Korean drug safety authority reviewing metformin

The Korean drug safety authority said Monday that it is directly reviewing products containing metformin, the Type 2 diabetes treatment whose commercialized variants in Singapore have been tested to contain an unacceptable level of a cancer-causing impurity.

This impurity, called N-nitrosodimethylamine, or NDMA, was found in three out of 46 metformin finished products sold in Singapore. Singapore’s Health Sciences Authority recalled the products.

Ministry of Food and Drug Safety (Yonhap)

Metformin is widely used to treat Type 2 diabetes patients, and as a first-in-class drug it has no known substitute.

Korea’s Ministry of Food and Drug Safety said none of the three recalled products had been sold in Korea. The MFDS said that it is carrying out tests of over 640 metformin drugs in Korea as precautionary measure.

Patients are not advised to halt the medication on their own without doctor’s consultation, the MFDS cautioned. 

By Lim Jeong-yeo (kaylalim@heraldcorp.com)