Current Drug Safety - Volume 18, Issue 4, 2023

Vancomycin is considered the drug of choice against many Gram-positive bacterial infections. Therapeutic drug monitoring (TDM) is essential to achieve an optimum clinical response and avoid vancomycin-induced adverse reactions including nephrotoxicity. Although different studies are available on vancomycin TDM, still there are controversies regarding the selection among different pharmacokinetic parameters including trough concentration, the area under the curve to minimum inhibitory concentration ratio (AUC24h/MIC), AUC of intervals, elimination constant, and vancomycin clearance. In this review, different pharmacokinetic parameters for vancomycin TDM have been discussed along with corresponding advantages and disadvantages. Also, vancomycin pharmacokinetic assessments are discussed in patients with altered pharmacokinetic parameters including those with renal and/or hepatic failure, critically ill patients, patients with burn injuries, intravenous drug users, obese and morbidly obese patients, those with cancer, patients undergoing organ transplantation, and vancomycin administration during pregnancy and lactation. An individualized dosing regimen is required to guarantee the optimum therapeutic responses and minimize adverse reactions including acute kidney injury in these special groups of patients. According to the pharmacoeconomic data on vancomycin TDM, pharmacokinetic assessments would be cost-effective in patients with altered pharmacokinetics and are associated with shorter hospitalization period, faster clinical stability status, and shorter courses of inpatient vancomycin administration.

Preservatives are the ingredients that are utilized in order to improve the shelf life of products (Medicines, food). These tend to slow down or stop the degradation or decomposition processes, therefore, enhance the shelf life of the products. These agents either interfere with the chemical reaction or check the growth of microorganisms in the products. Preservatives are classified according to the mode of action or source or chemical nature. The preservation efficacy can be affected by various factors, e.g., interaction with other components, nature of preservatives, type of containers, type of micro-organism, and pH. Despite being vital for various types of products, these chemicals are not safe, if not used appropriately. The review will provide an updated detail of different types of preservatives along with their safety aspect. This review also highlighted the maximum safe concentration of preservatives that can be required to develop a formulation with maximum safety and low toxicity.

The drugs are projected to cure, prevent and treat diseases; however, there are also chances of mild or severe adverse drug reactions (ADRs) in the patients. Pharmacovigilance (PV) enhances the approach to safe medicines and healthcare, but integration into public healthcare remains a challenge in many countries. The Pharmacovigilance Programme of India (PvPI) is a nationwide programme launched by the Ministry of Health and Family Welfare (MoHFW), Government of India, on 14 July 2010. It is currently run by the Indian Pharmacopoeia Commission (IPC). Presently, 567 ADR Monitoring Centres (AMC) are functioning under PvPI across India. The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services (DGHS), and the Ministry of Health, Family & Welfare (MoHFW) Government of India is the National Regulatory Authority (NRA) of India. This review aims to trace the development of PV in India and its status among the top ADR reporting countries, with a focus on the current status of the studied ADR in different regions in India. Among the top 20 countries enthusiastic about sending ICSR per million population between 2015 and 2020, India shares 2% of the total ICSRs in VigiBase. India is now being recognized as a hub of global clinical trials and clinical research studies. Hence, it is the need of the hour in India to have a dynamic PV network system with an efficient and prudent operation method. Nevertheless, in India, PV programs are at an early stage on par with other countries, and only because of underreporting of ADRs. However, in the future, PvPI may appear as a big dashboard for ADR reporting culture in India as it continuously works hard to improve patients and drug safety.

Background: Marijuana, also known as cannabis, is the second most widely used illegal psychoactive substance smoked worldwide after tobacco, mainly due to the psychoactive effects induced by D-9-tetrahydrocannabinol (9-THC). Cannabidiol (CBD) is extracted from cannabis and may be used as an anti-inflammatory agent. Some patents on cannabidiol are discussed in this review. The cannabinoid is a non-psychoactive isomer of the more infamous tetrahydrocannabinol (THC); and is available in several administration modes, most known as CBD oil. Objectives: This study aims to provide an enhanced review of cannabidiol properties used in treating inflammation. This review also emphasises the current safety profile of cannabidiol. Methods: Cannabis is also called Marijuana. It is the second most commonly used illegal psychoactive substance in the universe after tobacco. D-9-tetrahydrocannabinol (9-THC) present in cannabis produces psychoactive effects. Cannabidiol (CBD) extracted from cannabis is used for antiinflammatory purposes. Cannabis smoking causes various types of cancer, such as lung, tongue, and jaw. The current review took literature from Google Scholar, PubMed, and Google Patents. Many clinical investigations are included in this review. Result: After analysing the literature on cannabis, it has been suggested that although cannabis is banned in some countries, it may be included in the treatment and mitigation of some diseases and symptoms like pain management, epilepsy, cancer, and anxiety disorder. Mild side effects were frequently observed in cannabis medications, which included infertility in females, liver damage, etc. Conclusion: Cannabis contains chemical compounds such as the cannabinoids delta-9- tetrahydrocannabinol (THC), a psychoactive substance, and non-psychoactive cannabidiol (CBD). Cannabidiol has been confirmed as an efficient treatment of epilepsy in several clinical trials, with one pure CBD product named Epidiolex. It is also used in treating anxiety and acne, as a pain reliever, and has anti-inflammatory properties.

