NDMA investigation leads to cases discovered in diabetes treatment
Both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have released regular updates into their investigations into the causes of medicine contamination with nitrosamines.
With a number of ‘sartan’ medications affected by recalls, the FDA expedited the approval of a valsartan generic earlier this year. While various companies issued voluntary recalls due to the finding of similar contamination in ranitidine medicines.
The global investigation has now expanded to include metformin treatment, after the Singaporean government revealed that it had recalled three out of 46 metformin medicines on the market. Again, this action had been taken due to the presence of N-nitrosodimethylamine (NDMA).
In the US and the European Union (EU), there are currently no recalls of the oral diabetes treatment and the EMA stated that “there are no data indicating that EU metformin medicines are affected” – though both agencies noted that they were engaging in the expedited testing of metformin medicines.
The FDA emphasized the low risk posed by ingesting NDMA, or such substances, at levels that the agency deems acceptable, adding that it is possible to take a drug with low levels of NDMA every day for 70 years without an increased risk of cancer.
Despite moving to reassure patients taking the treatment, the agency also warned that further medicines could be discovered to be contaminated with nitrosamines, as the investigation continues.
A statement from Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, read: “As our investigations and testing continues, along with the investigations done by other drug regulatory agencies, we may find low levels of nitrosamines in additional drugs.”