The Ministry of Health and Welfare yesterday said that it is launching an investigation into stomach medicine containing ranitidine, which is marketed under the trade name Zantac, after a tip-off from the US Food and Drug Administration and the European Medicines Agency that it might contain a carcinogenic substance.
The ministry had been advised that Zantac, which is manufactured by UK-based GlaxoSmithKline PLC, could contain traces of N-Nitrosodimethylamine (NDMA), which is a probable carcinogen.
The ministry plans to complete a laboratory analysis by Oct. 18, Food and Drug Administration medicine section deputy head Wu Ming-mei (吳明美) said.
A screen grab from the Food and Drug Administration website
The US and European regulators have not yet ordered the drug to be withdrawn, as the NDMA content is minute and could be lower than ordinary NDMA intake from eating food, the agency said.
The US and European regulators are also still conducting risk assessments, Wu said.
More than 21 Taiwanese firms are producing drugs that include ranitidine, she said.
Citing National Health Insurance Administration (NHI) data, Wu said that the program uses about 80 million items containing ranitidine each year.
The investigation is prioritizing the drugs containing ranitidine that comprise the largest percentage of NHI funding, she said.
The administration has ordered all firms that use ranitidine to conduct immediate laboratory tests on the drugs currently on the market, she said.
All manufacturers must tender their laboratory test results before Oct. 18, Wu said.
Drugs that do not contain NDMA would be approved for continued manufacture and sale, she said.
Sales of drugs that have traces of NDMA exceeding 0.3 parts per million would be halted immediately, she added.
People concerned about their prescription drugs should raise the issue with their doctor or pharmacist, she said.
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