A safety analysis of different drug regimens used in human immunodeficiency virus-positive patients.

BACKGROUND: Long-term toxicity of antiretroviral agents is rarely addressed in initial clinical trials. Effective pharmacovigilance is essential for long-term safety of antiretroviral therapy (ART). MATERIALS AND METHODS: All adverse drug reactions (ADRs) reported due to ART between January 2014 and September 2016 were analyzed as per different drug regimens used. ADRs were also analyzed for system organ classification, seriousness, time relationship of ADRs with drug therapy, causality (as per the World Health Organization-Uppsala Monitoring Centre scale and Naranjo algorithm), and severity (Hartwig and Siegel scale). Comparison was done between (tenofovir + lamivudine + efavirenz [TLE]) and (zidovudine + lamivudine + nevirapine [ZLN]) regimens. RESULTS: During a study period, 2983 patients were on ART. The most common drug regimen prescribed was TLE (1805) followed by ZLN (326). A total of 325 (10.89%) ADRs were reported in which 150 ADRs were reported in TLE regimens (46%) and 130 in ZLN regimens (40%). The mean age of patients with ADRs was 40 ± 12.56 years and men (58.1%) were more affected than women (41.8%). The most common system organ involved in ZLN regimen was blood (50, 39%) and skin (35, 27%), while it was neurological (63, 42%) and renal disorder (27, 18%) in TLE regimen. Most of ADRs were observed after 1 month of therapy (79.5%) and showed possible causal relation with drug therapy (78.15%). Majority of ADRs were mild in nature (86.7%). The serious ADRs were reported more in ZLN (18%) regimen as compared to TLE (9%) (P < 0.05). CONCLUSION: Both ART regimens are associated with ADRs affecting all body system; however, the frequency and severity of ADR are high with ZLN regimen.

Comparison of Effect of Antidepressants on Psychomotor Functions.

OBJECTIVE: The comparison of the effect of antidepressants on psychomotor functions in patients with endogenous depression. MATERIALS AND METHODS: This prospective interventional study was carried out at a tertiary care teaching hospital on 95 literate patients with newly diagnosed endogenous depression matching inclusion and exclusion criteria. Patients were prescribed either desvenlafaxine (50 mg) or fluoxetine (40 mg) or sertraline (50 mg). Psychomotor functions were assessed by digit letter substitution, six letter cancellation, choice reaction time, hand steadiness and flicker fusion test at the baseline 1st month and 3rd month. Efficacy of drugs was also measured by Hamilton rating scale for depression. Data were analyzed by using ANOVA and P < 0.05 was considered as statistically significant. RESULTS: A total of 95 patients were enrolled. Fluoxetine, desvenlafaxine, and sertraline were prescribed in 32, 32, and 31 patients, respectively. At the end of 3 months, a significant improvement in psychomotor functions was observed in patients treated with sertraline (P < 0.05), while desvenlafaxine-treated patients did not show any significant change in any of the tests. Surprisingly, fluoxetine-treated patients showed deterioration in all psychomotor tests (P < 0.05). Hamilton rating score improved at the end of 3 months treatment as compared to baseline. Most commonly observed adverse reactions in all three drug groups were nausea (n = 20), dizziness (n = 3), headache (n = 20), and diarrhea (n = 3). CONCLUSION: Sertraline significantly improves psychomotor function as compared to desvenlafaxine while fluoxetine impairs.

Intensive monitoring of adverse drug reactions in hospitalized patients of two medical units at a tertiary care teaching hospital.

OBJECTIVE: To detect incidence of adverse drug reactions (ADRs) in hospitalized patients and to assess their causality, seriousness, preventability, and the possible economic impact. MATERIALS AND METHODS: This was a prospective study carried out in two medical units at a tertiary care, teaching hospital, for about 18 months. All the admitted patients who developed an ADR after admission (group A) or who were admitted primarily for the treatment of an ADR (group B) were included. Descriptive statistics with 95% CI, χ(2), χ(2) for the trend and kappa test were used. RESULTS: Out of 6601 patients, 140 patients developed 154 ADRs with an incidence of 2.12%. Causality of the majority of the ADRs in group A was 'possible' while those in group B was 'probable'. Among 109 ADRs (34 serious) in group A, 38 were preventable. On the other hand, out of 45 serious ADRs in group B, 19 were preventable. The total cost of 154 ADRs in 140 patients was Rs. 1,49,803 with an average of Rs. 1070 per patient. The preventable cost for 57/154 ADR was Rs. 96,310. CONCLUSION: Around 2% of the hospital patients develop ADRs. A large number of these ADRs were preventable. A substantial saving can be made if adequate caution is exerted.

Steroid-induced central serous retinopathy.

A-24 year-old male was prescribed prednisolone (60 mg/day) for left sided facial palsy. After three days of therapy, the patient complained of black spots in his vision in right eye. Fluorescein angiography of right eye showed evidence of central serous retinopathy (CSR). Prednisolone dose was withdrawn gradually and the patient improved within a week. There were no other systemic or ophthalmic diseases reported by the patient, which could have caused this condition. An improvement after dechallenge confirmed steroid-induced CSR. Recurrent CSR is known to cause permanent loss of vision. Hence, awareness regarding this adverse drug reaction (ADR) with steroids and its reporting can minimize this complication and help in better patient management.