The Ministry and Food and Drug Safety (MFDS) announced Tuesday that it detected unacceptable levels of a potential carcinogen called N-Nitrosodimethylamine (NDMA) in 31 metformin products, spurring the health authority to temporarily halt production and sales of the drugs in the country.
The agency also noted that the likelihood of metformin, a type 2 diabetes therapy, causing cancer is low and warned that patients should not stop taking prescribed metformin without the consultation of a medical professional.
According to the MFDS, the Health Impact Assessment (HIA) of NDMA in metformin showed that the drug is likely to cause cancer in about 0.21 people out of 100,000.
Despite the low cancer risk, the agency said that it would be halting the manufacturing and sales of the diabetes drugs temporarily and will be restricting prescriptions for the time being.
NDMA was detected in metformin products from Daewoong Pharmaceutical, Hanmi Pharmaceutical, Yuhan, JW Pharmaceutical, Hanall Biopharma, Shinpoong Pharmaceutical, and Jeil Pharm, among others.
“Because we detected unacceptable levels of NDMA in several manufactured metformin products, we believe that NDMA detection is due to the manufacturing process of the product as only some products exceeded the acceptable standard of NDMA, “a spokesperson for the agency said.
Concerns about NDMA in metformin arose last year, leading to the U.S. Food and Drug Administration (FDA), the European Medicine Association (EMA), the MFDS, and various health regulators around the globe to conduct NDMA tests on metformin products on the market.
The Korean Diabetes Association (KDA) also warned last year that about 2.4 million people take metformin to treat type 2 diabetes and no alternatives exist for the drug, calling for immediate investigation.
Metformin is recommended as the first-line therapy for type 2 diabetes worldwide.
The MFDS’s recent announcement is the result of a year-long investigation into NDMA in metformin. The agency had previously announced measures to manage carcinogen risk in medical products, requiring local pharmaceutical firms to launch investigations into all products for possible impurities.