UPDATE : Monday, September 7, 2020
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Myungmoon Pharm’s valsartan additionally suspended
  • By Lee Hye-seon
  • Published 2018.08.23 15:10
  • Updated 2018.08.23 15:10
  • comments 0

The government said it has completed testing all valsartan-using hypertension drugs, following the recall of Chinese-made valsartan treatments due to a carcinogen risk.

The Ministry of Food and Drug Safety found that Myungmoon Pharm’s Valsanin Tab. 80 mg had N-Nitrosodimethylamine (NDMA) which exceeded the acceptable level of 0.33 ppm in additional testing of 45 valsartan drugs. On Aug. 6, the ministry announced interim results of examinations on 41 products.

The government banned the sales and prescriptions of Myungmoon’s valsartan, which had 0.4 ppm NDMA. China’s Jiangsu Zhongbang manufactured the drug's raw materials.

The ministry said 4,048 patients were taking Myungmoon’s Valsanin as of Thursday. The government has suspended the prescription and dispensing of the tablet via the Drug Utilization Review (DUR) system of the Health Insurance Review and Assessment Service (HIRA). The authorities also discontinued the insurance coverage for Valsanin.

Patients who took the drug should regain the medicine through re-prescription or re-dispensing at the same hospital or pharmacy, not to make the copayment more than once.

Physicians and pharmacists can replace the treatment with other valsartan-using medicines or other ingredient-using hypertension drugs.

“Patients who are taking the banned drug should not discontinue the medication arbitrarily but receive re-prescriptions through medical consultations at the hospital or pharmacy where they obtained the drug,” the ministry said.

Pharmswell’s medicine that used the ingredient made by Spanish firm Quimica Sintetica also had an excessive level of NDMA. However, the government did not take any measure because the drug has been already suspended on July 7.

Accordingly, patients can continue to take the valsartan-using drugs unless they were suspended or banned from prescription by the authorities.

lhs@docdocdoc.co.kr

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