Korea has temporarily suspended the manufacturing and selling of 31 drugs containing metformin after finding elevated levels of the probable human carcinogen NDMA, short for N-nitrosodimethylamine.
The Ministry of Food and Drug Safety conducted an inspection of 973 drug ingredients used for finished drug products produced at 12 different manufacturing sites; 34 imported drugs; and 254 domestic products; and found 31 of the domestic metformin products contained levels of NDMA above what drug regulators in Korea consider safe. Doctors were ordered to stop prescribing the medications.
“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 Minister said. The ministry began checking levels of NDMA in the first-line type 2 diabetes drug last year after an independent, online pharmacy alerted drug regulators in various countries including the U.S. that it had detected unsafe levels of NDMA in metformin. Health Canada issued the first recall of metformin products in February. The U.S. Food and Drug Administration (FDA) followed suit in June.
The same online pharmacy also detected concerning levels of NDMA in the commonly used heartburn drug Zantac and generics, which triggered sweeping recalls and, in April, resulted in the FDA pulling all Zantac products from the U.S. market.
Beasley Allen attorneys Frank Woodson and Lisa Courson are actively investigating potential claims involving regular Zantac/ranitidine use that may have led to cancer of the stomach, colon, intestines, kidneys or pancreas. If you or a loved one may have been affected, please contact us. Beasley Allen is not currently taking claims related to metformin.