Haemovigilance is the monitoring of the essential components of blood transfusion from its initial stages to the final outcome considering all the safety parameters and hazards that co-exist with it. It primarily aims to ensure the quality as well as safety related to the use of blood and blood products utilizing the standard healthcare framework and a tailored vigilance program for efficient outcomes. Initially, the art of vigilance was started with the therapeutic products available in the market giving some groundbreaking data on their safety which later led to the implementation of timely measures to control adverse events significantly. Several incidents have occurred during the collection, transport, storage, and transfusion of blood and to stop these incidences of hazard, haemovigilance came into existence with France becoming the first country to step in followed by several nations across the world with customized guidelines directing it to the best. The majorly reported problems include bacterial infections, hemolytic and immune reactions. The present writeup reviews the inception and development of haemovigilance programs with a global scenario, a detailed study of the haemovigilance program adopted in India, and the updated status of these programs in various countries across the globe.

Background: Ulcerative colitis (UC) is a chronic global disease, and its incidence and prevalence are increasing worldwide. Objective: Our objective was to compare the secondary outcome of treatment with Infliximab (IFX) and Adalimumab (ADA) in the UC patients. Methods: This was a one-year prospective observational study of moderate- to -severe UC patients treated with ADA or IFX. Patients' secondary health outcomes were measured using the EQ-5D 3L, EQ-VAS, and IBDQ-9 tools. T-test, Mann-Whitney, chi-square, and Fisher's exact tests were used to compare health-related quality of life (HRQoL) among UC patients. HRQoL predictor variables were identified by multivariate linear regression and multivariate logistic regression. Results: A total of 238 UC patients (patients taking IFX: 78, patients taking ADA: 160) with a mean age of 37.66 and a mean disease duration of 9.29 years were enrolled. The EQ-5D index, EQ-VAS, and IBDQ-9 scores of patients taking IFX were 0.65, 55.93 and, 37.42, respectively. Similarly, patients taking ADA were 0.68, 59.27 and, 36.61, respectively. The highest problem reports were in P/D: 86.1% and A/D: 73.5%. The main independent predictors of HRQoL were: education over 12 years (β = 0.054 [EQ-5D index], β = 13.63 [EQ-VAS], OR: 0.28 [MO], OR: 0.07 [SC]), education between 6-12 years (β = 11.23 [EQ-VAS]), and having "other chronic diseases" (β = -0.074 [EQ-5D index], β = -5.29 [IBDQ-9], OR: 2.84 [UA], OR: 3.80 [A/D]). Conclusion: There was no significant difference between the effect of ADA and IFX on secondary health outcomes in patients with moderate-to-severe UC.

