On Wednesday morning, Health Canada announced that an additional four companies were recalling the heartburn drug ranitidine, known more commonly as its brand-name Zantac. Several variations of the drug are being recalled as they are suspected to contain the impurity N-nitrosodimethylamine, which has the potential to cause cancer in humans.
Earlier this month, Health Canada announced that a substance that could cause cancer was detected in some ranitidine heartburn medicines, including in the brand-name drug Zantac. This report has since been updated to include an additional four companies that are recalling similar heartburn drugs, due to the same potential impurity.
The current companies that are recalling their heartburn drugs include Apotex Inc, Pro Doc Limitee, Sanis Health Inc, and Sivem Pharmaceuticals ULC. This is in addition to the Novartis AG’s recall, which was announced on September 13.
According to Health Canada, the medications being recalled may have been made using an active ingredient containing the impurity N-nitrosodimethylamine (NDMA), and therefore may contain above-accepted levels of NDMA.
Additional #ranitidine drugs recalled as Health Canada investigates an impurity, #NDMA, found in some of these drug… https://t.co/dtKog4Ipme— Health Canada and PHAC (@Health Canada and PHAC) 1569448821.0
The Health Canada report explains, “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.”
It goes on to add, “We are all exposed to low levels of NDMA in some foods (such as meats, dairy products and vegetables) and in drinking water. NDMA is not expected to cause harm when ingested at very low levels.”
The recalled heartburn drugs are expected to exceed these safe "low" levels.
Health Canada is assessing the issue of an impurity, #NDMA, found in some #ranitidine drugs (used to reduce stomach… https://t.co/Gjt9vh2jTw— Health Canada and PHAC (@Health Canada and PHAC) 1568415004.0
If you have any of the affected or recalled heartburn drugs at home, Health Canada explains that there are several prescription and over-the-counter drug alternatives in Canada that are authorized for the same or similar uses as ranitidine.
For those who are interested in seeking alternative treatment options, Health Canada recommends speaking to a doctor or pharmacist.
Their report makes it clear that individuals taking a prescription ranitidine drug should not stop taking it unless they have spoken to their health care provider, as the risk of not treating the condition may be greater than the risk related to NDMA exposure.
[1/2] As a precaution, Health Canada has asked companies to stop distributing #ranitidine drugs in Canada (e.g., Za… https://t.co/rJTPbbR7RP— Health Canada and PHAC (@Health Canada and PHAC) 1568813150.0
For a full and detailed list of the recalled heartburn drugs in Canada, you can visit Health Canada’s website by clicking 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.
Health Canada states, “The Department will take action as needed, and will keep Canadians informed.”