All oral ranitidine products will be pulled from NH wardstock areas due to the ranitidine oral product recall and alternative products will need to be prescribed until further notice. At this time, injectable ranitidine has not been affected. Famotidine and cimetidine are in very limited supply nationally so other alternatives will need to be considered as supply of either agent can not be guaranteed on a long-term basis. Kindly consider de-escalation of therapy for all current patients receiving oral ranitidine before escalating to PPI therapy.
The Issue:
Health Canada recently placed a "do not distribute" hold on all new manufacturing of ranitidine in Canada based on global signals of an impurity, NDMA. NDMA is classified as a probable human carcinogen meaning long-term exposure to levels above those considered safe may increase the risk of cancer. It should be noted that NDMA is an environmental contaminant present in low levels in every day life, such as in drinking water, and long-term exposure to these low levels is not expected to cause harm.
Sandoz has voluntarily recalled their oral ranitidine tablets as they did not pass the acceptable level of NDMA in their product. Health Canada has also extended the recall to Apotex, Sanis, Pro-Doc, and some lots of Sivem. The oral suspension is also affected by the recall. Health Canada will provide further information for other vendors as testing results become available.
Practice Implications:
Since NH primarily carries the Apotex brand, we will be changing over all patients currently receiving oral ranitidine (suspension and tablets) and provide alternatives to current and new patients as listed below. There will be no change to the injectable product as verbal communication from the manufacturer indicates this product is not affected at this time. Clinicians are asked to assess patient suitability for de-escalation of therapy (e.g. antacids) before increasing therapy to proton-pump inhibitors (PPIs). Non-medication interventions should also be considered (e.g avoid dietary triggers, elevate head of bed). Further, the therapeutic interchange for non-formulary H2-receptor antagonists to ranitidine will be on hold until further notice.
Further information and practice implications
For further information contact:
NH Medication Use Management Pharmacists:
Jessica Brecknock (250-267-5940)
Ryan Doerksen (250-565-5956)
mumpharmacist@northernhealth.ca