The Ministry of Food and Drug Safety said it might test all stomach medicines in the same class as ranitidine to check if they have an excessive level of N-Nitrosodimethylamine (NDMA), a potentially cancer-causing substance.
“We are reviewing local and overseas materials whether to test ‘tidine-family’ drugs, besides ranitidine,” a ministry official told reporters on Tuesday.
When the regulator detected excessive levels of NDMA in valsartan-containing hypertension drugs last year, it also tested other products in the same class as valsartan and set the preliminary criteria for NDMA levels.
The ministry plans to conduct NDMA testing on ranitidine-using finished drugs to tighten monitoring on harmful chemicals.
Just as the ministry had disclosed the method of NMDA analysis on drugs in the same class as valsartan after the valsartan recall, it will do the same on ranitidine raw materials on the ministry’s homepage after receiving advice from the Central Pharmaceutical Affairs Advisory Committee.
In response to the pharmaceutical industry’s protest that the measure was excessive, the ministry said, “This is not an excessive response because we took the same measure that we used during the valsartan recall.”
The ministry will also draw up a plan to reduce the chance that it could miss screening out drugs with excessive levels of NDMA.
“We will conduct a study on unexpected medicines, such as ranitidine, that could contain impurities including NDMA,” the ministry official said.
The ministry will select and inspect most-likely raw materials first to prevent any carcinogen risk, he added.
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