The Ministry of Food and Drug Safety has suspended the manufacturing and selling of 269 ranitidine-using medicines for heartburn, after detecting a carcinogen, N-Nitrosodimethylamine (NDMA).
NDMA is an impurity designated by the World Health Organization's International Cancer Research Institute (IARC) as a potentially carcinogenic substance to humans, categorized in Group 2A. Last year, NDMA had been found in hypertension treatments that contained valsartan.
In a briefing in Seoul on Thursday, the ministry said NDMA levels exceeded the provisional standard in seven ranitidine raw materials. As 269 products contained the risky raw materials, the government said it would ban the manufacturing, importing, and selling of the ranitidine medicines.
The government suspended the prescription of the 269 drugs from 1 a.m. on Thursday, as well as their reimbursement. A total of 1,443,064 patients are taking ranitidine. The ministry said it would provide drug distribution information for pharmaceutical companies so that they can recall the medicines smoothly. It will also give drug supply information to wholesalers, medical institutions, and pharmacies.
According to the food and drug safety ministry, seven ranitidine raw materials had NDMA levels reaching as high as 53.50 ppm, significantly exceeding the provisional standard of 0.16 ppm. The ministry calculated the provisional standard assuming a patient takes ranitidine’s maximum daily dose of 600 mg for a lifetime.
The ministry presumed that NDMA was generated as nitrites and dimethylamine in ranitidine were decomposing and combining themselves over time, or nitrites were unintentionally mixed in the manufacturing process.
The ministry plans to establish an investigative body and a human impact assessment committee to identify the cause more accurately.
To respond more quickly and efficiently to drug accidents in the future, the ministry plans to form and operate a council where relevant ministries, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korean Medical Association, Korean Hospital Association, and Korean Pharmaceutical Association participate.
The council will discuss various measures, including a deduction system for drug safety, a relief fund, and liability insurance.
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