Other safety alerts
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| Canada: New Safety Information: Interaction of Proton Pump Inhibitors (PPIs) with Methotrexate |
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Health Canada is informing Canadians and Canadian health care practitioners that the labelling for methotrexate and Proton Pump Inhibitors is being updated to include information on a potential interaction between these products. The new information will be in the "Warnings and Precautions" section of the methotrexate and the PPIs labelling.
Methotrexate is used in the treatment of cancer and autoimmune diseases and proton pump inhibitors are acid reducers used in the treatment of heartburn or acid indigestion.
The use of these two products at the same time by patients may increase the amount of methotrexate in the blood leading to side effects. The possible risks to health include kidney failure, low red blood cell count, inflammation of the digestive tract, irregular heartbeat, muscle pain, infections, and diarrhea.
While a definite association between PPI use and an increase in methotrexate has not been confirmed, there have been a number of studies suggesting a possible interaction between PPIs and methotrexate. The potential for an increased risk of methotrexate side effects is very likely, which is why Health Canada is informing Canadians and Canadian health care practitioners of this change in labelling.
Health Canada will continue to evaluate the scientific evidence as it emerges and take appropriate action as needed.
Patients should not stop taking their medication unless they have been advised to do so by their health care professional. Patients using PPIs and methotrexate should consult with their doctor if they have any concerns about their health or these products
Please refer to the following website in Health Canada for details:
http://www.hc-sc.gc.ca/ahc-asc/media/../2012_157-eng.php
In Hong Kong, there are 145 proton pump inhibitor drugs registered. The ingredients include esomeprazole, lansoprazole, dexlansoprazole, omeprazole, pantoprazole and rabeprazole. All these products are prescription-only medicines except the products containing omeprazole. In view of Health Canada’s action, a letter to healthcare professionals about the new safety information will be issued. The matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, October 20, 2012
Issued at HKT 12:00
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