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.

• The FDA posted analysis of laboratory testing on rifapentine and rifampin products for nitrosamines. (January 28, 2021)
• The CDC Division of TB Elimination issued a Dear Colleague letter to provide an 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. (September 11, 2020)