Background:The epidemiological data based on intensive monitoring studies are limited for the cutaneous adverse drug reactions (CADRs) in terms of incidence. Most of earlier Indian studies focused only on types and causative drugs of CADRs.Aim:The aim of this study is to analyze the CADRs with reference to the incidence, its subgroup analysis, causative drugs, and other clinical characteristics in Indian population.Methodology:Intensive monitoring study was carried out over a period of 3 years in the dermatology outpatient and inpatient department. CADRs due to only systematically administered drugs were considered. The WHO definition for CADR, the WHO causality definitions, modified Schumock and Thornton's criteria for preventability, and International Conference on Harmonisation E2A guidelines for seriousness were considered. Incidence was expressed in percentage and its 95% confidence interval. The incidence was analyzed on basis of characteristics of study population and CADRs.Results:A total of 171 CADRs were observed from 37,623 patients. The CADR incidence was 0.45% (95% CI: 0.39–0.53). The incidence did not significantly differ in different age groups and gender. Commonly observed CADRs were maculopapular rash (23.98%), urticaria (21.64%), and fixed drug eruptions (FDEs) (18.13%). Antimicrobials (35.18%) and nonsteroidal anti-inflammatory drugs (NSAIDs) were suspected in all common CADRs. Anti-infective and NSAIDs were most commonly suspected drugs in overall CADRs, maculopapular rash, urticaria, FDEs, and erythema multiforme. The exact nature of drugs remained inaccessible in one-fourth cases due to use of the over-the-counter self-medications. The incidence of preventable and serious and fatal CADRs was 0.08% (95% CI: 0.05–0.11), 0.04% (95% CI: 0.02–0.06), and 0.003% (95% CI: 0.000–0.001), respectively.Conclusion:Ethnic characteristics should be considered while interpreting incidence from the international studies. The demographic characteristics of study population do not affect the incidence of CADRs. Indian patients should be sensitized about hazards of self-medications.

Background: Epidemiological data are limited regarding clinical characteristic of adverse drug reactions (ADRs) in India. Aim: The aim was to assess ADRs with reference to the causative drugs, seriousness and their other clinical characteristics in Indian tertiary care teaching hospital. Methods: A spontaneous reporting based ADR monitoring study was conducted over a period of 2 years. The World Health Organization (WHO) definition of an ADR and its seriousness was adopted. The organ system involvement was labeled by WHO-ADR terminology. ADRs were analyzed for causality by Naranjo's algorithm, preventability by modified Schumock and Thornton's criteria and types of reactions by Rawlins and Thompson classification. Subgroup analysis was performed between serious and non-serious reactions. Results: Of the total of 135 reactions reported 111 reactions from 97 patients were included for analysis. The incidences of overall and serious ADRs were 0.25 and 0.06 per 1000 patients, respectively. The most commonly implicated organ systems were skin and appendages (52.25%). The major causative drug classes were antimicrobials (40.28%), central nervous system (23.61%) and autacoids (15.97%). About twothirds of the reactions (65.77%) were classified as probable and one-tenth (8.10%) as preventable. The factors significantly associated with serious reactions were age group 40-60 years (odds ratio [OR]: 5.51), parenteral drugs (OR: 2.96), central and peripheral nervous system disorders (OR: 5.06), body as a whole -general disorders (OR: 9.05) and acute onset reactions (OR: 52.62). Conclusion: Antimicrobials are common causative agents. Cohort study is recommended to confirm the risk factors of serious ADRs in Indian population.

Context:Diabetes mellitus (DM) is the most common of the endocrine disorders. Mucocutaneous manifestations of diabetes mellitus are many and vary from trivial to life-threatening. Sometimes, mucocutaneous disorders may herald the onset of diabetes.Aims:To study the pattern of mucocutaneous manifestations in diabetics and role of it in diagnosing diabetes mellitus and its complications.Settings and Design:It was a longitudinal observational study of patients having diabetes with skin complaints attending skin outdoor department or admitted in wards for any reason in a tertiary care hospital.Materials and Methods:Total 300 patients were included in the study. Detailed history, clinical examination, and relevant investigations were done to diagnose the mucocutaneous disorders, diabetes, and diabetic complications.Statistical Analysis Used:The data was analyzed by using Epi info software.Results:Demographic profile shown majority of cases (78.66%) in more than 40 years of age with almost equal male and female preponderance. Mucocutaneous manifestations as presenting feature of diabetes were observed in 21.67% cases. Infections were most common in 119 (39.66%) cases, followed by acanthosis nigricans in 46 (15.33%) cases. Various associated complications like hypertension, retinopathy, hyperlipidemia, coronary artery disease, neuropathy, nephropathy, and diabetic ketoacidosis were observed in 160 (53.3%).Conclusions:Skin is the mirror, which reflects internal diseases; this aptly applies to skin and diabetes mellitus. Through awareness about cutaneous manifestations of DM, dermatologist can not only take credit for detecting DM but also facilitate early diagnosis of systemic complications of DM. This is immensely beneficial to patients in long run.

No abstract