Health Canada has announced the recall of a third metformin drug — a first-line treatment for diabetes — due to the presence of the probable carcinogen NDMA, while the U.S. Food and Drug Administration (FDA) is still reviewing the data to determine if a recall is necessary.
In December, both the FDA and Health Canada alerted consumers that NDMA (N-Nitrosodimethylamine) was found in the widely used diabetes drug. The impurity was identified by Valisure, the online pharmacy that in September alerted health authorities of NDMA in the heartburn drug Zantac (ranitidine) and its generics. The findings led to numerous recalls of both over-the-counter and prescription drug products containing ranitidine.
NDMA was also discovered in 2018 in several medications used to treat high blood pressure and heart failure known as angiotensin II receptor blockers, or ARBs. Several of those medications were recalled from the market in the months that followed.
On Feb. 3, following the December announcement of NDMA in metformin, the FDA announced that it had conducted testing on metformin products to determine whether the levels of NDMA in the products were high enough to require a recall. The agency said that it determined that the levels of impurity in the products it tested at that time did not exceed the acceptable daily intake for NDMA.
However, on Feb. 4, Health Canada announced the recall of eight lots of APO-Metformin 500mg tablets due to the presence of NDMA. On Feb. 26, the agency announced the recall of two lots of Ranbaxy Metformin (RAN-Metformin 850 mg tablets and RAN-Metformin 500 Tablets) due to the concentrations of NDMA above or near what the country considers acceptable.
On March 2, Valisure filed a Citizen Petition with the FDA urging the agency to request recalls of affected metformin products. The FDA didn’t think it necessary. But, on March 10, Health Canada announced a third recall involving two lots of Jamp-Metformin tablets (Jamp-Metformin 500 mg tablets and Jamp-Metformin 850mg tablets) due to elevated levels of NDMA.
The FDA still has not issued a recall of any metformin products, nor has it given the public an update since Feb. 3.
