Back in September, multiple heartburn medications were recalled from the market in Canada, after they were suspected to contain above acceptable levels of the impurity "N-nitrosodimethylamine". Now, the heartburn drug recall in Canada has been expanded to include even more drugs, with some products suspected of having the potential to cause cancer in humans.
Earlier this year, Health Canada announced the country-wide recall of several ranitidine heartburn medications, known more commonly under the brand-name Zantac. This recall has now been updated to include an additional three companies and their heartburn drugs, all suspected of having the same potential impurity.
According to Health Canada's report, the recalled heartburn drugs could have been made using an active ingredient containing the impurity N-nitrosodimethylamine (NDMA), and may subsequently have above acceptable levels of it. In high doses, NDMA is suspected of having potential cancer-causing properties.
Previously, the companies that were recalling heartburn medication were Novartis AG, Apotex Inc, Pro Doc Limitee, Sanis Health Inc, and Sivem Pharmaceuticals ULC. This has now been updated to include additional products from Sanofi Consumer Health Inc., Sivem Pharmaceuticals ULC and Teva Canada Limited.
In an attempt to explain the risk, the Health Canada report states, “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.”
While the statement notes that Canadians are continually exposed to low levels of the NDMA impurity on a daily basis in meat, vegetables and drinking water, it explains that it is not dangerous when ingested at very low levels.
However, the report does confirm that the recalled heartburn drugs are expected to have NDMA levels that exceed these safe, low doses.
Several heartburn medication products, including Zantac, from the following companies have been recalled: Novartis AG, Apotex Inc, Pro Doc Limitee, Sanis Health Inc, and Sivem Pharmaceuticals ULC, Sanofi Consumer Health Inc., and Teva Canada Limited.
The full list of affected products can be found by clicking here.
For those in need of heartburn medications, Health Canada advises that there are several prescription and over-the-counter drug alternatives in Canada that are authorized for the same or similar uses as ranitidine. Those concerned should speak to a doctor or pharmacist.
Additionally, Health Canada urges any individuals taking prescription ranitidine drugs to continue taking their medication as usual, unless they have spoken with their doctor. The risk of not treating the condition may be greater than the risk related to NDMA exposure.
For the full and detailed list of the all recalled heartburn drugs in Canada, click here.
Global health regulators revealed earlier this month that they were reviewing the safety of ranitidine. Canada has since requested producers of the drug to halt distribution as it gathers more information.