For the latest information on cancer-causing nitrosamines in Diabetes drugs
Millions of people suffer from type 2 Diabetes mellitus. Many of these patients are treated with Metformin. However, in the past, it was always found that Metformin-containing medicinal products are contaminated with nitrosamines. These substances are classified as carcinogenic.
The contamination of high blood pressure and Diabetes medications with potentially cancer-causing nitrosamines has led in the last months to the medicines and still the Problem seems not solved. In a communication of the Federal Institute for drugs and medical devices (BfArM), there is now current information about nitrosamines in Metformin-containing drugs.
In addition to various high blood pressure were also contaminated with Diabetes medications with the Nitrosamine N-nitroso dimethyl amine (NDMA).
According to an older press release of the European medicines Agency EMA and to the coordination group for mutual recognition and decentralised procedures (CMDh) to assess the national authorities furthermore, the effects of the current studies in which NDMA in some batches of Metformin-containing medicinal products in the EU was detected.
Metformin is used for the treatment of type 2 Diabetes mellitus.
As potentially carcinogenic in humans classified
The BfArM is that nitrosamines will try on the basis of animal as potentially carcinogenic in humans are classified. They are also included in some food and drinking water.
“It is not expected that nitrosamines can cause in a very low shooting damage,” writes the Institute.
In the case of the few drugs in which nitrosamines have been detected, is considered to be the risk to patients is low.
Impact of the COVID-19-pandemic on the provision of the test results
Further results of analyses, Metformin-containing medicinal products in the EU, according to the BfArM still.
Marketing authorisation holders are reminded, therefore, to take into account all known causes, including the packaging materials used and any possible source of nitro-organizing agents in their investigations.
The information, according to the CMDh has established that the COVID-19-effects of the pandemic on the provision of the test results, and therefore decided that the current deadline for the submission of results of Analysis for active ingredient and finished medicinal product batches (marketed and the release of standing) and the corresponding investigation reports that include the corrective and preventive measures the marketing authorisation holder, to the 01. October 2020 can be expanded.
An assessment phase is then followed by the national medicines authorities. According to the experts is notified of the results of these reviews, as soon as it is available.
Treatment not cancel
In line with previous recommendations to patients and patients to take your Metformin-containing medicines continue to as usual.
“The risk of insufficient treatment of Diabetes far outweighs the possible risks arising from the consumption of low nitrosamine concentrations,” warns the BfArM.
And: “discontinuation of treatment can be caused lead to inadequate treatment of Diabetes and, therefore, symptoms due to high blood sugar levels, including thirst, tiredness and blurred vision.”
To include the long-term complications of untreated Diabetes, heart disease, nerve problems, kidney damage, eye problems and damage to the blood circulation of the foot, which can lead to amputations.
As Metformin is considered to be critical drug, the EMA and the national authorities closely, to avoid potential supply shortages so that those Affected can continue to receive the treatments they need. (ad)
Authors and source of information
This Text meets the requirements of the medical literature, medical guidelines, as well as current studies and was examined by doctors and Medical scientists.