Adverse drug reaction and its management in tuberculosis patients with multidrug resistance: a retrospective study.

OBJECTIVES

This study was conducted to assess adverse drug reactions and their management in MDR-TB patients. Indonesia is the fifth highest country with multidrug-resistant tuberculosis (MDR-TB) high burden around the world. The number of MDR-TB patients in Indonesia is increasing every year, but the data regarding ADRs are still limited. Therefore, more data on their characteristics and their management is very valuable for clinicians and pharmacists.

METHODS

The study is a descriptive study, using retrospective data of MDR-TB patients who completed therapy from January 1st, 2015 to December 31st, 2015 at the Tuberculosis Outpatient unit at the Dr. Soetomo Teaching Hospital Indonesia. Each adverse effect was judged with standards of the clinic and was documented in patients' medical records.

RESULTS

There were 40 patients included in this study. During therapy, 70% of patients developed at least one adverse drug reaction. The five most prevalent adverse effects found in this study were hyperuricemia (52.5%) followed by gastrointestinal (GI) disturbances (40%), ototoxicity (37.5%), hypokalemia (27.5%), and athralgia (12.5%). Managements that were undertaken to overcome the adverse drug reactions were adding symptomatic drugs and/or modifying the treatment regimen.

CONCLUSIONS

Because of the small samples we cannot attain a general conclusion. However, the result of this study is very imperative as this data gives us insight regarding adverse effects in MDR-TB patients in Indonesia.