Health Canada announces that it is aware that some metformin products available outside Canada have been found to contain a nitrosamine impurity, N-nitrosodimethylamine (NDMA), above the acceptable limit. At this time, Health Canada is not aware of any metformin products in Canada containing NDMA above acceptable levels. The Department has asked companies to test their metformin products and is collecting samples from companies to conduct its own testing. Health Canada is also working closely with international regulatory partners to inform its assessment of the issue and to determine whether any metformin product in Canada is affected. If a risk to Canadians is identified, the Department will take action as needed and inform Canadians.
Patients should not stop taking their metformin drug without first discussing options with their health care provider. While Health Canada is not aware of any affected products in Canada at this time, it is important to note that the risks from not having adequate diabetes treatment far outweigh any possible effects of exposure to the levels of NDMA found in metformin in other countries. Stopping metformin medication could lead to uncontrolled diabetes, which has serious health risks. Immediate symptoms of high blood sugars include increased urination, thirst, excessive hunger, fatigue, blurred vision, drowsiness, irritability, unintended weight loss and dizziness. Very high blood sugars can lead to effects such as vomiting, diarrhea, dehydration, confusion, agitation and coma. Longer-term serious health risks include heart disease, nerve problems, kidney damage, blindness and amputations.
NDMA is classified as a probable human carcinogen. We are all exposed to low levels of nitrosamines through a variety of foods (such as smoked and cured meats, dairy products and vegetables), drinking water and air pollution. NDMA is not expected to cause harm when ingested at low levels. A person taking a drug that contains NDMA at or below the acceptable level every day for 70 years is not expected to have an increased risk of cancer.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../71831a-eng.php
Currently in Hong Kong, there are 125 registered pharmaceutical products containing metformin. All products are prescription-only medicines. So far, the DH has received 17 cases of adverse drug reaction related to metformin. None of them is concluded to be related to the presence of NDMA.
Related news on the detection of N-nitrosodimethylamine (NDMA) in metformin products was previously issued by Singapore Health Sciences Authority (HSA), and was posted on the Drug Office website on 5 Dec 2019. Letters to inform local healthcare professionals will be issued. The DH has contacted the HSA for further information regarding the detection of NDMA in metformin products and reply is pending. The DH has been contacting the certificate holders of all registered metformin products for follow up on the local impact of the issue. The DH is collecting samples of metformin-containing products in the local market for analysis. When any health risks are posed to the public, a press statement will be issued as soon as possible. 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 metformin-containing products should not stop taking the medicines, but should seek advice from their healthcare professionals for proper arrangement.
Ends/ Friday, Dec 6, 2019
Issued at HKT 16:00
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