Background: Febrile neutropenia is a prevalent oncologic complication. Initiating rapid treatment with empirical antimicrobials in febrile neutropenia patients reduces mortality due to infections. Objectives: The study aims to evaluate antimicrobial utilization among FN patients in Lebanon in terms of drug choice, dose, and duration of the treatment. This is a retrospective, multicenter, observational study conducted at three different Lebanese university hospitals (in which the Infectious Diseases Society of America (IDSA) guidelines are adopted), between February 2014 and May 2017. Methods: Adult cancer patients aged 18 years and older with febrile neutropenia were included in the study. Using the IDSA guidelines as a reference, patients were assessed whether they received the antimicrobial regimen inconsistent with the IDSA reference or not. Statistical analysis was performed using the Statistical Package for the Social Science software (SPSS version 22.0). The adherence to guidelines for the indication and doses of antibiotics and anti-fungal in patients with febrile neutropenia. Results: A total of 124 patients with a mean age of 54.43 ± 17.86 years were enrolled in the study. Leukemia (29.7%) was the most prevalent cancer and the most common infection was sepsis (20.2%). Combination antibiotic lactams are the most prescribed antibiotics (86.8%). Only 94 (86.23%) patients were given the antibiotic therapy appropriate for choice, dose, and duration. Empirical antifungal therapy was initiated in 63.7% of the patients and fluconazole was the most used antifungal (36.3%). In contrast to antibiotics, the majority of antifungal choices were not selected according to the recommendations and they were considered inappropriate for doses and the required treatment duration as proposed by (IDSA). Fifty-eight percent of patients received antivirals, even though it is not recommended as empirical treatment. Conclusion: In conclusion, this study reveals a non-consistent antimicrobial utilization practice at the involved sites concerning FN treatment. Inappropriateness was encountered in drug selection, dose, and duration of treatment with antifungals and antivirals.

Background: In traditional herbal medicine, the Coriandrum sativum (CS) seeds are widely used to prevent and/or treat several diseases. Despite this, research into studying their toxicity is very limited. Objective: This study aims at studying the acute and subacute toxicity of aqueous extract of coriander seeds (AECS) in Wistar rats. Methods: For acute toxicity, five dose levels (500, 1000, 2000, 3000, and 5000 mgkg^-1bw) were tested per single oral administration. Subacute toxicity for 28 days was achieved by daily oral administration of AECS at doses of 1000, 2000, and 3000 mgkg^-1bw. Results: No deaths or signs were recorded or observed in rats in the five groups and the control group was after 14 days of acute toxicity study. The results of subacute toxicity revealed that the administration of AECS caused a significant difference in the body weight of rats at doses of 2000 and 3000mgkg^-1bw, and in the development of movement disturbances, hypoactivity, drowsiness, weakness, and diarrhea, while histopathological examination showed vascular congestion and inflammation of the kidneys as well as hepatic necrosis. The haematological profile showed a significant increase in the number of red and white blood cells, haemoglobin, haematocrit, and a nonsignificant decrease is noticed in neutrophils at a dose of 3000 mgkg^-1bw. Conclusion: AECS should be used with caution as it has caused some signs of toxicity and may affect the liver and kidneys if doses are repeated. However, further studies are needed to verify and clarify the toxic aspect of Coriandrum sativum L. seeds.

Introduction: Brazil has been facing the pandemic of COVID-19 since march 2020. More than 540,000 people have died from this disease in the country. Some estimates indicate that the population exposed to SARS-CoV-2 represents 1 to 20%. However, these data are questionable due to the number of asymptomatic and untested individuals. As a result, vaccination for COVID- 19 has become the main means of achieving herd immunity. Objectives: To demonstrate, through local sampling, that broad and rapid vaccination may decrease the rate of COVID-19 detection in individuals potentially exposed to the SARS-CoV-2 virus. Methods: A total of 1,128 individuals were studied, including students and health professionals from Centro Universitário FMABC, who received the two doses of the vaccine for COVID-19 (Oxford/Astrazeneca ® and CoronaVac®). Results: In the studied period, there was a 41% reduction in the demand for RT-PCR tests after vaccination. And a 78.3% reduction in positive results after vaccination started. Conclusion: The results of this study showed that even vaccinating a population with higher exposure to the risk of contamination significantly reduced test positivity and the demand to perform these tests. This emphasizes that vaccination is the best strategy to achieve herd immunity and reduce the spread of the disease.

Background: COVISHIELD, ChAdOx1 nCoV- 19 Corona Virus Vaccine was granted emergency use authorization (EUA) as the first vaccine in India in January 2021. Knowing what to anticipate after vaccination will reduce vaccine hesitancy in the public. This study aimed to identify and measure the adverse events following COVID-19 vaccination. Materials and Methods: A cross-sectional observational study was conducted at Goa Medical College, starting on February 21 till May 23, 2021. A total of 418 people were enrolled. We collected the data using the Microsoft Form and analyzed using Microsoft Excel and R-program. Results: Of the 418 vaccine recipients, the incidence rate of AEFI (Adverse Events Following Immunization) was 54.31%. Fever, fatigue, and headache were the most commonly reported systemic AEFIs. Among these, 54.7% of AEFI were mild, 42.38% were of the moderate category, and only 2.96% were of grade 3 severity. None of the AEFIs were severe enough for hospitalization. Most of them developed symptoms within 24 hours of the first dose. Complete recovery from AEFIs took a median time of 24 hours. Conclusion: Most of our study findings were consistent with the phase 1, 2/3 trials findings of Oxford-AstraZeneca's ChAdOx1 vaccine. The AEFI symptoms were considered immune reactions to the vaccine. The AEFIs were more common among younger individuals and females. The chance of missing a serious adverse event like a thromboembolic phenomenon cannot be ruled out. We observed low AEFI rates with COVISHIELD in the Indian population compared to Oxford- AstraZeneca's ChAdOx1 vaccine in the UK-based population, which can be explained by preexisting immunity against adenovirus in the Indian population. However, based on the study findings, we may interpret that the COVISHIELD, Serum Institute of India, carries a good safety profile overall.

