Adverse drug reaction profile of daily regimen antituberculosis treatment.

Objectives: The objective was to estimate the proportion of adverse drug reactions (ADRs) to daily regimen antituberculosis treatment (ATT) among the ADRs received in the ADR monitoring center (AMC) of the institution and to describe its pattern. Materials and Methods: This was a descriptive study conducted in the Department of Pharmacology of a Government Medical College in Central Kerala and the period under study was October 2017-June 2020. The data on ADR were entered into a structured pro forma and data were analyzed using SPSS for Windows Version 16.0 (SPSS Inc., Chicago, USA). Results: Of the 643 ADRs, 98 (15.24%) were suspected to be due to the daily regimen of ATT. The most common organ system affected was hepatobiliary 46 (46.9%) namely hepatitis in 35 and asymptomatic elevated liver enzymes in 11 followed by eye with 26 reports of decreased vision. In 96 (97.95%), the suspected ADR had probable causality and in 2 (2.04%) it was possible. Seventy-seven (78.6%) ADR reports were serious as well as moderate-level 4b in severity and 57 (58.16%) were probably preventable. The mean days of onset of ADR after starting the ATT regimen were 56.40 ± 58.29 days (range 1-180). Decrease in vision with a mean duration of 125.23 ± 55.46 days had the longest latency in onset among all the ADRs. Conclusions: Of all the ADRs reported to AMC 15.24% were due to the daily regimen of ATT. Hepatitis was the most common ADR encountered followed by decrease in vision. The majority of the ADRs were probable in causality, serious, moderate-level 4b in severity, and probably preventable.

Pharmacovigilance of Cutaneous Adverse Drug Reactions among Patients Attending Dermatology Department at a Tertiary Care Hospital.

CONTEXT: Cutaneous adverse drug reactions (CADRs) are the most frequent of all manifestations of drug sensitivity that present with varied and diverse morphology and therefore, awareness about them is essential for diagnosis and prevention. Aims: To evaluate the clinical spectrum, morphology, causality, severity and preventability of cutaneous adverse drug reactions in a tertiary care hospital. SETTING AND DESIGN: Descriptive study for six months in the Dermatology Department of a tertiary care hospital in Kerala. METHODS AND MATERIALS: All patients of any gender and age who presented with visible skin lesions and were diagnosed or suspected cases of cutaneous adverse drug reactions were included in the study. All the relevant information was recorded using pre-structured proforma and ADR reporting form. STATISTICAL ANALYSIS: Data were analyzed using descriptive statistics. The quantitative variables were expressed as mean ± standard deviation and qualitative variables as frequencies and percentages. Odds ratio (OR) was calculated to assess the risk factors for severe cutaneous adverse drug reactions using SPSS 16. RESULTS: Total 124 cutaneous adverse drug reactions were reported with mean age 39.22 ± 20.47 years, male:female ratio being 1:1.4. Most common cutaneous adverse drug reaction was maculopapular rash. Antibiotics accounted for maximum cases, of which beta-lactams were the most common. About 55.6% cutaneous adverse drug reactions occurred within 24 hours of drug administration. Mean hospital stay duration was 4.89 ± 6.23 days. Most reactions were either mild or moderate. Risk analysis revealed that concomitant use of more than one drug, delayed onset, oral route, more generalized area of involvement and medications prescribed for CNS indications were risk factors for severe cutaneous adverse drug reactions. All reactions were preventable. Majority got fully recovered. No fatality was observed. CONCLUSION: Identification and reporting of cutaneous adverse drug reactions reduces their future occurrences and encourages rational prescribing. The study emphasizes on having a deeper understanding of risk factors for serious cutaneous adverse drug reactions that may contribute significantly in improving their outcomes.

Quetiapine-induced Diabetic Ketoacidosis.

Psychomotor retardation and extrapyramidal symptoms have limited the conventional antipsychotic use. Atypical antipsychotics though widely prescribed with good tolerability and efficacy, the metabolic complications associated with them are of clinical importance. Diabetic ketoacidosis (DKA) is a fatal complication of atypical antipsychotic use. We report a case of new-onset diabetes presenting as DKA with quetiapine use.

Comparative study of the toxicity of 5-fluorouracil-adriamycin-cyclophosphamide versus adriamycin-cyclophosphamide followed by paclitaxel in carcinoma breast.

CONTEXT: When cure is possible treatment should be undertaken despite life-threatening toxicities. Fluorouracil-Adriamycin-Cyclophosphamide (FAC) and Adriamycin-Cyclophosphamide (AC-P) are two popular regimens used in the treatment of carcinoma breast and the data regarding the toxicity profile of the AC-P regimen is scarce in the South Indian population. AIMS: To study the severity of different types of toxicities seen in patients on FAC and AC-P regimens, to grade the toxicity according to the World Health Organization (WHO) toxicity grading, and to compare the same. SETTINGS AND DESIGN: A prospective observational study, with 50 patients in each regimen, was conducted in the Department of Radiotherapy between February 2007 and July 2008. MATERIALS AND METHODS: The high risk patients received the AC-P regimen and the rest received the FAC regimen. The toxicities developed were graded according to the WHO guidelines. STATISTICAL ANALYSIS USED: The data was analyzed using the chi square test in SPSS 16. RESULTS: Anemia, hyperpigmentation, stomatitis, and diarrhea were significantly high (P < 0.05) in patients receiving the FAC regimen, whereas, leukopenia, myalgia, arthralgia and peripheral neuropathy were significantly high (P < 0.05) in patients receiving the AC-P regimen. The Karnofsky performance status was higher in patients receiving the AC-P regimen. CONCLUSIONS: Although both the regimens had different toxicity profiles the quality of life was better for patients on the AC-P regimen.