Apotex Inc. recently announced a recall of certain lots of its 500 mg extended release metformin tablets (“APO-Metformin ER”) because they contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) above the acceptable limit. Apotex Inc. has tested all lots of its 500 mg extended release tablets and only the affected lots are being recalled.
As also noted in 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.”
|
PRODUCT |
DIN |
STRENGTH |
SIZE/FORMAT |
LOT |
EXP. DATE (mm/yyyy) |
|
APO-METFORMIN ER (Metformin Hydrochloride Extended-Release Tablets) |
02305062 |
500mg |
100 BTL |
NV3242 |
04/2020 |
|
NV3244 |
04/2020 |
||||
|
NV3245 |
04/2020 |
||||
|
500 BTL |
NV3243 |
04/2020 |
|||
|
NV3247 |
04/2020 |
||||
|
NV3248 |
04/2020 |
||||
|
PX5334 |
01/2021 |
||||
|
PX5335 |
01/2021 |
Given the wide-spread use of metformin, many Canadians may have concerns about the safety of their metformin medication. “We understand this news may be unsettling for all those who rely on metformin to manage their condition,” says Seema Nagpal, vice-president of Science & Policy with Diabetes Canada. “We urge 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 testing by several other Canadian manufacturers is still currently underway to determine whether any other metformin products may be affected.
Diabetes Canada will continue to provide updates through our newsroom and social media channels.