The Ministry of Food and Drug Safety said that it has failed to find the traces of potentially cancer-causing chemical N-Nitrosodimethylamine (NDMA) in the locally collected and inspected batch of GSK’s Zantac.
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NDMA is an impurity defined by the WHO’s International Cancer Research Institute (IARC) as a potentially carcinogenic substance to humans.
The ministry inspected the drug after the U.S. Food and Drug Administration announced that it had found NDMA in the ranitidine-class medications, including Zantac, last Friday.
Among the ranitidine products that the FDA detected traces of NDMA, the Korean health authority collected and examined 29 products of three Zantac items -- Zantac 75mg, Zantac 150mg, and Zantac Inj. 2 ml -- manufactured by GSK Korea plus six batches of ranitidine used as the raw material for Zantac.
Ranitidine, known for popular drug Zantac, is effective in peptic ulcer disease, gastroesophageal reflux disease, and gastritis.
The ministry believes that NDMA detected in Zantac may have been identified under different circumstances from valsartan-containing hypertension treatment incident.
“While valsartan generated NDMA during the manufacturing process, we believe that the NDMA-detected Zantac was not produced during the manufacturing process here,” the ministry said. “Although the recent test did not detect NDMA, the ministry will continue to expand the collection and testing of all locally manufactured ranitidine raw materials from 11 manufacturers and 395 pharmaceutical products using the raw materials.”
The ministry will work closely with regulatory agencies in the U.S. and EU by sharing NDMA detection information and identifying the cause of NDMA detection among ranitidine products, the ministry added.
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