Health Canada announces that it is assessing the issue of an impurity called N-nitrosodimethylamine (NDMA) detected in some ranitidine drugs. Current evidence suggests that NDMA may be present in ranitidine, regardless of the manufacturer. As a result, and at Health Canada’s request, companies marketing ranitidine products in Canada have stopped any further distribution until evidence is provided to demonstrate that they do not contain NDMA above acceptable levels.
This is an interim, precautionary measure as Health Canada continues to gather information from companies and to assess the issue with other international regulators. The request to stop distribution means that the existing stock of ranitidine products currently available in pharmacies or at retail stores may continue to be sold. This is different from a recall, since products that are being recalled can no longer be sold.
One company, Sandoz Canada, is recalling its oral prescription products in Canada and other countries after testing identified levels of NDMA above what is considered acceptable if the drug were to be taken over a lifetime. The affected products are:
- Sandoz Ranitidine 150 mg (all lots)
- Sandoz Ranitidine 300 mg (all lots)
Should any additional recalls be deemed necessary, Health Canada will update and inform Canadians.
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 continues to gather and share information with other regulators, including the US Food and Drug Administration and the European Medicines Agency, 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.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../71029a-eng.php
In Hong Kong, Ranital Tab 150mg (HK-34755) is a Sandoz product containing ranitidine. This pharmaceutical product is registered by Novartis Pharmaceuticals (HK) Limited (Novartis). As confirmed with Novartis, the above product is not marketed in Hong Kong.
Currently, there are 67 registered pharmaceutical products containing ranitidine in Hong Kong. These products in the forms of oral preparations and injections are controlled as over-the-counter medicines and prescription-only medicines respectively. So far, DH has not received any case of adverse drug reaction related to ranitidine.
Related news on the detection of NDMA in ranitidine products was previously issued by European Medicines Agency, the US Food and Drug Administration, Health Canada and Singapore Health Sciences Authority, and was posted on the Drug Office website on 16 Sep 2019 and 17 Sep 2019. The DH has contacted the relevant overseas drug regulatory authorities for further information regarding the detection of NDMA in ranitidine products, and continues to remain vigilant on the update findings and investigation result announced by the authorities.
The DH has been contacting the certificate holder of all registered ranitidine products for follow up on the local impact of the issue. The DH keeps 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/Wednesday, Sep 18, 2019
Issued at HKT 17:00
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