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.
The news comes just weeks after Health Canada announced yet another recall of Zantac products after NDMA was found at unacceptable levels.
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.
On June 26, the EMA suspended the sale of all Zantac products in the European Union due to the presence of NDMA and the health concerns the impurity posed to consumers.
But, Health Canada continued to allow the sale of Zantac as long as manufacturers conducted testing for NDMA and recalled any products that exceeded acceptable limits.
“The Department is gathering and sharing information with other regulators internationally and with Canadian companies to better understand the issue and whether there may be a risk to Canadians,” the agency said. “This includes conducting its own tests and assessing whether the results seen in laboratory tests present a human health risk. The Department will take action if a risk to Canadians is identified, and will continue to inform the public of new safety information.”