FDA finds high levels of carcinogen NDMA in some metformin products in US

FDA is reaching out to companies whose drugs had NDMA over accepted levels. It is suggested some recalls in US are expected soon. In December, the FDA had started an investigation into whether metformin contains NDMA, and whether it is above acceptable daily intake limit of 96ng.

SPS commentary:

In Dec 2019, the European Medicines Agency found that levels of NDMA in affected non-EU metformin medicines were very low and appear to be within or even below the range that people can be exposed to from other sources, including certain foods and water. At that point, it stressed that there are no data indicating that EU metformin medicines are affected and patients in the EU should continue taking their metformin medicines as normal as the risk from not having adequate diabetes treatment far outweighs possible effects of the low levels of NDMA seen in tests.


Reuters Health

Resource links:

EMA update