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Cefixime is a third-generation cephalosporin that has been used for the treatment of a wide range of infections in children and adults. The incidence of cefixime induced toxic epidermal necrolysis (TEN) is less than 2% in adults, but it is infrequent among pediatric patients. We report a rare case of cefixime induced TEN in a 7-year-old boy. In this case, the child presented with symptoms of TEN after 2 days of administration of cefixime. This case highlights the need to select structurally different antibiotics in case of antibiotic-induced severe cutaneous adverse reaction (SCAR) to avoid recurrence of SCAR. Furthermore, concluded that irrational use of antibiotics could be disastrous as it can result in TEN as the incidence of antibiotics induced TEN ranges from 29% to 42%.

Background Each year nearly 10,000 children with thalassaemia major are born in India, but among them, very few are optimally managed mainly in urban regions even though the Government of India has incorporated their care and treatment in the 12th Five-Year Plan. Data on prescribing patterns and drug-related problems (DRPs) in paediatric thalassaemia patients in India are limited. Methods In this prospective interventional study, the medications prescribed were recorded after reviewing the treatment charts, thalassaemia register, thalassaemia card, nurses’ notes, as well as discharge summaries. When DRPs and/or medication errors were identified, the same was discussed with the concerned health care professionals and suitable suggestions were made at the earliest. Results Out of the enrolled 54 patients, only 94% (n = 51) of the patients received iron chelation therapy with deferasirox and/or deferiprone, Folic acid tablet was prescribed for 100% of the patients (n = 54). Five percent of patients (n = 3) had undergone splenectomy and was prescribed with amoxicillin prophylactically. There were a total of 16 DRPs and 15 medication errors were identified and suitable measurements were taken to solve these problems. Conclusions The prescribing patterns, DRPs and medication errors in transfusion-dependent paediatric thalassaemia patients were discussed in this study. Our study was effective in identifying and solving the DRPs and medication problems that occurred in thalassaemia patients.

Autoimmune hepatitis (AIH) is a non-contagious, chronic, inflammatory autoimmune disease in which one's own immune system attacks healthy, normal hepatic cells. The exact cause of AIH is unknown; however, the combination of genetic, environmental (eg, drugs and natural infection) and immunological factors may lead to AIH. AIH may also be potentiated with the use of vaccines: this case reports one such event following immunisation, along with 1 year of follow-up. A female patient in her late 20s presented to the hospital with yellowish discolouration of eyes, urine and stools. Her medical history revealed that she had been vaccinated with the first dose of a COVID-19 vaccine 10 days earlier. She had a history of asymptomatic COVID-19 infection 3 months ago and a history of chronic analgesic consumption for migraine. She was diagnosed as having AIH through extensive clinical and laboratory workup. This case may be an immediate enhancement of a hidden autoimmune disorder triggered by the vaccination. This adverse event following immunisation has an adequate temporal relationship with her COVID-19 vaccine. The causality can be categorised as 'indeterminate' and may be considered as a potential signal following COVID-19 vaccination.

Background: The COVID-19 vaccination program was introduced in India on 16 January 2021. The Government-issued fact sheet was the only source of information regarding Adverse Events Following Immunizations (AEFIs) for these vaccines. The objective of this study was to assess the AEFIs reported following COVID-19 vaccination in a tertiary care teaching hospital. Materials and methods: The spontaneous reporting method was used for data collection for a period of 3 months. A data collection form was designed to collect the data from the study population who reported adverse events. Collected data were analyzed and categorized by severity and seriousness. The causality assessment team performed causality assessment of the AEFIs using the World Health Organization’s causality assessment algorithm. Results: A total of 11,656 doses of COVID-19 vaccine were administered at the study site during the study period, of which 9292 doses were COVISHIELD™ and 2364 doses were COVAXIN™. In all, 445 AEFIs were reported from 269 subjects with an incidence rate of 3.48%. The majority of the subjects with AEFIs belonged to the age group of 18–45 years. Out of the total 445 AEFIs, 418 AEFIs were expected as per the fact sheets, 409 with COVISHIELD™ and 9 with COVAXIN™. Most of the AEFIs [62.02% ( n = 276)] were observed at the system organ class of ‘General disorders and administration site conditions’. After the causality assessment, out of 433 AEFIs to COVISHIELDTM vaccine, 94.22% ( n = 408) of events were categorized to have ‘consistent causal association with immunization’. Out of 12 adverse events following COVAXIN™, 8 (66.66%) events were categorized as ‘consistent causal association with immunization’. All of them recovered from their adverse events without any sequelae. Conclusion: Spontaneous reporting is one of the cheapest methods that can be used for the reporting of AEFI. This method helps health care professionals to identify rare events and potential signals.

