Ranitidine products banned due to potential carcinogen

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Ranitidine products banned due to potential carcinogen

The Ministry of Food and Drug Safety has banned the import, manufacture and sale of 269 ranitidine products due to the presence of a material that might cause cancer.

The ministry announced in a statement Thursday that the products, including GlaxoSmithKline's Zantac, were found to contain N- nitrosodimethlyamine (NDMA), a toxic organic chemical often a byproduct of industrial processes.

The measure follows the U.S. Food and Drug Administration's determination earlier this month that some ranitidine products sold in the United States were found to contain NDMA. The U.S. regulator did not order a sales suspension as it found only small amounts of the substance in the products.

The Korean regulator initiated its own investigation shortly after the U.S. FDA announcement to determine whether ranitidine products sold in Korea contain NDMA.

NDMA is designated as a possible carcinogen by the World Health Organization.

With the announcement in Korea, all 269 medicines containing any of seven types of ranitidine are now banned from being prescribed.

The seven ranitidine materials were found to contain up to 53.5 parts per million of NDMA, significantly higher than 0.16 parts per million limit set by the ministry. The drug safety ministry suspects NDMA was inadvertently introduced as a result of nitrite and dimethylamine deteriorating over time or dimethylamine being mistakenly added during the manufacturing process.

The Korean Medical Association sent an urgent message to its members Monday instructing them to cease prescribing ranitidine products and offer the patients substitute medicines free of the dangerous substance.

The ministry said the danger is low for those who have consumed the ranitidine products in minimal quantities. At the moment, more than 1.4 million people are taking the medicine, many for gastrointestinal diseases, and most of them consume the drug for less than six weeks per year.

The Korean drug authority plans to further investigate the potential health effects of NDMA to determine the long-term effects of consuming ranitidine products. It also advised patients to visit local hospitals and clinics for check-ups.

BY KO JUN-TAE [ko.juntae@joongang.co.kr]
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