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Appendix C

National Surveillance for Severe Adverse Events Associated with Treatment for Latent Tuberculosis Infection — Reporting Information

This information is included to alert our public health partners to the importance of reporting se­vere (i.e., hospitalization or death) adverse events associated with treatment for latent TB infec­tion (LTBI). Data regarding severe adverse events (SAEs) among persons receiving treatment for LTBI are needed to serve as a basis for periodic evaluation of LTBI treatment guidelines.

In April 2000, after the publication of updated Guidelines for Targeted Tuberculin Testing and Treat­ment of Latent Tuberculosis Infection,¹ CDC’s Division of Tuberculosis Elimination (DTBE) began receiving reports of SAEs related to use of a 2-month course of rifampin and pyrazinamide for LTBI treatment. In response, DTBE requested and received reports and conducted on-site investigations of liver injury among persons on LTBI treatment, and treatment guidelines were revised to recommend against the general use of rifampin and pyrazinamide for treating LTBI.^2,3 In January 2004, DTBE implemented the National Surveillance System for Severe Adverse Events Associated with Treat­ment for LTBI, which collects reports about SAEs associated with any LTBI treatment regimen, to quantify the frequency of SAEs and to characterize the clinical features of affected patients.⁴

Local medical providers should report possible LTBI treatment-associated SAEs to their respec­tive local or state health departments. State health departments should report SAEs that occurred on or after January 1, 2004, to DTBE (e-mail: LTBIdrugevents@cdc.gov). Any SAEs should also be reported to the U.S. Food and Drug Administration’s MedWatch program, using the Online Voluntary Reporting Form available at: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.homeexternal icon.