Ayurveda is an indigenous system of medicine becoming more popular around the world in recent years. In various Ayurvedic formulations, the arsenical compounds are intentionally added as the main active ingredients or as an auxiliary agent to assist the efficacy of herbal drugs. The chronic arsenic poisoning following the use of Ayurvedic medication is reported rarely in the literature. This report describes a rare pediatric case of chronic arsenic poisoning from Ayurvedic medication in a 15-year-old girl. She was a known case of seizure disorder and was on treatment with Ayurvedic medication for 1 year. The generalized hyperpigmentation and thickening of soles were noticed in the girl 7 months after taking the herbal tablet. The plasma-coupled atomic absorption spectroscopy of herbal tablet was performed in a laboratory and the result showed 4.3 mg of arsenic present in each herbal tablet. The patient was advised to stop the Ayurvedic medication and as an alternate drug, tablet levetiracetam (250 mg, twice a day) was started for the treatment of seizure disorder. During the follow-up, her cutaneous manifestations improved and is doing well.

Background: India has almost 225 million adolescent girls and they seem to be at a disadvantage, both economically and by their lack of knowledge on human papilloma virus (HPV) vaccine, when compared to adolescent girls of other Asian countries. Aim: To assess the prevalence of HPV vaccination and to identify the impact of education in improving the knowledge and perception about the HPV infection and vaccination among the parents of adolescent girls. Methodology: The prospective interventional study was conducted in four schools within a South Indian City, Mysuru. The informed consent form and the questionnaire were sent home with the identified adolescent girls during the pre-interventional phase. Educational sessions were conducted for the students in their school and an education leaflet was distributed to their parents. Three weeks later, questionnaires were re-administered to the parents via the enrolled girls and their responses were collected. Results: The prevalence of HPV vaccination in the study population was 4.4%. There was a statistically significant improvement in knowledge in the post-interventional phase of the study ( p = 0.001), but could not identify a significant change in their perception ( p = 0.479). Parents belonging to the socioeconomic class of upper middle and upper lower showed better improvement at the end of the study, with a percentage improvement of 58.93% and 48.44%, respectively. Conclusion: The study proved that the healt care professional can target school children to communicate effectively to their parents on the importance of HPV vaccine as the study clearly observed a positive behavioral change among the study population.

Supplemental material, sj-pdf-1-tav-10.1177_2515135521990268 for Impact of indirect education on knowledge and perception on cervical cancer and its prevention among the parents of adolescent girls: an interventional school-based study by Rony Abraham Jacob, Priya Srambical Abraham, Feba Rachel Thomas, Vytila Navya, Juny Sebastian, Mandyam Dhati Ravi and Parthasarathi Gurumurthy in Therapeutic Advances in Vaccines and Immunotherapy

Supplemental material, sj-pdf-2-tav-10.1177_2515135521990268 for Impact of indirect education on knowledge and perception on cervical cancer and its prevention among the parents of adolescent girls: an interventional school-based study by Rony Abraham Jacob, Priya Srambical Abraham, Feba Rachel Thomas, Vytila Navya, Juny Sebastian, Mandyam Dhati Ravi and Parthasarathi Gurumurthy in Therapeutic Advances in Vaccines and Immunotherapy

Background Vaccination is considered as the most cost effective method for preventing infectious diseases. Low grade fever is a known adverse effect of vaccination. In India, it is a common clinical practice to prescribe paracetamol either prophylactically or therapeutically to manage fever. Some studies have shown that paracetamol interferes with antibody responses following immunization. This manuscript reports the outcome of a post hoc analysis of data from a clinical trial of a pentavalent vaccine in Indian infants where paracetamol was not used or was used either as prophylaxis or for treatment of fever. Methods Pre and post vaccine antibody levels against Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenzae type B were assessed in no paracetamol and paracetamol groups. The paracetamol group was further divided into prophylactic and treatment groups. Results Similar rates of seroprotection/seroresponse for anti-D, anti-T, anti-wP, anti-PT, anti-HBs and anti-PRP were observed in all the groups. There was no clear tendency for difference in percentage seroprotection/seroresponse and geometric mean (GM) titers in any of the groups. Conclusion The study found no evidence that paracetamol usage either as prophylactic or for treatment impact immunological responses to DTwP-HepB-Hib combination vaccine. [Clinical trial registry of India (study registration number CTRI/2012/08/002872 )].

