Nitrosamines and TB medicines information note

TAG and IMPAACT4TB project partners release several materials to explain how the identification of nitrosamines in rifampicin and rifapentine may affect the safety and supply of TB medicines, and what this may mean for TB programs and patients.

In 2020, health authorities and drug manufacturers identified a type of chemical impurity called nitrosamines in rifampicin and rifapentine, two essential medicines used in the treatment and prevention of TB. Treatment Action Group (TAG) and IMPAACT4TB project partners have developed several materials to help people affected by TB, advocates, policymakers, and implementers understand how the identification of nitrosamines in rifampicin and rifapentine may affect the safety and supply of TB medicines, and what this may mean for TB programs and patients.

• Information Note: N-Nitrosamines and Tuberculosis Medicines Rifampicin and Rifapentine outlines what is known about nitrosamines in TB medicines and contains a technical summary of how health authorities judge the risk of nitrosamines and set acceptable intake levels. This document also contains key messages and recommended actions for people with TB, for manufacturers, for governments, and for advocates and members of civil society.

• Nitrosamines and TB Medicines: What People Taking TB Treatment or TB Preventive Treatment Need to Know answers frequently asked questions about nitrosamines for people taking TB treatment or preventive treatment.

First published by TAG in February 2021, these resources were revised and republished by TAG and IMPAACT4TB partners, including the Aurum Institute and CHAI, in March 2023. IMPAACT4TB is a project funded by Unitaid.

Source: TAG