Contamination with NDMA: recall for diabetes medication
A few weeks ago, the Federal Institute for Drugs and Medical Devices (BfArM) reported that traces of the contaminant N-nitrosodimethylamine (NDMA) had been found in medicinal products containing metformin outside the European Union (EU). Several batches of diabetes medication are now being recalled in Switzerland.
At the beginning of December, the BfArM informed of traces of an impurity, N-nitrosodimethylamine (NDMA), in a small number of medicinal products containing metformin outside the European Union (EU). Initially, there was no data to suggest that medicinal products on the EU market are affected. A recall has now been launched in Switzerland for the first batches of metformin.
Avoid the presence of nitrosamines in medicines
In the past year, some blood pressure medications, the so-called sartans NDMA and other impurities of the same class (nitrosamines) have been detected.
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 avoid the presence of nitrosamines in medicines, including metformin.
On December 6, the BfArM reported that traces of contamination with NDMA were found in a small number of medicinal products containing metformin outside the EU.
"The NDMA content found in the medicinal products containing metformin is very low and appears to be within or below the range to which humans can be exposed from other sources, including certain foods and water," said the Federal Institute.
Recall of several batches of metformin from a Swiss company
At the time, there was no data to suggest that medicinal products on the EU market are affected.
"The European monitoring authorities are currently working together with the pharmaceutical companies to test the corresponding medicinal products on the European market and will provide further information as soon as they are available," said the BfArM.
The Swiss Medicines Agency, Swissmedic, now provides information on its website about the recall of several batches of metformin from the Swiss pharmaceutical company Streuli Pharma AG.
Delivery took place from mid-2015 to the end of 2019
In a company letter, the company stated that a total of 20 batches of Metformin Streuli® 500 mg, 850 mg and 1000 mg would be recalled to the retail level.
According to the information, the goods were delivered between June 2015 and December 2019.
"The reason for the recall is a slight contamination with the nitrosamine NDMA, which was detected in the finished product. The Swissmedic OMCL laboratory found this out during a test, ”writes the pharmaceutical manufacturer.
There are currently no reports of contaminated medicinal products containing metformin in Germany.
Drug for the treatment of diabetes
At the beginning of December, the BfArM recommended that patients in the EU continue to take their medicines containing metformin as usual.
According to the federal institute, the risks that result from inadequate diabetes treatment far outweigh the possible effects of the low NDMA values found in the studies.
In addition, doctors were asked to remind patients of the importance of treating diabetes adequately.
Metformin is often used alone or in combination with other medicines to treat type 2 diabetes mellitus. The drug reduces the production of glucose in the body and its absorption from the intestine. (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.