Objectives: Several factors influence medication patterns. The purpose of this study was to look into the role of social determinants in the use of prescribed and non-prescribed medications in a population-based setting of people over 18 in a southern metropolis of Iran (Shiraz) for 2 years. Study Design: Prospective population-based cross-sectional. Methods: This descriptive and cross-sectional survey was done in 2018-2020. A total of 1016 participants were randomly selected based on their postal codes and recruited to the study. The demographic characteristics (age, sex, and education), social profiles (insurance, supplementary insurance, health status, and daily exercise plan), and outpatient visits (family/general physician or specialist/ subspecialist) were recorded by gathering sheets. Descriptive analyses and multinomial logistic analyses were carried out using SPSS software. Results: The medication use pattern was classified into three categories: non-prescribed type I, non-prescribed type II, and prescribed. The mean age of participants was 45.54 ± 15.82 years. The results indicated that most of them took their medication without a prescription (non-prescribed type II). However, people who had insurance and referred to a family physician commonly used the prescribed medications. This study also found that patients who visited a family doctor or a general practitioner used fewer prescribed drugs than those who visited a specialist. Conclusion: This study describes social determinants as additional effective factors in health services that influence the use of prescribed and non-prescribed medications in Shiraz. These evidence- based findings can help policymakers to plan the best programs.

Background: Asthma is a chronic inflammatory disease of the small airways. Chronic inflammation often causes hyper responsiveness of airways with wheezing, breathing difficulty, cough and chest tightness. Objective: The present study aimed to evaluate the drug usage pattern of anti-asthma drugs among asthma patients. Methods: The present study was a prospective, observational cross-sectional study carried out among 422 outpatients being treated at the respiratory medicine department, SRM Medical College Hospital and Research Centre. Data regarding the prescribing indicators and patient indicators were collected from the patients' prescription slips and entered in the preformed proforma. Prescribing indicators were taken into consideration in evaluating the rationality of prescriptions. Results: In the present study, 49% of patients were between the age group of 20-40 years. Genderwise distribution showed 58.05% of males and 41.95% of females. A family history of asthma was seen in 68% of the study population. The present study reported smoking among 51% and tobacco chewing in 21% of the study population. Low economic strata were observed in 77.9% of the study population. According to asthma grading, 65.8% were in the mild intermittent, and 25% were in the mild persistent group. Patients were on β2 agonists (35.4%) and corticosteroids (32%). The most commonly used fixed drug combination was a short-acting β2 agonist with corticosteroid (40.5%). A total of 68% of drugs were used by the inhalational route and 29% by the oral route. Conclusion: The findings showed that, the most frequently prescribed drug was a short-acting β2 agonist with corticosteroid in a fixed-dose combination via inhalational route.

Background: Considering the dearth of research on the complications of Sinopharm coronavirus disease 2019 (COVID-19) vaccine in immunocompromised individuals and the lack of available data on COVID-19 vaccination from Iran. Objective: This study aimed to investigate the efficacy of vaccine of Sinopharm COVID-19 vaccine and its complications in bone marrow transplant (BMT) recipients. ; Methods: This was a retrospective cross-sectional study conducted on 250 patients with BMT who were referred to Montaserieh Hospital, Mashhad, Iran. Among them, 53 cases who received at least two doses of Sinopharm COVID-19 vaccine from March to January 2021 were entered in this study. The data were extracted from a student dissertation (Code:4000370). Results: Sinopharm vaccine side effects were reported only in 7.7% of the patients, and shingles was the only serious side effect of the Sinopharm vaccine, which was observed only in one case. The results also revealed that Sinopharm COVID-19 vaccine side effects were not related to age or gender. Infection with the Delta variant of COVID-19 was reported in 7.5% (n=4) and no mortality was reported among them. Vaccine failure was reported in 39.6% of the cases; however, no mortality was reported among patients infected with the Omicron variant of COVID-19. Conclusion: In summary, it seems that Sinopharm COVID-19 vaccine adverse effects were not serious among stem cell transplant recipients. However, it may lead to some severe complications in the population. Vaccine failure against the Delta and Omicron variants of COVID-19 has been reported among more than one-third of BMT patients; however, no mortality was observed among BMT patients infected with the new variants of COVID-19.

