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As the possibility of acting as a carcinogen in the Chinese "Valsartan", used as a treatment for hypertension, was discontinued for 219 hypertension treatments using raw materials.
NDA is recalled as an impurity of N-nitrosodimethylamine (NDMA) in valsartan of China, which is used as an antihypertensive drug.
N-Nitrosodimethylamine has the potential to act as a carcinogen in humans at the International Cancer Institute of the WHO (IARC). Which is clbadified as "2A".
In addition, 829 companies are allowed to use valsartan as a raw material.
Also, stop selling. The total production and import of valsartan for the last three years is 486,482 kilograms (368,169 kilograms of 116,513 kilograms manufactured and imported), and the Chinese manufacturer Valsartan is equivalent to 2.8 percent (13,770 kilograms) [19659002] The KFDA said: "Currently, we are conducting investigations on copper impurities (cause, timing, etc.) and will take necessary measures such as collection and disposal quickly according to the results of the investigation."
The level of NDMA detection and risk of the product has not been confirmed, but it has been done for the protection of the consumer. Previously, the European Medicines Agency (EMA) was investigating the detection of N-nitroso dimethylamine in China and its effects on patients who took it, and announced that it was being recalled as a measure precautionary.
All medicines in this category are special medicines that can be taken after prescription by the pharmacy according to the doctor's prescription. The "no prescription" warning is registered in the system Drug Safety Service (DUR).
The KFDA urged patients taking the drug to consult to consult their doctor promptly, without stopping taking it at random.
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