EU metformin supply appears free from NDMA contamination

  • European Medicines Agency
  • 6 dic. 2019

  • de Craig Hicks
  • Clinical Essentials
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Takeaway

  • Type 2 diabetes medicines in the European Union (EU) are not affected by the contamination that sparked government-issued recalls in Singapore, where trace amounts of N-nitrosodimethylamine (NDMA) were found in some metformin-containing drugs, says the European Medicines Agency (EMA).

What healthcare professionals should do

  • The EMA recommends that doctors continue prescribing metformin-containing medicines as usual, and that they await more information from EU and national authorities.
  • Healthcare professionals should counsel patients against stopping diabetes treatment and remind them of the importance of keeping their diabetes under control.

What patients should do

  • The EMA recommends patients continue receiving metformin to control their diabetes, cautioning that the risks from discontinuing treatment far outweigh any possible effects resulting from exposure to low levels of NDMA.

What the EMA and national authorities are doing

  • The EMA and national authorities are working closely with drug manufacturers to test EU medicines for NDMA contamination, and will provide more information when it becomes available.
  • The agency has issued a request to manufacturers specifying steps to reduce NDMA contamination risk, with instructions to notify authorities immediately if contamination is detected.