BACKGROUND:Besides unparalleled benefits, highly active antiretroviral therapy is also associated with wide range of potential adverse drug reactions (ADRs), which hinders treatment adherence. The present study was thus designed to monitor and explore the pattern of occurrence of ADRs to various antiretroviral therapy (ART) regimens in a tertiary care ART setup.MATERIALS AND METHODS:A prospective, observational clinical study was carried out in the outpatient setting of nodal ART center of Eastern India. A total of 610 patients on various ART regimens were studied for suspected ADRs over 12 months. Adverse event history, medication history, and other relevant details were captured. Causality and severity of each reported ADR were duly assessed.RESULTS:32.45% patients of total study participants presented with a total of 330 ADRs. Patients from zidovudine-based regimens presented with majority of ADRs such as anemia (up to 36%), central nervous system (CNS), and gastrointestinal (GI) side effects. Tenofovir-based regimens were, however, found to be mildly safer. The combination with Efavirenz was associated with majorly CNS side effects while that of nevirapine was associated with rash and pigmentation of nails. Atazanavir boosted second-line regimens were notably associated with increased serum lipid levels followed by other GI and CNS adverse effects. Increased liver enzymes were found in atazanavir-based second-line ART.CONCLUSION:The study enables to obtain information on the incidence and pattern of ADRs associated with various antiretroviral regimens, thereby reducing its occurrence and protecting the patient population from avoidable harm. Need of intensive monitoring for ADRs in ARTs thus seems to be a mandate.
Cyclooxygenase inhibitors were developed in the quest of enhanced analgesic efficacy devoid of gastric side effects. High usage of etoricoxib by prescription as well as self-administered routes has led to increasing reports of side effects and adverse reactions including dermatologic reactions in 0.1%–0.3% of cases. The present report enumerates a case of toxic epidermal necrolysis induced by etoricoxib.
Oxcarbazepine is a closely related analogue of carbamazepine and is useful in the monotherapy of seizures with an improved toxicity profile. Its clinical safety has been recently put under scrutiny as evidence has emerged about its adverse drug reactions and it is increasingly being reported to cause cutaneous drug eruptions. Here we report a rare case of oxcarbazepine induced Stevens Johnson - toxic epidermal necrolysis overlap.
Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are the most Severe Cutaneous Adverse Reactions (SCARs) which mainly caused by exposure to drugs and having significant morbidity and mortality. TEN represents an immunologic reaction to a foreign antigen and is most often caused by drugs. Nevirapine (NVP), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is an important component of Highly Active Antiretroviral Therapy (HAART). It is sometimes associated with life-threatening adverse reactions. Here, we report the fatal case of 72-year-old male who developed TEN secondary to intake of nevirapine. This fatal case report will increase awareness among treating physicians for careful monitoring of patients on NNRTI-based antiretroviral therapy and better counseling of the patient on NVP regimen for early identification and reporting of SCARs so that fatalities due to adverse drug reactions can be prevented with timely intervention.
INTRODUCTIONWith the spurge of basic and clinical research activities, and the subsequent recognition of newer dermatological disorders; dermatology, venereology and leprology is now considered to be the one of the most important specialties in a healthcare setup. The skin, the largest organ of the body, epitomize for most of the underlying internal diseases. Dermatological conditions accounts for up to 2% of consultations in general practice worldwide. 1 Dermatological problem in India manifests as primary and secondary cutaneous complaints. 2 In India the most prevalent dermatological condition includes dermatitis ,
ABSTRACTBackground: Considering the economic burden the skin diseases cause owing to its high prevalence, it is of interest to periodically monitor the drug use pattern so as to increase the therapeutic efficacy, decrease adverse effects and provide feedback to prescribers. The present study thus assessed the drug use practices among dermatology outpatients in a tertiary care teaching unit in Eastern India.
Methods:The study assessed drug use practices for all prescriptions of patients attending the concerned OPD using WHO core drug use indicators which consist of mainly three domains, prescribing indicators, patient care indicators and healthcare indicators. Results: Total number of drugs in 471 prescriptions was found to be 1050. Number of drugs per prescription varied from 1 to 6 with average of 2.22. The most commonly prescribed drugs were antibiotics, followed by steroids and steroidal combinations. Prescribing indicators revealed that 2.09% drugs were generic prescribing, with about 18.78% of the drugs being prescribed from the WHO essential drug list. The proportion of encounters with at least one antibiotic prescribed was 34.82%. 13.9% drugs actually dispensed from hospital supply, of which all were adequately labelled. Conclusions: Increasing dermatological prescribing has necessitated assessment of their rational usage. Promoting rational drug use policy is recommended for effective healthcare management.
Background: Recently, the National Aids Control Organisation (NACO) in India advocated and recommended the use of tenofovir, lamivudine and efavirenz as a fixed-dose combination in initiating ART in all future treatment-naïve patients. The present study was thus undertaken to assess the nature and extent of safety concerns with this regime.Methods: A prospective observational study was carried out in the outpatient setting of nodal ART centre of Eastern India. A total of 242 patients on various ART regimens were studied for suspected ADRs over one year. Adverse event history, medication history and other relevant details were captured. Causality and severity of each reported ADR were duly assessed.Results: Out of 242 PLHIV put on this regimen, 75 patients did not encounter any adverse reactions during the entire study period. Out of remaining 167 patients who presented with a total of 451 ADRs, maximum ADRs were attributed to various psychiatric disorders which included insomnia, dizziness, drowsiness etc, which were followed by gastrointestinal disorders including anorexia, flatulence, nausea, vomiting etc. Dermatological complications included rashes, itching, SJS, pigmentation of nails, skin hyper pigmentation respectively.Conclusions: The study enables to obtain information on the pattern of adverse drug reactions associated with treatment naïve PLHIV put on first line antiretroviral regimen comprising of once daily dosing of tenofovir, lamivudine, efavirenz. Need of intensive monitoring for ADRs in ARTs followed with proper patient counselling regarding its nature can lead to better compliance to the therapy.
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