To Study Adverse Drug Reactions in MDR Pulmonary Tuberculosis Patients

Abstract

Aim: To Study Adverse Drug Reactions In MDR Pulmonary Tuberculosis Patients. Methods: The Prospective Observational Study was carried out on patients of MDR/XDR Pulmonary Tuberculosis, registered at DR-TB Centre attended in OPD or admitted in DOTS Plus Site, Medical College, SSG Hospital, Vadodara for any adverse drug reaction, from January-2017 to October-2017. Total 80 MDR/XDR TB patients, who were registered at DR-TB Centre Baroda, were enrolled in the study for duration of 10 months. Results: Out of 80 patients most common Adverse drug reactions are gastro-intestinal upset 44/80 (55%), Arthralgia 14/80 (17.25%), Ototoxicity 12/80 (15%) and Psychiatric disturbances 5/80 (6.25%). Neuropathy 4/80 (5%), skin reactions 4/80 (5%), hypothyroidism 3/80 (3.75%) , and hepatotoxicity 3/80 (3.75%) also had been noted. Local toxicity, Visual disturbances, hypokalemia & Renal toxicity noted rarely. Out of 59 male patients most common Adverse drug reactions are gastro-intestinal upset (32 cases), Arthralgia (10 cases), Ototoxicity (10 cases) and Psychiatric disturbances(5 cases). Out of 21 female patients most common Adverse drug reactions are gastro-intestinal upset (12 cases), Arthralgia (4 cases), Ototoxicity (2 cases), Neuropathy ( 2 cases) and Skin reaction (2 cases). We had stopped the offending drug permanently in 16.3% of the patients. In 22.7% of patients, drug stopped upto recovery from adverse drug events. But in 61% of patients does not required the discontinuation of the offending drug. In some cases dosage of the drug is divided. As per the Preventibility Criteria According To Schumock And Thornton Scale, 62/80 (77.5%) ADRs are Not Preventable, 17/80 (21.25%) ADRs are Probably Preventable, and 1/80 (1.25%) ADRs are Definitely Preventable. Most common presenting symptoms are nausea-vomiting 44/80 (55%), Abdominal pain 18/80 (23%), Joint Pain 14/80 (18%), Hearing loss 12/80 (15%), and Breathlessness 7/80 (8.8%). Conclusion: Gastro-intestinal side effects which were commonest can be largely prevented by proper timing and spacing of drugs with food and if necessary, giving antiemetic, antacids and PPIs or H2 receptor blockers. These side effects are a common cause of defaulting and persuasive, sincere counseling is vital to help the patients through this ADR.