TABLE 5.
Identification of suspected drugs, frequency, and management of ADRs among DR-TB patients (n = 271).
| Adverse drug reaction | Suspected drugs | ADR frequency (%) | Action taken | Modified RR/MDR-TB regiment | Type of Action taken | ||
|---|---|---|---|---|---|---|---|
| Dose reduction | Temporary withdrawal | Permanent withdrawal | |||||
| Gastrointestinal Disturbances | 181 (66.7) | ||||||
| Gastrointestinal upset | H, PAS, Cs, Eto | 146 (53.8) | Counselled and reassured. Patients were prescribed PPI along with prokinetics drugs. Medication was modified for one patient and was replaced with Lzd | PAS (1) | PAS (1) | ||
| Nausea and Vomiting | PAS | 29 (10.7) | Counselled and reassured. All patients were prescribed domperidone along with prokinetics drugs. PAS dose was reduced in one patient | PAS (1) | |||
| Diarrhea | PAS, H | 4 (1.47) | Patients were prescribed diosmectite powder | ||||
| Hiccups | — | 1 (0.36) | The patient was prescribed Baclofen along with PPI | — | |||
| Oral Ulcer | — | 1 (0.36) | The patient was prescribed Lignocaine gel and advised for use of mouthwash | ||||
| Nervous System Disorders | Cs | 161 (59.4) | — | — | — | — | |
| Depression | Cs | 75 (27.6) | Counselled and prescribed SSRI antidepressants. The dose of Vit B6 was also increased. The offending agent was withheld temporarily in one patient and dose was reduced in another patient | Cs (2) | Cs (1) | Cs (1) | — |
| Sleep disturbances | Cs | 48 (17.7) | All patients were counselled and prescribed Benzodiazepines | None | — | — | — |
| Psychosis | Cs | 27 (10) | All the patients were prescribed antipsychotic medication after referral to the psychiatry ward. 27 patients were prescribed risperidone. The offending drug was temporarily and permanently stopped in two and one patient, respectively, and dose was reduced in one patient | Cs (5) | Cs (2) | Cs (2) | Cs (1) |
| Aggression | Cs | 5 (1.84) | Counselled and referred to the psychiatry ward. All patients were prescribed Fluphenazine HCl and nortriptyline | None | — | — | — |
| Visual disturbances | — | 4 (1.47) | Patients were counselled and were referred to an ophthalmologist. Vit B6 dose was increased in all patients | None | |||
| Memory loss | Cs | 2 (0.7) | The patients were prescribed a higher dose of Vit B6 | None | — | — | — |
| Electrolyte disturbances | Am | 151 (55.7) | Patients were monitored and two patients were advised for potassium-rich food and a potassium supplement was added to two patients’ treatment regimen due to Hypokalemia | None | |||
| Arthralgia/Hyperuricemia | Z, Cs, H | 137 (49.1) | Patients were prescribed NSAIDs for symptomatic relief. One patient was prescribed Allopurinol and dose of Z was reduced in another patient | Z (1) | Z (1) | ||
| Ototoxicity | Am, S | 65 (24) | Counselled. Am was replaced to Cm in 33 patients and dose was reduced in nine patients while use was withheld temporarily and permanently in one and three patients, respectively. Nine patients were kept without management as they had completed their injectable treatment and this ADR was subsided | Am (45) S (1) | Am (9) | Am (1) | Am (3) |
| Pruritis/Rash/Acne | Am | 35 (12.9) | Counselling was provided to patients. Antihistamine and hydrocortisone therapy was prescribed along with the use of r | Skin emollients. Fusidic acid was prescribed for one patient. Two patients were prescribed anti-acne therapy | None | ||
| Dyspnoea | 34 (12.5) | All patients were counselled and prescribed a bronchodilator | None | ||||
| Body Pain and Headache | 27 (10) | All patients were counselled and prescribed NSAIDs | None | ||||
| Tinnitus | Am, Cm, Eto | 24 (8.8) | All patients were counselled and prescribed Betahistine. The Injection was stopped temporarily in one patient and advised on an alternate day in another patient | Cm (2) | Cm (1) | Cm (1) | — |
| Peripheral neuropathy | Cs | 14 (5.2) | All patients were counselled and prescribed duloxetine and vit B6 dose was increased | None | |||
| Anorexia | — | 7 (2.58) | All patients were prescribed appetizers and multivitamins | None | |||
| Hypothyroidism | PAS | 5 (1.84) | All were counselled and prescribed thyroxine. Use of the offending agent was stopped in one patient and dose was reduced in another patient | PAS (2) | PAS (1) | PAS (1) | |
| Dizziness | Z, Cs | 4 (1.47) | Patients were counselled. The dose of Vit B6 was increased in all patients. Z was advised to be taken on an alternate day in one patient. one patient was prescribed Prochlorperazine, and another patient was prescribed Betahistine | Z (1) | Z (1) | ||
| Hemoptysis | 3 (1.1) | Patients were counselled. All three patients were prescribed Tranexamic acid | None | ||||
| Anemia | PAS | 2 (0.7) | Patients were counselled. One patient was prescribed for iron supplement and one patient was advised for blood transfusion along with the temporary withdrawal of the offending agents | PAS (2) | PAS (2) | ||
| Nephrotoxicity | Cm | 2 (0.7) | Patients were counselled and prescribed prednisolone along with the removal of the offending agent permanently in one patient and replaced with Lzd in another patient | Cm (2) | Cm (2) | ||
| Palpitations | 2 (0.7) | Counselling was provided to the patients. Beta-blockers were prescribed | None | ||||
| Gynecomastia | 2 (0.7) | NSAIDs were added to patients’ treatment along with counselling | None | ||||
| Menstrual irregularities | Eto | 1 (0.36) | The patient was counselled and referred to a gynecologist | None | |||
| Photosensitivity | Eto | 1 (0.36) | The patient was prescribed a higher dose of Vit B6 | None | |||
| Swelling | 1 (0.36) | The patient was counselled and prescribed a diuretic | None | ||||
H, isoniazid; Cs, cycloserine; Eto, ethionamide; PAS, para-amino salicylic acid; Z, pyrazinamide; Am, amikacin; Cm, capreomycin; S, streptomycin; NSAID, non-steroidal anti-inflammatory drugs; Lzd, linezolid; vit, vitamin.