TAIPEI – March 16, 2021 – According to an online news report posted on focustaiwan.tw, announces another metformin drug has been recalled due to carcinogen concerns. The nation of Taiwan’s Food and Drug Administration (FDA) states that Kotang X.R. 500mg tablets, a popular diabetes medication prescribed in Taiwan, is currently under recall because the medication could contain a carcinogenic ingredient.
The news report states that the drug’s manufacturer, Shou Chan Industrial, announced the recall of 16 million Kotang X.R. 500mg tablets. Kotang X.R. 500mg tablets are a metformin-based medication. The medication is a first-line medication for the treatment of Type-2 Diabetes, according to the FDA. The manufacturer stated that it initiated the recall as part of a “risk control” strategy, and the manufacturer did not provide any further details about the recall.
Kotang is the fifth metformin-based diabetes drug to be recalled by a manufacturer due to N-nitrosodimethylamine (NDMA) contamination fears. N-nitrosodimethylamine (NDMA) is a carcinogenic compound that has been discovered in many different medications that treat blood pressure, stomach, and diabetes medical conditions.
For nearly one year, the U.S. Food and Drug Administration and other global health agencies have demanded that drug manufacturers producing metformin around the world examine their products on a batch-by-batch basis to detect possible NDMA contamination.
According to Taiwan’s FDA, many metformin drug manufacturers in Taiwan have either recalled or suspended manufacturing of their metformin products and are working to meet the FDA’s criteria for controlling NDMA contamination in their products.
The head of Taiwan’s Medicinal Products Division of the FDA, Hung Kuo-teng, stated that the demand for Kotang X.R. tablets is approximately 5 million tablets a year in Taiwan. Metformin is covered by its national health insurance system, which purchases about 1 billion metformin tablets in Taiwan annually. Mr. Kuo-teng warned patients who are prescribed the medication not to discontinue taking the medication without first speaking with their doctors. A sudden stop in metformin use is dangerous because this can cause patients to suffer acute and even fatal medical complications due to a lack of blood sugar control.
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