Health Canada has recently advised of a new recall regarding metformin, a medication used in the treatment of type 2 diabetes. The recall is related to the presence or possible presence of a nitrosamine impurity called N-nitrosodimethylamine (NDMA) and is related to one pharmaceutical company.
Apotex Inc. is voluntarily recalling nine additional lots of its metformin drug (APO-Metformin ER extended release) 500 mg tablets. The company had also previously announced a recall of certain lots of their 500 mg extended release tablets in earlier February due to NDMA above the acceptable limit.
As noted in previous statements, Ranbaxy Pharmaceuticals Canada Inc. also voluntarily announced a recall due to test results of NDMA over the acceptable limit. One other company, JAMP Pharma Corp. recalled certain lots as a precautionary measure.
According to Health Canada’s statement: “Individuals taking metformin, including a recalled product, should not stop taking it unless they have spoken to their health-care provider as the risks from not having adequate diabetes treatment outweigh any possible effects of exposure to the levels of NDMA found in the recalled products.”
“We understand this can be worrying and those managing their diabetes may have concerns about the safety of their metformin medication,” says Seema Nagpal, vice-president of Science & Policy with Diabetes Canada. “We advise all patients who manage their diabetes with metformin to continue their treatment regimen and to work with their health-care provider to discuss concerns.”
The contaminated products are being removed from pharmacies, so no patients receive them in the future.
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.
Health Canada advised that recent by Canadian manufacturers is now completed.
The complete list of affected products can be found on the Health Canada website Individuals are also encouraged to speak directly to their pharmacist with questions related to their metformin medication.