Health Canada continues investigation as more heartburn medications recalled

The bottling line at Apotex's North York packaging operations is photographed on March 29 2018. (Fred Lum/The Globe and Mail)

Health Canada has recalled another group of ranitidine medications — commonly used to treat ulcers, heartburn and acid indigestion — over an impurity that has been linked to an increased risk of cancer.

Dominion Pharmacal, Laboratoire Riva Inc., Pharmascience Inc. and Vita Health Products Inc. are the latest drug manufacturers to have recalled all lots of their prescription over-the-counter ranitidine products, according to Health Canada.

The agency says the medications are being recalled “as a precautionary measure.”

In September, Health Canada requested that companies stop distributing ranitidine drugs in Canada while it assesses a possible impurity known as N-nitrosodimethylamine (NDMA).

According to Health Canada, NDMA is classified as a “probable human carcinogen,” which means long-term exposure to levels above what is considered safe could increase the risk of cancer.

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Health Canada said halting distribution was an “interim, precautionary measure” as the agency continued to “gather information from companies and to assess the issue with other international regulators.”

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However, after issuing the request, drug manufacturers Apotex Inc, Pro Doc Limitée, Sanis Health Inc. and Sivem Pharmaceuticals ULC announced recalls.

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And, earlier this month, French drugmaker Sanofi SA announced it was recalling the widely popular heartburn medication Zantac, which has been sold over the counter in Canada and the U.S. since 2017.

“We don’t believe there’s a risk,” Sanofi CEO Paul Hudson told a press conference in Framingham, Mass., earlier this month. “But we have to – and are appropriately duty-bound to – satisfy the regulators, which we will do, and we’ll move on from there.”

Now, a total of 27 ranitidine products have been recalled. A full list can be found on Health Canada’s website.

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According to Health Canada, those who are taking a ranitidine drug should talk to their doctor or pharmacist at their earliest convenience about alternative treatment options.

“There are many prescription and over-the-counter drug alternatives in Canada that are authorized for the same or similar uses as ranitidine,” the Health Canada website says.

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The agency says individuals taking a prescription ranitidine drug, including any of the recalled products, should not stop taking it unless they have spoken to their health care provider and have obtained an alternative treatment, as the risk of not treating their condition “may be greater than the risk related to NDMA exposure.”

—With files from Reuters


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