China-made medicines with Valsartan to be withdrawn

Friday, 13 Jul, 2018

Several drugs used to treat high blood pressure and help prevent heart attacks and strokes have been recalled by Health Canada.

But the agency also said that anyone taking medication that contains valsartan should continue to take it unless told to stop by their doctor or pharmacist. They are also used by patients who have had heart failure or a recent heart attack.

Mina Tadrous, (pharmacy faculty, University of Toronto), explained that valsartan is a common drug used by people with high blood pressure.

N-nitrosodimethylamine (NDMA) has been detected in the valsartan active substancemanufactured by Zhejiang Huahai Pharmaceuticals. For example, Swiss company Novartis informed the ministry that their products containing valsartan are not impacted because these products do not contain the ingredient from external suppliers.

The alert comes after the watchdog issued a recall last week (July 6) for seven batches of valsartan-containing medicines made by Accord Healthcare and Dexcel Pharma Ltd, after an impurity was identified in their manufacturing process which "may have carcinogenic potential". "Patients should contact their pharmacist (s) to see if the drugs they're taking are indeed the affected, recalled valsartan products".

"Out of the 2,690 hypertension drugs that are licensed for sale domestically, 571 of them contain Valsartan", said Kim Yu-mi, head of the Drug Review and Management Division at the ministry, "and 219 out of these contain Chinese-made Valsartan, but if we conduct a review of available data and on-site investigations, we may discover that the problematic drugs are fewer than this number".

On Saturday, the Health Insurance Review & Assessment Service revised its Drug Utilization Review, a computerized pharmaceutical review system that oversees prescriptions, to display an on-screen warning when doctors try to prescribe a banned drug on their computers.

According to Health Canada recommendations, patients that take that drug should talk with their pharmacists to know if their medicine was recalled.