. Health authorities have temporarily halted the manufacturing and sales of these items and restricted their prescriptions.

On the 26th, the Ministry of Food and Drug Safety announced that after collecting and testing all raw materials and finished pharmaceutical products of metformin distributed in Korea, NDMA (N-Nitrosodimethylamine), a suspected carcinogen, was detected exceeding the control standards in 31 out of 288 finished pharmaceutical products.

However, even if the 31 items with excessive NDMA were consumed, the risk of harm to the human body was considered very low, at a level of "0.21 people per 100,000." According to the Ministry's human impact assessment, the additional probability of developing cancer from taking these products was 0.00021% (0.21 people per 100,000). The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) considers an additional cancer incidence of 1 person per 100,000 to be negligible.

The Ministry of Food and Drug Safety stated, "The possibility of additional cancer occurrence in patients who took these products is very low," and urged, "Do not stop taking the medication arbitrarily without consulting a doctor or pharmacist."

Meanwhile, all 973 manufacturing lot numbers of raw materials used in the production of finished pharmaceutical products (from 12 manufacturers) were confirmed to have NDMA levels below the provisional control standard (0.038 ppm). NDMA was not detected in 963 lots, and 10 lots were at the quantification limit level.

For finished pharmaceutical products, all 34 imported items were below the provisional control standard. Among 254 domestic items, 31 items including Gardmet Tab 100/1000 mg exceeded the provisional control standard, leading to temporary suspension of sales, recall measures, and prescription restrictions.