The Ministry of Food and Drug Safety banned the import and sale of 115 hypertension drugs out of fear that they might contain carcinogenic ingredients. The circular has also directed that all healthcare practitioners and doctors should not prescribe or dispense the affected products and also advises patients to not discontinue use of the medicine unless they consult with the doctor to prescribe other alternatives registered with the Ministry.
N-nitrosodimethylamine (NDMA) has been detected in the valsartan active substancemanufactured by Zhejiang Huahai Pharmaceuticals.
As a precautionary measure, the valsartan-containing medications are recalled on a pharmacy level.
Meanwhile, MOHAP also explained that other medicines containing Valsartan, which are manufactured using the same active ingredient from other sources, are intact and unaffected-meaning that these are still safe to use.
"Despite the lack of conclusive evidence on whether NDMA is present in these products or whether they are truly unsafe, these measures were undertaken to pre-emptively protect consumers", a spokesman for the Ministry of Food and Drug Safety said on Saturday.
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A substance in valsartan than is found in some heart and high blood pressure drugs has been linked to cancer.
However, not all Valsartan contains the carcinogen, only that made in China, the drug ministry noted.
As it is now off-patent, it is used as ingredient in many other generic medicines. Of 484,682 kilograms of Valsartan imported over the last three years, only 13,770 kilograms, or 2.8 percent contain ingredients from China.
Oh Beom-jo, a professor of family medicine at Dongguk University Medical Center, said, "Patients will be confused about whether their drugs are problematic or not".
Health Canada indicated it is monitoring the companies' recalls and suggests people taking medicine with valsartan should keep doing so unless their doctor or pharmacist tells them to stop.
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