Toxic epidermal necrolysis induced by acetaminophen: a case report

Acetaminophen is a very commonly used analgesic and antipyretic drug across various age groups. Although mild to moderate cutaneous reactions have been reported quite frequently, serious reactions like Stevens –Johnson syndrome and Toxic epidermal necrolysis (TEN) are very rare. We report the case of a 10 year old child who had TEN after ingestion of tablet acetaminophen. This case report highlights the need to be critically aware of this rare and serious adverse effect of this commonly used over the counter drug

An evaluation of adverse drug reactions monitoring at a pharmacovigilance unit under pharmacovigilance program of India in a tertiary care hospital of Haryana

Background: Adverse drug reactions (ADRs) are among top 10 causes of mortality in patients. Pharmacovigilance programme of India (PvPI) is a step towards participation in the WHO programme for International Drug Safety Monitoring. The present article is an evaluation of the incidence and the patterns of ADRs from the reports collected from various clinical departments of this hospital.Methods: A total of 859 suspected ADR reports submitted to the pharmacovigilance unit at Department of Pharmacology under PvPI were evaluated for 6 months with respect to demographics, causative drug, organ system involvement, severity and seriousness of ADRs. The causality assessment was carried out by using WHO assessment method and Naranjo’s scale.Results: Males experienced more (66.33%) ADRs. The highest percentage (45.83%) of ADRs was seen in the age group of 46-60 years (35.33%), followed by 16-30 years (25.5%). The most common drug group causing ADRs was antimicrobials (43.37%), followed by anticancer and immunosuppressive agents (29.02%). The gastrointestinal system (31.43%) was most prone system, followed by generalized body reactions (22.93%) and cutaneous reactions (17.11%). 662 (77%) ADRs were non-serious, 197 (22.9%) were serious. On severity scale, 682 (79.39%) were mild, 168 (19.65%) moderate and only 9 (1.05%) ADRs were severe out of which three were fatal. As per WHO assessment method 66.94% ADRs were probable and 33.06% possible. The probability was comparable with Naranjo’s scale.Conclusion: ADRs to drugs happen commonly, and their reporting is important for the early recognition and prevention of ADRs and will also help in generating signals. ADR monitoring not only acts as an alerting mechanism for physicians, but helps the regulatory authorities in making the policy decision

Butterfly pattern hypopigmentation with antitubercular treatment

Standard short course chemotherapy is the key element of the DOTS strategy and these drugs cause different kinds of cutaneous adverse drug reactions that usually occur within 2 months of initiation of treatment in around 97% of the patients. We hereby report a case of a 16-year-old female patient who developed butterfly pattern hypopigmented rashes after 3 months of starting on category 1 antitubercular treatment (ATT). Other causes with similar picture were ruled out with additional investigations and the case was confirmed as ATT induced hypopigmented rash. WHO-UMC causality assessment showed a probable association

Cystic fibrosis: current treatment and future direction

Cystic fibrosis is an autosomal recessive genetic disorder, characterized by mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, leading to abnormality in the chloride channels of the mucus and sweat producing glands. Multiple organs systems are affected in this disorder, like respiratory system and gastrointestinal tract, severely impacting the patient’s quality of life, eventually leading on to several complications and death. Since the uncovering of the underlying genetic defect in cystic fibrosis (CF), our knowledge of the disease process has increased substantially, but we still lack a holistic approach to its management, which comprises of multiple facades, requiring both pharmacological and non-pharmacological or rehabilitatory approaches. So far, the therapeutic options were limited to targeting the consequences and complications of the disease, such as respiratory infection, mucus retention, pancreatic insufficiency, etc., but now several promising therapies may be able to address the underlying pathology rather than its long-term effects. This review summarizes the current and upcoming pharmacological options for CF, such as those targeting the CFTR gene defect directly, including gene editing, CFTR correctors and potentiators; drugs targeting the epithelial sodium channels (ENaC inhibitors); repositioning of some existing drugs and evaluating their role in CF; and understanding the disease better by transcriptomic approaches and the role of gut microbiota in the disease process and severity

Fatal case of ciprofloxacin-induced toxic epidermal necrolysis

Ciprofloxacin is a very commonly used antibiotic. Mild to moderate gastrointestinal side effects commonly reported whereas serious reactions such as Steven–Johnson syndrome and toxic epidermal necrolysis (TEN) are very rare. We report the fatal case of 25 years female who had TEN after ingestion of tablet ciprofloxacin. This case report highlights the need to be critically aware of this rare, but life-threatening side effect of this commonly prescribed antibiotic