Dapsone is extensively used for a variety of infectious, immunological, and hypersensitivity disorders. Dapsone can cause several adverse effects, the most serious being dapsone hypersensitivity syndrome (DHS), which is potentially fatal. DHS is characterized by triad of eruptions, fever, and organ involvement (including liver, kidney, hematological system, etc.). DHS can develop several weeks to as late as 6 months after treatment initiation with dapsone. Here, we report a case of DHS and leukemoid reaction with coexisting hepatitis E in a 10-year-old girl. Three weeks prior to the current admission, she was treated with dapsone (1 mg/kg/day in two divided doses) for 8 days by a local doctor for lichen nitidus. She was managed successfully for DHS with intravenous (IV) steroids followed by the oral steroid. This case is being reported to highlight the importance to ensure timely diagnosis of DHS and its appropriate management. Patients started on dapsone for various clinical conditions need to be observed carefully for the development of the DHS. If this occurs, DHS can be mistaken for the progression of the primary disease. If dapsone is not withdrawn, it could have deleterious and potentially fatal effects due to major organ dysfunction.

Fosphenytoin is used as an alternative phosphate ester prodrug to intravenous phenytoin for seizure treatment. Acute orofacial dyskinesia, secondary to phenytoin treatment is very uncommon. This case report gives the details of an 11-month-old baby girl, with post encephalitic sequelae, who developed orofacial dyskinesia during treatment with fosphenytoin. She was on fosphenytoin for the last 11 days. She presented with lip smacking movements on the 11th day of administration of fosphenytoin. At the time of presentation of orofacial dyskinesia, she found it difficult to keep her tongue inside her mouth and the involuntary movements subsided following the withdrawal of the drug. In this case, it was a probable cause of the relationship between the patient’s symptoms and the use of fosphenytoin according to the causality assessment scales such as the Naranjo scale and the World Health Organisation (WHO) Uppsala Monitoring Centre causality assessment system. She had a score of six. Also, the reaction is not likely to be owing to coexisting diseases or drugs. Though fosphenytoin induced orofacial dyskinesia is infrequent, there is a need to consider the adverse effects of fosphenytoin as a differential diagnosis in all patients with a movement disorder in the course of fosphenytoin treatment.

Pentavalent combination vaccines are important tools to strengthen the immunization programs in numerous countries throughout the world. A large number of countries have recognized the value of combination vaccines and have introduced whole cell pentavalent vaccines into their immunization programs. A phase III, multi-center, randomized, single blinded study of a fully liquid pentavalent DTwP-HepB-Hib investigational vaccine (Shan5™) was conducted across India in 2 cohorts: 15 toddlers were evaluated for safety and immunogenicity following a single booster dose (Cohort 1) followed by 1085 infants (Cohort 2) evaluated for immunogenicity and safety following 3-dose primary immunization of the investigational vaccine or a locally licensed comparator vaccine (Pentavac SD). Immune consistency analysis among 3 lots of the investigational vaccine, and immune non-inferiority analysis of pooled (3 lots) data of investigational vaccine vs. comparator vaccine were carried out in cohort 2. The vaccines demonstrated comparable safety and immune responses in cohort 1. In cohort 2, equivalent immune consistency among 3 lots was observed for all antigens except whole cell pertussis antigens, where a marginal variation was observed which was linked to the low power of the test and concluded to not have any clinical significance. Immune non-inferiority against the comparator vaccine was demonstrated for all 5 antigens. Safety results were comparable between vaccine groups. This investigational, fully-liquid, whole-cell pertussis (wP) containing new pentavalent vaccine was found to be safe and immunologically non-inferior to the licensed comparator vaccine.

Chronic iron overload in beta-thalassemia patients after continuous blood transfusions has caused notable morbidity and mortality in these patients. The once-a-day oral iron chelator, deferasirox has established efficacy and bearable safety in adults and pediatric thalassemia patients. It is now extensively used for the management of transfusional hemosiderosis. However, a number of studies have revealed a few patients continued to be none respondent or intolerant toward the once-a-day regimen of deferasirox even after the administration of maximum dose recommended by the World Health Organization. In the literature, there were three studies showing the boon of twice in a day dosing of deferasirox among transfusional-dependent beta thalassemia patients. Therefore, a nonsystematic review was conducted on above three studies to ascertain the enhanced effectiveness and tolerability of twice per day regimen of deferasirox with the same total dose as that of once daily regimen of deferasirox in unresponsive or intolerant transfusion-dependent beta-thalassemia (TDT) patients. All the above studies concluded that the twice per day regimen of deferasirox was more efficacious and tolerable among TDT patients when compared to the once-a-day regimen with the same total daily dose. Although there was a significant good results from these studies, there is a need to conduct either muticenter study or randomized control study in a larger number of patients for the better confirmation of the results as all the above studies were conducted in the small number of TDT patients.

Rotavirus is the leading cause of severe and dehydrating diarrhea in children aged under 5 years. We undertook this hospital-based surveillance study to examine the possible relationship between the severity of diarrhea and the various G-group rotaviruses circulating in India. Stool samples (n = 2,051) were systematically collected from 4,711 children aged

BackgroundRotavirus is the leading cause of severe, dehydrating diarrhea in children aged