Background: Warfarin (WAR) is an anticoagulant with a narrow therapeutic index and is principally metabolized by CYP3A4 and CYP2C9 enzymes. The inhibitors of these enzymes may alter the systemic exposure to WAR. Quercetin (QUE), a bioflavonoid, may modify the bioavailability of drugs used concurrently by inhibiting CYP3A4, CYP2C8, CYP2C9, CYP1A2, and Pglycoprotein (P-gp). Objective: The current study scrutinized the influence of QUE on WAR pharmacokinetics in rats. Method: QUE was orally administered to animals for 14 consecutive days, followed by WAR as a single oral dose on the 15^th day in the pre-treatment group. The co-administration group received a single dose of QUE and WAR concomitantly. Only carboxymethylcellulose (CMC) 0.5% was administered as a vehicle to control group. Results: In the pre-treated group, WAR’s Cmax was increased by 30.43%, AUC0-∞ by 62.94%, and t1/2 by 10.54%, while Cl decreased by 41.35%, relative to control. In co-administered animals, WAR’s Cmax increased by 10.98%, AUC0-∞ by 20.20%, and t1/2 by 8.87%, while Cl declined by 16.40%. Conclusion: QUE alters the pharmacokinetics of WAR, warranting possibly WAR dose adjustment after confirmatory clinical investigations, specifically in patients with thrombotic disorders and a pre-treatment history of QUE or its product.

Background: Ischemic stroke accounts for around 87% of all strokes worldwide and is the second leading cause of mortality and a significant factor of disability in adults. The objective of this study was to assess the adherence to international treatment guidelines for ischemic stroke in Lebanese hospitals and evaluate factors associated with in-hospital mortality. Methods: This retrospective observational study was conducted in three Lebanese hospitals between January 2018 and December 2019. All adult patients diagnosed with ischemic stroke and who were subsequently admitted and treated in the internal medicine department, intensive care unit, or coronary care units were included in the study. Results: Out of 292 patients with stroke, 56.8% were females with hypertension being the most common previous disease (38.4%). Concerning acute management, 94.5% had an early brain imaging performed upon hospital presentation, 14.4% were eligible for emergency reperfusion, 2.1% were prescribed fibrinolytic therapy, 50% were adherent with acute hypertension treatment, and 6.2% were adherent with the antiplatelet regimen recommendation. The results highlight that right sided hemiparesis, decreased level of consciousness, and hyperthermia (T > 38°C) were significantly associated with in-hospital death. Guideline adherence for all the acute treatment measures and management strategies was 90.2%. Conclusion: The study highlights that guideline recommendations were not uniformly applied among all patients, and those recommendation standards set by the guidelines were not applied among all hospitals.

Introduction: β-lactam antibiotics, mainly cephalosporins, and carbapenems, have been the mainstay of treatment for infections caused by Enterobacterales. However, their role in treating clinical infections has become limited because of the increase in resistance. There is a need to have cost-effective and rapid methods for antimicrobial susceptibility testing methods for newer antibiotics like ceftazidime-avibactam against carbapenem-resistant Enterobacterales (CRE), which can be applied in routine clinical microbiology laboratories. With this aim, the present study was conducted to compare the disk diffusion and gradient diffusion, i.e., the E-test method with the reference broth microdilution (BMD) method for in-vitro testing of ceftazidime-avibactam against CRE. Materials and Methods: A total of 111 CRE isolates from various clinical samples were included. Conventional PCR (Polymerase Chain Reaction) was done for the detection of genes encoding carbapenemases and to see their expression, modified carbapenem inactivation method (mCIM) along with EDTA (Ethylenediaminetetraacetic acid) carbapenem inactivation method (eCIM) was done. Results: 42.3% (47/111) isolates were resistant to ceftazidime-avibactam by the standard broth microdilution method; however, 45.9% (51/111) were resistant by both disk diffusion and E-test. In 5.4% of isolates (similar in both methods), microbroth dilution method results did not match with E-strip and disk diffusion. Very major errors (VME) by both disk diffusion and E-test were found in 2.1% (1/47), and major errors (ME) were found in 7.8% (5/64) isolates (similar isolates in both methods). The overall categorical agreement (CA) rate was 94.6% for both E-test and disk diffusion, and the essential agreement (EA) rate was 90.1% (100/111) for E-test. 98% (109/111) of CRE harbored carbapenemase genes either singly (30.3%) or in combination with others (69.7%). Conclusion: In conclusion, for CRE, E-test and the disk diffusion method for ceftazidimeavibactam depicted an acceptable performance as an alternative to the reference broth microdilution method.

