South Korea has banned the production and sale of 31 metformin-based diabetes drugs for the presence of a carcinogenic substance, the country`s health authority said on Tuesday.
The Ministry of Food and Drug Safety said a total of 288 active pharmaceutical ingredients and finished dosage forms of metformin circulating in Korea were checked for the substance and 31 had above the permitted level of N-nitrosodimethylamine (NDMA), which is classified as a probably carcinogenic to humans by the World Health Organization (WHO) International Agency for Research on Cancer.
The ministry put a temporary ban on the manufacture and sale of the affected products and told doctors to restrict prescribing the drugs to patients.
Metformin, a standard drug used for the treatment of type 2 diabetes mellitus, helps control high blood sugar and is marketed under various brand names.
The ministry said, however, those drugs are very unlikely to pose serious health risks, adding the levels of NDMA impurity are extremely low, and its impact assessment showed people who took the drugs had an additional cancer risk of 0.21 person for 100,000, which is lower than international pharmaceutical product safety standards of every 1 out of 100,000 persons.
The ministry said people who are taking the affected medications at present should not suddenly stop using them without consulting their doctors because the danger of not adequately controlling diabetes is far higher.
By Minu Kim
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