Diabetes medications can contain carcinogenic nitrosamines

Diabetes medications can contain carcinogenic nitrosamines

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Current information on carcinogenic nitrosamines in diabetes medication

Millions of people suffer from type 2 diabetes mellitus. Many of these patients are treated with metformin. However, in the past it has been repeatedly found that medicinal products containing metformin are contaminated with nitrosamines. These substances are classified as carcinogenic.

Contamination of high blood pressure and diabetes medications with potentially carcinogenic nitrosamines has repeatedly led to drug recalls in recent months and the problem still does not seem to be solved. In a communication from the Federal Institute for Drugs and Medical Devices (BfArM), there is now up-to-date information on nitrosamines in medicines containing metformin.

Contaminated medication

In addition to various high blood pressure medications, diabetes medication was also contaminated with the nitrosamine N-nitrosodimethylamine (NDMA).

According to an earlier press release from the European Medicines Agency (EMA) and the Coordination Group on Mutual Recognition and Decentralized Procedures (CMDh), national authorities continue to assess the impact of recent studies, which have identified NDMA in some batches of medicinal products containing metformin in the EU.

Metformin is used to treat type 2 diabetes mellitus.

Classified as potentially carcinogenic in humans

According to the BfArM, nitrosamines are classified as potentially carcinogenic in humans based on animal experiments. They are also found in some foods and drinking water.

"Nitrosamines are not expected to cause damage if the intake is very low," the institute writes.

With the few medicinal products for which nitrosamines have been detected, the risk for the patient is estimated to be low.

Effects of the COVID-19 pandemic on the delivery of test results

According to the BfArM, further results on analyzes of medicinal products containing metformin in the EU are still pending.

Authorization holders are therefore reminded to take into account all known causes, including the packaging materials used and any possible source of nitrosating agents, in their investigations.

According to the information provided, the CMDh determined that the COVID-19 pandemic had an impact on the provision of the test results and therefore decided that the previous deadline for submitting analytical results for batches of active substance and finished product (marketed and pending release) and the associated investigation reports, which include the corrective and preventive measures of the marketing authorization holders, can be expanded until October 01, 2020.

This is followed by an assessment phase by the national pharmaceutical authorities. According to the experts, the result of these reviews will be communicated as soon as it is available.

Do not stop treatment

In line with previous recommendations, patients should continue to take their medicines containing metformin as usual.

"The risk of inadequate treatment of diabetes far outweighs the possible risks that result from the intake of low nitrosamine concentrations," warns the BfArM.

And: "Stopping treatment can lead to inadequate treatment of diabetes and therefore symptoms that are caused by high blood sugar levels, including thirst, fatigue and blurred vision."

Long-term complications from untreated diabetes include heart disease, nerve problems, kidney damage, eye problems, and blood circulation damage to the foot that can lead to amputations.

Because metformin is considered a critical drug, the EMA and national authorities work closely together to avoid potential supply shortages so that those affected can continue to receive the treatments they need. (ad)

Author and source information

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

Video: Webinar: Nitrosamines in Medicinal Products Assessing the Risks (August 2022).