Health Canada announced it was aware that the probable human carcinogen NDMA (N-nitrosodimethylamine) has been detected at unsafe levels in some Zantac (ranitidine) products, and the agency is closely assessing the issue with other drug regulators internationally, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). “The Department will take action as needed, and will keep Canadians informed,” the agency said in a news release.
On April 1, the FDA ordered the withdrawal of all Zantac products from U.S. shelves after reviewing studies that showed levels of NDMA could increase in the heartburn medication even under normal storage conditions, such as when it is exposed to higher temperatures or the longer amount of time it is from the manufacture date.
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