Some metformin-containing drugs that type 2 diabetics take to lower their blood sugar levels to normal levels are suspected of being contaminated with potentially carcinogenic nitrosamines, according to a report by the Federal Institute for Drugs and Medical Devices (BfArM). However, according to experts from other authorities, patients suffering from type 2 diabetes should not simply omit or discontinue the medication because the risk of insufficient treatment of so-called diabetes is worse than the risks associated with taking such drugs with low levels of contamination. Stopping the medication could, in the worst case, lead to reduced blood circulation in the feet and thus to amputation. But heart disease, nerve damage, kidney problems and blurred vision (eye problems) could also occur if left untreated. The BfArM is investigating the problem because there have been repeated drug recalls in recent times, which have led to the authority waiting for results from EU analyses and then taking action. However, the Institute does not expect any damage from the very low uptake of the nitrosamine N-nitrosodimethylamine (NDMA) in some diabetes preparations, as the substance is also found in various food products and drinking water. The batches of metformin-containing drugs in which the substance was found are currently being analysed. However, the Covid-19 crisis situation has led to the postponement of the deadline by which the analysis results must be submitted. The cut-off date is now 1 October 2020, followed by an assessment phase by the national authorities, which is currently still pending. The result will be communicated as soon as it is available. However, marketing authorisation holders are reminded to take into account all possible sources of contamination in the analyses. This includes the materials used for packaging batches of active substances and finished medicinal products.
