WINNIPEG -- JAMP Pharma Corporation is voluntarily recalling certain diabetes drugs due the possible presence of carcinogen NDMA.
On March 11 it was announced the company is recalling 26 lots of prescription Metformin and Metformin DIN 02380218 (850 mg) from the Canadian marketplace for precautionary reasons.
According to the Government of Canada, though NDMA tests results aren’t available for the drug, it’s being recalled due to the “potential presence of nitrosamine impurities.”
On Feb. 5, Apotex Inc. recalled eight lots of APO-Metformin ER (extended release) 500 mg tablets. The government said this diabetes drug had a nitrosamine impurity called N-nitrosodimethylamine, or NDMA, above the acceptable limit.
Later in the month, on Feb. 26, Ranbaxy Pharmaceuticals recalled six lots of prescription RAN-Metformin from the Canadian market after testing identified two lots with NDMA levels above what is considered acceptable if the drug is taken over a lifetime. The additional four lots were recalled because their NDMA levels are close to the acceptable limit.
In December 2019, Health Canada said it’s looking into the issue of NDMA in metformin after some products outside of Canada were found to contain levels above the normal limit.
Those who take the recalled product should not stop taking the drug without consulting with their health-care provider, because the risks of not having proper diabetes treatment outweigh the risk of exposure to NDMA in the medication. If someone stops using metformin it can cause uncontrolled diabetes, which can lead to high blood sugars and longer-term health issues such as heart disease, nerve problems, kidney damage, blindness and amputations.
Metformin is a prescription medication used to control high blood sugar in people with type 2 diabetes. NDMA is a probable human carcinogen. If it’s ingested at a low level, it doesn’t cause harm.
Health Canada continues to investigate the issue.
A full list of the recalled products can be found online.
