Pharmaceutical giant Apotex Inc. is voluntarily recalling a certain type of diabetes drug after one of the batches revealed elevated levels of a cancer-related contaminant. Health Canada announced on Saturday that the recall was in effect for APO-METFORMIN ER (extended release) 500 mg tablets of Apotex’s metformin drug.
The public health agency said the drug manufacturer’s test results showed that one batch (PY7174) contains a nitrosamine impurity called N-nitrosodimethylamine (NDMA) which “has increased over time to a level greater than the acceptable limit “.
The advisory said that Apotex was recalling eight more batches of drugs as a precaution, as the levels of NDMA in these products “may increase over time”.
Health Canada has shared a list of affected lots on its website.
Metformin-containing drugs are widely used to treat people with type 2 diabetes because they can reduce excess blood sugar.
In recent months, however, the safety of patients who ingest NDMA for many years has raised growing concern.
The organic compound can be taken in small doses for a lifetime, but it can be potentially carcinogenic if taken in larger amounts.
Health Canada says people are exposed to low levels of nitrosamines through a variety of foods, including smoked and salted meats, dairy products and vegetables, as well as through drinking water and pollution air.
“NDMA is not expected to cause harm when ingested at low levels,” said the health agency. “A person who has taken a drug containing NDMA at or below the acceptable level every day for 70 years should not have an increased risk of cancer. ”
The Apotex recall is the latest in a series of recent drug recalls containing metformin.
In March, JAMP Pharma Corporation voluntarily recalled 26 lots of its metformin drug due to “the potential presence of nitrosamine impurities in the finished product”. And Ranbaxy Pharmaceuticals Canada Inc. recalled six lots of its prescription RAN-Metformin drug from NDMA levels in February.
Also in February, Health Canada issued a similar recall for eight lots of Apotex APO-Metformin ER tablets sold in 500-milligram tablets.
The public health agency has advised patients taking any of the affected medications not to stop taking them without first talking to their health care provider.
“The risks of not having adequate diabetes treatment outweigh the possible effects of exposure to nitrosamine levels found in the recalled Apotex metformin products,” the agency said in a statement.