The Ministry of Food and Drug Safety announced on Thursday the suspension of sales of 269 ranitidine-based drugs on the market including Zantac and Curan Tab, after it found that the medicines contain N-nitrosodimethylamine (NDMA), a possible human carcinogen, exceeding the acceptable level of 0.16 ppm. The ministry kicked off its own investigation following the U.S. Food and Drug Administration’s statement released on Sept. 14 about the low-level presence of NDMA in ranitidine. Seoul’s regulator has found that all seven ranitidine medicines showed NDMA levels, ranging from zero to 53.5ppm depending on the manufacturer’s serial numbers.
NDMA, classified as a Group 2A probable carcinogen by the International Agency for Research on Cancer, is also easily found in our daily lives including cigarette smoke or foods. It is unlikely for patients who have taken the medicines for a short period of time to develop cancer, and they are so commonly used to treat stomach diseases like reflux esophagitis and stomach ulcers to an extent that some 1.44 million patients in the country are estimated to take the medicines. Those who have chronic diseases often take the medicines with prescriptions to prevent gastritis. Given that Zantac, one of the ranitidine products, has been on the market for over 36 years, consumers may get worried over its effect on their health. The authority said it will form a committee to assess potential effects of ranitidine on patients. They should speed up the process of their investigation to dispel the public’s fear.
Out of the seven ranitidine materials with NDMA found, one was produced in the country while six were imported from countries like India and Spain. As the country relies on the internal safety verification of a local manufacturer for foreign-made raw material medicines, the authority often goes unaware of a change in the manufacturing process or a problem in the products. Therefore, the drug ministry should strengthen its proactive management of raw material medicines, not just following suit of foreign agencies.
As we have seen in the valsartan recall last year and the latest ranitidine scandal, a drug ministry lacking in expertise would directly lead to the losses of our health and the pharmaceutical industry.