The Availability of Essential Antimicrobials in Public and Private Sector Facilities: A Cross-Sectional Survey in a District of North India

(1) Background: There is a need to assess the availability of essential antimicrobials, as the availability of an antimicrobial is a critical element of its rational use. We aimed to assess the availability of antimicrobials listed in the National List of Essential Medicines 2015, India (primary list), and a selected (secondary) list comprised of agents indicated for commonly encountered infectious illnesses in various healthcare settings and to identify the reasons for their non-availability. (2) Methods: A cross-sectional survey of 25 public, private, and other sector pharmacies was carried out in Rohtak, a district of the North Indian state of Haryana, from April to June 2022. (3) Results: Most of the antimicrobials surveyed were optimally available in various sector pharmacies with the exception of benzathine benzylpenicillin, benzylpenicillin, cloxacillin, cefazolin, cefuroxime, cefadroxil, amphotericin B, and antimalarials. The most frequent reasons for limited availability were low demand, no prescriptions, and the non-listing of drugs in the state’s essential medicine list. (4) Conclusions: Enough evidence needs to be generated with respect to the status of availability of essential antimicrobials from different regions of India as well as other lower-middle-income countries to devise measures for ascertaining better availability of these agents, especially antibiotics at regional, national, and global scales

Sodium glucose co-transporter 2 inhibitors for glycemic control in type 2 diabetes mellitus: Quality of reporting of randomized controlled trials

Background: Sodium glucose co-transporter 2 inhibitors represent a novel class of antidiabetic drugs. The reporting quality of the trials evaluating the efficacy of these agents for glycemic control in type 2 diabetes mellitus has not been explored. Our aim was to assess the reporting quality of such randomized controlled trials (RCTs) and to identify the predictors of reporting quality. Materials and Methods: A systematic literature search was conducted for RCTs published till 12 June 2014. Two independent investigators carried out the searches and assessed the reporting quality on three parameters: Overall quality score (OQS) using Consolidated Standards of Reporting Trials (CONSORT) 2010 statement, Jadad score and intention to treat analysis. Inter-rater agreements were compared using Cohen's weighted kappa statistic. Multivariable linear regression analysis was used to identify the predictors. Results: Thirty-seven relevant RCTs were included in the present analysis. The median OQS was 17 with a range from 8 to 21. On Jadad scale, the median score was three with a range from 0 to 5. Complete details about allocation concealment and blinding were present in 21 and 10 studies respectively. Most studies lacked an elaborate discussion on trial limitations and generalizability. Among the factors identified as significantly associated with reporting quality were the publishing journal and region of conduct of RCT. Conclusions: The key methodological items remain poorly reported in most studies. Strategies like stricter adherence to CONSORT guidelines by journals, access to full trial protocols to gain valuable information and full collaboration among investigators and methodologists might prove helpful in improving the quality of published RCT reports

Causes of DMARD withdrawal following ADR within 6 months of initiation among Indian rheumatoid arthritis patients

The present study was conducted in Indian rheumatoid arthritis (RA) patients prescribed disease-modifying anti-rheumatic drugs (DMARDs) to determine the incidence and type of adverse drug reactions (ADRs) leading to their withdrawal in the initial 6 months of therapy. This was considered important as pharmacogenetic variations in the pattern of RA in different populations and genetic differences in efficacy and safety to drugs demand separate studies to be conducted in different populations. Hospital records were used to identify 1,000 consecutive patients with RA fulfilling the American College of Rheumatology criteria and having at least 6-month follow-up. Age, gender, duration of arthritis, drug usage and ADR-related drug withdrawal were recorded from the charts. Most of the patients were put on single DMARD. Combined use of DMARD was less frequent and non-use of DMARD was common; however, disease control was good. The commonest DMARD used in our hospital was hydroxychloroquine 444 (44%) and the commonest combination used was methotrexate with hydroxychloroquine by 55 (6%). Sulphasalazine use showed preference to young and males. Supportive drugs used were NSAIDs by 883 (88%), corticosteroids by 646 (65%), paracetamol by 594 (59%) and amitriptyline by 88 (9%). Incidence of ADR-related DMARD withdrawal was maximum with leflunomide 2/15 (13.33%) followed by methotrexate 9/116 (7.76%), sulphasalazine 6/185 (3.24%), chloroquine 3/131 (2.29%) and hydroxychloroquine 8/444 (1.8%). Severity and symptomatology of disease, genetic pattern of patients, financial status, previous experience of the clinicians and patients, availability of drugs, patient expectations and compliance were the main factors that lead to a difference in pattern of therapy in our patients compared to other population