The government said it ordered pharmaceutical firms to temporarily suspend the making and selling of 31 medicines containing metformin, an anti-diabetic agent, after finding excessive levels of N-Nitrosodimethylamine (NDMA), a possible carcinogen.
The Ministry of Food and Drug Safety (MFDS) on Tuesday said it collected all the locally distributed drugs that used metformin as the main ingredient for inspection.
The result of the inspection revealed that 31 locally made products had NDMA exceeding the permissible level.
The ministry ordered discontinuation of manufacturing and distributing of the 31 drugs and banned doctors from prescribing them.
However, the regulator assured the public that the probability of developing cancer because of the metformin intake was only 0.21 out of 100,000. Thus, patients should not discontinue metformin medication arbitrarily without consulting a doctor or a pharmacist, the government said.
The ministry’s testing showed that 973 drug ingredients used for finished goods, produced at 12 manufacturing sites, had an NDMA level below the regulator’s criteria of 0.038ppm.
The possible carcinogen in 34 imported drugs did not exceed the permissible level. However, 31 out of 254 domestic products had NDMA levels beyond the acceptable level.
The Ministry of Health and Welfare ordered medical institutions and pharmacies not to prescribe or dispense the 31 suspended medicines.
Government data showed that 262,466 as of midnight Sunday were taking the 31 medications prescribed or dispensed from 10,379 medical institutions and 13,754 pharmacies.
The government assumed that the excessive level of NDMA might have occurred in the manufacturing of finished drugs, as NDMA in raw materials did not exceed the standard level.
“To prevent a similar case, we plan to investigate and analyze the exact cause by holding a meeting of NDMA investigation committee with experts,” the food and drug safety ministry said.
To minimize the inconvenience and cost burden of patients in the event of a safety accident caused by the 31 drugs, the ministry would also discuss with a public-private consultative body consisting of experts in the medical and pharmaceutical industries to build a proper social safety net, it added.
The ministry has been checking NDMA levels in locally distributed medicines since last year.
After some countries announced a recall of metformin due to NDMA risk in December 2019, the regulator has been collecting and testing raw materials for domestic drug manufacturing and finished products.
The ministry released a testing method for companies to conduct experiments themselves to detect NDMA levels in metformin in January.
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