Diabetes drugs found to contain cancer-causing contaminant

The Ministry of Food and Drug Safety (MFDS) suspended sales of 31 diabetes drugs containing metformin on Tuesday found to contain high levels of a cancer-causing contaminant known as N-nitrosodimethylamine (NDMA).

The 31 drugs, all of them made by local pharmaceutical companies, contain concerning levels of the potential carcinogen, although they would not pose an immediate health risk, according to the regulator.

The agency launched an investigation last December after several countries around the world recalled three metformin-based drugs found to contain NDMA.

The ministry tested 34 imported and 254 locally marketed metformin medicine used for diabetes treatment. Of the 254 home-grown products, 31 are found to contain higher NDMA levels than the internationally accepted standard.

Metformin is a medication that helps control high blood sugar in people with type 2 diabetes.

NDMA may increase the risk of cancer if people are exposed to higher than acceptable levels over long periods of time, according to the MFDS.

NDMA is a chemical found in both industrial and natural processes, and low levels of it aren’t dangerous, the ministry said.

The regulator recommended diabetes patients taking the recalled products consult with their doctor before doing anything, rather than immediately stopping taking the pills.

The recalled drugs include Guardmet Tab from JW Pharmaceutical, Grimefol SR Tab by Hanmi Pharmaceutical, Glucodaun OR Tab from HanAll BioPharma and Lipimet SR Tab from Daewoong Pharmaceutical.

European Union and U.S. health authorities have started their own investigations into the diabetes drugs sold in their region.

The U.S. Food and Drug Administration found “not detectable to low levels” of NDMA in FDA-approved metformin from the latest investigation, according to a press release.

The health care authorities also recalled the widely popular heartburn drug Zantac last year due to the presence of the carcinogen.

The European Medicines Agency also ordered European pharmaceutical companies to test if metformin in the diabetes drugs have unsafe levels of NDMA.

BY PARK EUN-JEE [park.eunjee@joongang.co.kr]