New presence of nitrosamines in antibacterial drugs based on rifampicin in EU and US

New investigations havepermitted to detect the presence of nitrosamine impurities (1-nitroso-4-methyl piperazine, MeNP) in certain samples of Rifampicin. Rifampicin is antibacterial drugs used to treat tuberculosis, and it is also used to treat other serious infections. Since it is an essential first-line treatment, the risk to patients from not taking their medicines far outweighs any potential risk from, but it is necessary to monitor the levels of impurity in the products involved.

In Europe

Authorities in the EU are investigating the presence of the MeNP in some batches of active substances used in rifampicin medicines. The CMDh (Coordination group for Mutual recognition and Decentralised procedures – Human) is working to ensure adequate testing of active substances and is liaising with the companies concerned. While the risk to patients from not taking their rifampicin medicines far outweighs any potential risk from MeNP, healthcare professionals can continue to prescribe rifampicin medicines.

In the US

The FDA became recently aware of nitrosamine impurities in certain samples of rifampicin. To mitigate or avoid shortages and to help ensuring patients access to these drugs, the FDA will not object to certain manufacturers temporarily distributing rifampicin containing 1-methyl-4-nitrosopiperazine (MNP) above the acceptable intake limits (0.16 ppm) until they can reduce or eliminate the impurities.

Our support

Mérieux NutriSciences Task Force Lab –created to promptly tackle the nitrosamines alert– has developed a target method to identify the presence of 1-nitroso-4-methyl piperazine (MeNP) in pharmaceutical products and API.

Moreover, our laboratories have developed the multiresidual method for the simultaneous determination of 14 nitrosamine impurities to offer a quick answer on product safety.