Nitrosamine Contamination
Concerns about nitrosamine contamination in rifapentine and rifampin are under investigation. As more information is gathered and issued, a summary of what is currently known and recommended will be listed below.
- TAG Information Note: N-Nitrosamines and Tuberculosis Medicines Rifampicin and Rifapentine — Summary of 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. (Treatment Action Group, February 2021)
- Nitrosamines and TB Medicines: What People Taking TB Preventive Therapy Need to Know — Frequently asked questions about nitrosamines for people taking treatment for TB infection. (Treatment Action Group, February 2021)
- Nitrosamines and TB Medicines: What People Taking TB Treatment Need to Know — Frequently asked questions about nitrosamines for people taking TB treatment. (Treatment Action Group, February 2021)
- Laboratory Analysis of Rifapentine/Rifampin Products — Drug safety information concerning nitrosamines. (Food and Drug Administration, January 28, 2021)
- Dear Colleague Letter — Update on shortages of rifampin and rifapentine and FDA’s interim guidance on using these drugs to treat for TB after nitrosamine-class impurities were detected through recently adopted regulatory standards to assay all medications for nitrosamines. (CDC Division of TB Elimination, September 11, 2020)
