Tuesday, 16 October, 2018

Some drugs containing valsartan recalled due to potential carcinogen

The recall is on medication containing valsartan which is used to treat high blood pressure.					Courtesy of Hope Litoff The recall is on medication containing valsartan which is used to treat high blood pressure. Courtesy of Hope Litoff
Anna Jefferson | 13 July, 2018, 15:00

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 Medicines and Healthcare products Regulatory Agency (MHRA) issued a recall yesterday (July 10) of all batches of valsartan/hydrochlorothiazide 160/12.5mg film-coated tablets - used to treat high blood pressure and heart conditions - made by Accord Healthcare.

The European Medicines Agency (EMA) said that it is reviewing medicines containing the active substance valsartan that is supplied by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China. The recall was issued by the manufacturers of several drugs involving five companies.

Additionally, precautionary measures will be taken by the EMA, which will review other valsartan medicines to ensure they have not also been affected.

You should not stop taking your valsartan medicine unless you have been told to do so by your doctor or pharmacist. The 219 drugs containing Chinese-made Valsartan are among 571 available drugs in Korea that contain the ingredient coming from other countries.

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Over 484,682 kilograms of Valsartan have been imported to Korea over the last three years, according to the ministry, but only 2.8 percent, or 13,770 kilograms, contain ingredients from China.

"An impurity, N-nitrosodimethylamine (NDMA), was found in the valsartan used in these products", Health Canada said in a news release on Monday. After its announcement on Saturday, the ministry launched on-site investigations of 82 pharmaceutical companies to check whether the drugs contain NDMA.

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".

The Ministry has affirmed that it is always in close coordination and communication with the FDA and the European and Australian Medicines agencies to get any updates and take any necessary actions as soon as possible to protect the health of patients and people in the country.

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