Health Canada assessing NDMA in ranitidine
- Starting date:
- September 13, 2019
- Posting date:
- September 13, 2019
- Type of communication:
- Information Update
- Source of recall:
- Health Canada
- Important Safety Information
- General Public
- Identification number:
For Immediate Release
OTTAWA – Health Canada is informing Canadians that it is aware that the impurity N-nitrosodimethylamine (NDMA) has been detected in some ranitidine drugs. Health Canada is closely assessing the issue in collaboration with other regulators internationally, including the U.S. Food and Drug Administration and the European Medicines Agency. The Department will take action as needed, and will keep Canadians informed.
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. 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.
Ranitidine is available in Canada over-the-counter (for example, under the brand name Zantac and as generics) and by prescription (as generics). Over-the-counter ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. Prescription ranitidine drugs are used to reduce stomach acid for the treatment and prevention of various conditions, such as heartburn, ulcers of the stomach and intestines, and gastroesophageal reflux disease (commonly known as GERD).
Health Canada’s first priority is to help protect the health and safety of Canadians. 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. 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.
There are many prescription and over-the-counter drug alternatives in Canada that are authorized for the same or similar uses as ranitidine. Individuals wishing to seek other treatment options should speak to their doctor or pharmacist. Individuals taking a prescription ranitidine drug should not stop taking it unless they have spoken to their health care provider and obtained alternative treatment, as the risk of not treating the condition may be greater than the risk related to NDMA exposure.
Health Canada has been actively working to address the issue of NDMA and similar impurities, known as nitrosamines, found in certain “sartan” angiotensin receptor blocker (ARB) blood pressure medications since 2018. Health Canada continues to work closely with international regulatory partners to address the issue. This includes broadening its efforts to evaluate the potential for nitrosamines in drugs other than sartans and measures to address and prevent the impurities.