The government is likely to announce the results of the test on ranitidine heartburn drugs to see if they contained a carcinogen, N-Nitrosodimethylamine (NDMA), within a week or two.
The Ministry of Food and Drug Safety is testing locally manufactured ranitidine raw materials for NDMA.
Ministry officials said the testing was at the last stage and they could reveal the outcome this week, at the earliest.
The U.S. Food and Drug Administration said on Sept. 13 that it detected low levels NDMA in popular heartburn treatment Zantac.
After learning the news, the Korean regulator first collected 29 products that had the same manufacturing number with GSK’s three Zantac products and six ranitidine raw materials for inspection. The food and drug safety ministry found no NDMA in the 35 products.
However, the ministry expanded the collection and testing of all locally manufactured ranitidine raw materials from 11 manufacturers and 395 pharmaceutical products using raw materials.
NDMA is a carcinogen that had been found in hypertension treatments that contained valsartan manufactured by China’s Zhejiang Huahai last year. The government banned the sale of Chinese-made valsartan and recalled all of the related products. Depending on the levels of NDMA in the ministry’s testing, the government could take the same measure this time.
Pharmaceutical companies are paying keen attention to the ministry’s slightest move.
After an official at the food and drug safety visited the Ministry of Health and Welfare and Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) on Tuesday, rumors spread that the ministry would announce the ranitidine testing results on Wednesday morning and hold a briefing to pharmaceutical industry officials at the KPBMA office in the afternoon. Industry officials received the notice of the briefing from KPBMA.
However, rumors were not true.
“It is true that the ministry official visited the health ministry and KPBMA. But it was for collaborative work to prepare for the worst-case scenario, not because the ministry had the results of the testing,” another official at the food and drug safety ministry said. “There will be no announcement of the ranitidine inspection results until Wednesday.”
As the ministry said it would reveal the outcome within two weeks at the earliest, it will likely announce the results as soon as it gets them. The testing is at the last stage, and the ministry may disclose the outcome within this week, observers said.