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Background: Cutaneous adverse drug reactions (CADRs) have been seen to be one of the most common adverse drug reactions in various studies, and the incidence in developing countries is thought to be higher between 2% and 5%. Moreover, severe CADRs (SCADRs) constitute 2% of all CADRS and can be life-threatening. The pediatric population too is vulnerable, and like in adults, SCADRs are associated with serious mortalities and morbidity; hence, early diagnosis and prompt treatment are the cornerstone for better survival. Objective: This study was undertaken to assess the patterns of SCARDs among pediatric patients and to identify the causative drug/drugs and establish causality using Naranjo scale and also study various treatments given including the role of corticosteroids in their management. Materials and Methods: A total of 52 pediatric patients (

Background: Acute generalized exanthematous pustulosis (AGEP) is a type of severe cutaneous adverse reaction that is characterized by the rapid development of nonfollicular, sterile pustules on an erythematous base. Objectives: The aim of our study was to enroll all cases of AGEP reporting to our department over a period of one year and to find out the clinical and etiological profile of the patients. Materials and Methods: All the patients reporting to our department with clinical features suggestive of AGEP were enrolled for the study. Careful history and examination were done to rule out other causes of pustular eruptions, which can resemble AGEP. AGEP validation score of the EuroSCAR study group was used to establish the diagnosis. Results: A total of 16 patients were enrolled during the study period of one year. The majority of the patients were females with a mean age of 28.41 ± 12.2 years. Twelve (75%) of the patients had a history of drug intake while 4 (25%) had developed AGEP following an insect bite. Penicillins were the causative factor in five patients followed by cephalosporins in three patients, nonsteroidal anti-inflammatory drugs (NSAIDs) in 2 patients, and terbinafine in 1 patient. Tetanus toxoid was responsible for the development of AGEP in one patient. The insect bites were all spider bites. Conclusion: AGEP is a rare type of severe cutaneous adverse drug reaction.We encountered 16 patients of AGEP over a period of one year. An important cause of AGEP was spider bite in our study group. [ABSTRACT FROM AUTHOR]

Background: Cefixime is a widely used third-generation cephalosporin schedule H1 drug, which is prescribed for the treatment of otitis media, respiratory tract infections, and uncomplicated urinary tract infections and is effective against infections caused by Enterobacteriaceae and Haemophilus influenzae species in India. The National Coordination Centre (NCC)-Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC), has received rare individual case safety reports (ICSRs) for acute generalized exanthematous pustulosis (AGEP) associated with the use of cefixime., Materials and Methods: IPC, NCC-PvPI also acts as a national collaborating center for pharmacovigilance activities under the aegis of Ministry of Health and Family Welfare, Government of India; moreover, it is a member country in global pharmacovigilance system, World Health Organization-Uppsala Monitoring Centre, Sweden. There are more than 250 government/corporate medical colleges and hospitals acting as regional adverse drug reaction monitoring centers, actively functioning under PvPI. Furthermore, various stakeholders including consumers and pharmaceutical industries also play a significant contribution. NCC-PvPI receives spontaneous ICSRs from various stakeholders., Results: NCC-PvPI, IPC has received a total of four spontaneous ICSRs for cefixime-induced AGEP. After clinical evaluation of reported ICSRs, a strong causal relationship was established between AGEP and cefixime and was supported by published literature and histopathological examination of skin. Based on the statistics with positive information component (IC025 Value: 0.17) and proportionality relative risk (PRR:3.4), PvPI considered cefixime-associated AGEP may be a potential signal., Conclusion: Hence, initially, AEGP is considered by PvPI as drug safety alert in July 2016. Therefore, to enhance the safety of population in rational usage of medication, as a result, there is a need for physicians and health-care professionals to sensitize about serious adverse reaction while prescribing the cefixime as signal in India., Competing Interests: There are no conflicts of interest.