OTTAWA, Sept. 13, 2018 /CNW/ - Health Canada is advising Canadians that a second impurity, called N-nitrosodiethylamine (NDEA)has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals in China.
All drugs containing valsartan manufactured by Zhejiang Huahai Pharmaceuticals have already been recalled in Canada
Health Canada advised Canadians about the recalls in July and August 2018. Health Canada also recently advised Canadians of its health risk assessment related to valsartan products containing NDMA.
The new information regarding NDEA is very limited at this time. Health Canada is assessing the issue and will update Canadians as more information becomes available, including whether the presence of NDEA impacts Health Canada's health risk assessment related to valsartan products containing NDMA.
Drugs containing valsartan are used to treat patients with high blood pressure to help prevent heart attacks and stroke. These drugs are also used in patients who have had heart failure or a recent heart attack.
Health Canada is working with the European Medicines Agency, the United States Food and Drug Administration, and other international regulatory partners to determine the root cause of the issue and confirm that necessary actions are taken to address the risk to health and prevent this situation from happening again. Health Canada will continue to keep Canadians informed as new information becomes available.
What you should doPeople taking valsartan drugs should check these lists of valsartan products that have and have NOT been recalled to see whether their medication is affected.
Patients taking affected valsartan medications should:
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SOURCE Health Canada
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