Introduction/background: Drug reaction with eosinophilia and systemic symptoms reaction (DRESS) syndrome is a serious, potentially life-threatening drug side effect associated with more and more drugs. However, antipsychotics have rarely been involved in such condition. Case Report: We report here a suspected case of chlorpromazine induced DRESS syndrome in a 33-year-old woman with a history of allergic rhinitis and bipolar disorder who has reported an unexplored generalized skin eruption after taking chlorpromazine 10 years before. Only 24 hours after starting the therapy, the patient developed erythematous skin eruption on her limbs and her trunk with biological abnormalities, including liver enzyme elevation and eosinophilia. Skin eruption disappeared spontaneously within 3 days after therapy discontinuation and subsequently, biological abnormalities regressed. Patch tests were performed and were positive for chlorpromazine. At same time, we performed a literature review of the DRESS syndrome induced by antipsychotics. No patch tests were performed for those cases. Conclusion: Clinicians should be aware of such clinical features after starting patients on antipsychotics to withdraw the culprit drug as early as possible and avoid further complications.

Background: Drug-induced hypersensitivity reaction is a potentially life-threatening condition reported among patients of different age groups. Phenytoin is a prototypic drug prescribed for the treatment of a variety of seizure disorders. Allergic reaction to phenytoin therapy in a newborn is relatively a rare clinical manifestation that is not frequently reported. Objective: The objective of this study is to report a suspected case of hypersensitivity reaction in a newborn possibly due to phenytoin and the strategies to prevent these immune-mediated reactions. Case Report: An early term newborn on the 4^th day of life developed erythematous rashes over the abdominal region following phenytoin treatment for recurrent generalized tonic-clonic seizures. Prenatal history was uneventful except for the mother had preeclampsia during the third trimester of pregnancy. The suspected phenytoin was replaced with phenobarbitone to control seizure episodes. Subsequently, the rashes disappeared. The baby had also suffered from skin discolouration after phototherapy. Radiological investigations and cerebrospinal fluid culture were performed to detect the etiology of seizures. Conclusion: Hypersensitivity reaction to phenytoin in newborns is a rare clinical entity but may lead to serious lethal complications. Thus, stringent clinical monitoring of patients on phenytoin therapy is mandatory, especially in the pediatric population.

Background: Methotrexate is an antimetabolite anticancer drug frequently used in the treatment of extensive chronic plaque psoriasis. Psoriasis patients on treatment with immunosuppressants have an increased risk of developing malignancies. Objective: To present a rare case of Oral Squamous Cell Carcinoma (OSCC) in a psoriasis patient postacute methotrexate toxicity. Case Report: A 47-year-old female, a known case of chronic plaque psoriasis for which she was on 15 mg/ week methotrexate therapy and accidentally consumed 15 mg for 7 consecutive days. She was successfully treated for methotrexate toxicity and 45 days later she presented with exophytic growth on the tongue. Histopathology confirmed the diagnosis of squamous cell carcinoma and the patient underwent surgical resection. Conclusion: There could be a causal association between psoriasis and OSCC in the setting of acute methotrexate toxicity, as in the present case.

Background: There have been increasing reported cases of new-onset or aggravation of pre-existing dermatoses after the implementation of COVID-19 vaccination. Case Presentation: An elderly male was presented with multiple annular scaly plaques all over the body two weeks following administration of the first dose of Oxford-AstraZeneca COVID-19 vaccine. The lesions further aggravated after taking the second dose of the vaccine. The clinical and histopathology features were suggestive of annular plaque psoriasis. Conclusion: We report this first case of de novo plaque psoriasis following the Oxford- AstraZeneca COVID-19 vaccine, and it signifies a potential side effect of autoimmune reactivation after COVID vaccination.