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Carcinogenic nitrosamines in diabetes and hypertension medications


Hypertension and diabetes medication: prevent contamination

In recent months and years it has been known that various hypertension and diabetes medications have been contaminated with the nitrosamine N-nitrosodimethylamine (NDMA). Numerous authorities continue to work to prevent the presence of such contaminants in medicinal products from the European Union (EU).

The contamination of high blood pressure and diabetes drugs with potentially carcinogenic nitrosamines has recently resulted in a number of these drugs having to be recalled. The problem does not seem to have been finally resolved.

Classified as potentially carcinogenic in humans

As the Federal Institute for Drugs and Medical Devices (BfArM) reports in a recent communication, the European Medicines Agency (EMA) and the national authorities continue to work on preventing the presence of nitrosamine contaminants in medicinal products from the European Union (EU).

According to experts, nitrosamines are classified as potentially carcinogenic in humans based on animal experiments. The substances are found in some foods and drinking water.

According to the BfArM, nitrosamines are not expected to cause damage if the intake is very low. With the few medicinal products for which nitrosamines have been detected, the risk for patients is therefore assessed as low.

Further results are expected

The causes of the presence of the nitrosamine N-nitrosodimethylamine (NDMA) in some batches of ranitidine are currently being investigated as part of a process initiated by the EMA's Committee for Medicinal Products for Human Use (CHMP).

Ranitidine medications are used to treat and prevent diseases caused by excess acid in the stomach, such as heartburn and stomach ulcers.

In addition, the EMA and the national authorities assess the importance of current results in which NDMA has been identified in some batches of medicinal products containing metformin (used to treat type 2 diabetes mellitus) in the EU.

Further results on analyzes of drugs containing metformin are expected.

In the past, NDMA contaminants have also been detected in some blood pressure medications, the so-called sartans.

Recommendations for patients

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

According to the experts, the risk of inadequate treatment of diabetes far outweighs the possible risks that result from the intake of low nitrosamine concentrations.

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



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