其他安全警示

Canada: Health Canada assessing NDMA in ranitidine (English Only)

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 US 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.

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.

Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../70989a-eng.php

In Hong Kong, there are 67 registered pharmaceutical products containing ranitidine. These products in the forms of oral preparations and injections are controlled as over-the-counter medicines and prescription-only medicines respectively. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to ranitidine. The DH has contacted the relevant overseas drug regulatory authorities for further information regarding the detection of NDMA in ranitidine products. Their replies are pending. The DH is currently contacting the certificate holder of all registered ranitidine products for follow up on the local impact of the issue. The DH will remain vigilant on the development of the issue and any safety update of the drug issued by overseas drug regulatory authorities for consideration of any action deemed necessary. Patients who are taking ranitidine-containing products should not stop taking the medicines, but should seek advice from their healthcare professionals for proper arrangement, e.g. use of alternative medicines with similar uses.

Ends/Monday, Sep 16, 2019
Issued at HKT 18:00

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