The drug regulator said it has suspended the manufacturing, sale, and prescription of 13 nizatidine-containing stomach medicines, after detecting an excessive level of N-Nitrosodimethylamine (NDMA), a potentially carcinogenic substance. The 13 drugs include Alvogen Korea’s Zanitidine.
The Ministry of Food and Drug Safety said it collected 93 nizatidine medications and found the excessive levels of NDMA in 13 products, which led to the latest ban.
Following an industry-wide recall of ranitidine-containing drugs due to NDMA contagion, the ministry collected entire drugs that contained nizatidine, which is chemically similar to ranitidine and tested them for any harmful substance.
The results showed that among 93 nizatidine products using particular manufacturing numbers, 13 had a slightly exceeding level of NDMA, compared to the authorities’ criteria of 0.32 ppm.
“We presume that the NDMA was detected because microorganisms of nitrite group and dimethylamine group, contained in nizatidine, seemed to have decomposed and combined over time, or nitrites were unintentionally mixed in the drugs during the manufacturing process,” the food and drug safety ministry said. “The ministry will analyze the cause of the NDMA detection in nizatidine drugs in detail through the “Committee for Investigation on the Cause of NDMA in Ranitidine, an expert group.”
According to data from the Health Insurance Review and Assessment Service, nizatidine was prescribed for gastritis and duodenitis the most in 2017, and 75 percent of patients were presumed to have taken nizatidine for less than two weeks, the ministry said.
A short-term nizatidine medication does not pose a high risk for humans, it added.
The government’s latest ban was to take preemptive and preventive measures after conducting tests on all commercially available nizatidine ingredients and finished drugs, the ministry noted.
The food and drug safety ministry plans to share the testing results with foreign regulatory institutions.
The Ministry of Health and Welfare also ordered hospitals, clinics and pharmacies to stop prescribe and dispense the suspended medicines.
Patients who were prescribed with any of the 13 suspended medicines can visit the hospital or clinic to consult whether they would take ulcer drugs additionally, and can get an additional prescription. For once only, the patient will not have to pay for the cost of the additional prescription.
The 13 suspended drugs are Niza X Tab 150mg. by White Life Science, Nizant Cap. by A Progen Pharma, Nizixid Cap. 150mg by Daewoo Pharmaceutical, Celzatin Tab. by Telcon RF Pharmaceutical, Wezatidine Tab. 150mg by Wooridul Pharm, Zanitidine Tab. 75mg by Alvogen Korea, Zanitin Tab., Zanitin Tab. 150mg, and Zanitin Cap. 150mg by Kyungdong Pharma, Tinza Tab. and Tinza Tab. 150mg by Chem Tech Research Incorporation, Protine Tab. by Binex, and Huzatine Tab. 150mg by Huvist Pharm.