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Diabetes medication contaminated with NDMA

Diabetes medication contaminated with NDMA


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Potentially carcinogenic nitrosamines in medicines used to control blood sugar

Various medicines for high blood pressure and heartburn have been recalled in recent months because of the presence of traces of the nitrosamine N-nitrosodimethylamine (NDMA). Now it has become known that diabetes medications are also contaminated with this substance. NDMA is classified as likely to cause cancer in humans.

Traces of contamination, N-nitrosodimethylamine (NDMA), have been found in a small number of medicinal products containing metformin outside the European Union (EU), reports the Federal Institute for Drugs and Medical Devices (BfArM). The NDMA levels found in these drugs are reported to be very low and appear to be within or below the range to which humans may be exposed from other sources, including certain foods and water.

Medicines should continue to be taken as usual

According to the BfArM, there are currently no data available (as of December 6, 2019) that indicate that medicinal products on the market in the EU are affected.

The European supervisory authorities are currently working with pharmaceutical companies to test medicinal products on the European market and will provide more information as soon as they are available.

Patients in the EU are recommended to continue taking their medicines containing metformin as usual. According to the BfArM, the risks resulting from inadequate diabetes treatment far outweigh the possible effects of the low NDMA values ​​found in the studies.

Physicians are also asked to remind patients of the importance of treating diabetes adequately. Metformin is often used alone or in combination with other medications to treat type 2 diabetes mellitus. The medicine reduces the production of glucose in the body and its absorption from the intestine.

Stopping treatment can be dangerous

The BfArM has summarized some important information for patients:

  • Metformin is an effective medicine for controlling blood sugar levels.
  • Continue taking your medicines containing metformin to treat your diabetes adequately.
  • Discontinuation of treatment may lead to inadequate treatment of diabetes and therefore symptoms caused by high blood sugar, including thirst, tiredness and blurred vision.
  • Long-term complications of untreated diabetes include heart disease, nerve problems, kidney damage, eye problems, and blood flow to the foot that can lead to amputations.

The BfArM recommends medical professionals:

  • Continue prescribing medicinal products containing metformin as usual and wait for further information from the European authorities.
  • Instruct your patients not to stop their diabetes treatment.
  • Remind your patients of the importance of treating diabetes adequately.

Classified as likely to cause cancer in humans

As the institute explains, based on animal studies, NDMA is classified as likely to be carcinogenic in humans. The substance is found in some foods and drinking water. However, it is not expected to cause damage with a very low intake.

Only a few months ago there was a recall for gastric acid blockers in the European Union because it also found contamination with NDMA.

Last year, NDMA and other contaminants of the same class (nitrosamines) were also found in some blood pressure medications called sartans.

The European Medicines Agency (EMA) then initiated a review of all ranitidine-containing medicines and a process that called on pharmaceutical companies to take specific measures to prevent the presence of nitrosamines in human medicines, including metformin, or below acceptable limits the BfArM reported.

This process is ongoing and will serve as a guide for pharmaceutical companies and to support the analysis of data on nitrosamines. The accelerated testing of medicinal products containing metformin in the EU is part of this procedure.

According to the information, the EMA and the national authorities, together with international partners and the European Directorate for the Quality of Medicines (EDQM), continuously exchange information about contaminants such as NDMA and take measures to protect the health of patients and to ensure the quality of Medicines. (ad)

Author and source information

This text corresponds to the specifications of the medical literature, medical guidelines and current studies and has been checked by medical doctors.


Video: FDA investigating whether diabetes drug Metformin contains probable carcinogen (June 2022).