Cutaneous Adverse Drug Reactions Research Articles

Cutaneous adverse drug reactions

Background: Cutaneous adverse drug reactions are common and produce easily identifiable clinical symptoms. These may range from mild maculopapular rashes to severe reactions associated with systemic disease.Current Concepts: The most common presentation of a drug eruption is in the form of a maculopapular rash or exanthematous skin eruption, followed by fixed drug eruptions and urticaria. Severe cutaneous adverse drug reactions include Stevens-Johnson syndrome/toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms, which are rare but potentially life-threatening. Recently, it has emerged that cutaneous adverse drug reactions associated with newly developed drugs, such as epidermal growth factor receptor inhibitors, may induce a variety of cutaneous manifestations.Discussion and Conclusion: Although certain drugs, such as antimicrobials and anticonvulsants, can frequently cause drug eruptions, their effects may change, depending on the situation and timing. Therefore, in order to resolve symptoms and prevent complications, early diagnosis, drug identification, and appropriate treatment should be performed, in consideration of the various factors involved.

Saline Vehicle Increases the Ability of Drug Patch Test in Cutaneous Adverse Drug Reactions

Background: Drug patch test to identify cutaneous adverse drug reactions (CADRs) has been widely reported. Appropriate vehicles can improve the ability of drug delivery and significantly increase positive reaction of drug patch tests. Objective: The aim of this study was to evaluate the efficacy of drug patch tests using 0.9% saline vehicle in comparison with other traditional vehicles in CADRs. Method: All patients were patch tested with suspected drugs using 10–30% concentration of the commercialized form of drugs diluted in 0.9% saline, petrolatum, and water. Result: Of 100 patients with CADRs, 54 of those had at least one positive drug patch test. In terms of vehicles used, 43 patients had positive drug patch test with saline as compared to 35 with water (p = 0.485) and 25 with petrolatum (p = 0.007). Among CADRs subgroup, saline rendered significantly higher positive rate when compared with petrolatum in drug rash with eosinophilia and systemic symptom (DRESS) (70% vs. 20%, p = 0.025), maculopapular rash (MP) (52.4% vs. 31%, p = 0.046), and lichenoid drug eruption (46.7% vs. 0.0%, p = 0.002). 12/54 (22.2%) of CADRs patients had positive reaction with saline alone. Among these patients, 4/12 (33.3%) were lichenoid drug reaction, 3/12 (25%) were DRESS, and 2/12 (16.7%) were MP rash. Allopurinol was the drug giving positive patch test only with saline. Conclusion: Appropriate vehicles are essential to obtain the positive drug patch test. Using saline as a vehicle can increase the positive reaction of drug patch test, particularly in lichenoid drug eruption. We recommend the use of saline as another traditional vehicle in drug patch test.

Retrospective study on cutaneous adverse drug reactions in a tertiary care center

Background: Cutaneous adverse drug reactions (CADRs) range from mild-to-severe types and occasionally can become fatal. Hence, these incur additional financial burden both to patients and community. Aim and Objective: The aim of the study was to describe the characteristics of CADRs reported to ADR monitoring center (AMC) of a tertiary care center. Materials and Methods: CADRs reported to the AMC over a period of 2 ½ years were retrospectively studied. This study mainly focused on affected age group, gender, various pattern of CADRs, the group and name of drugs causing CADRs, and severity and causality assessment. Results: CADRs contributed 31.6% of the total ADRs reported to the AMC. Among these, 51.7% were females and 40% were of 51–60 years age group. About 37.9% of CADRs were pruritus. Antibacterial drugs were the most common cause of CADRs and beta-lactam antibiotics were responsible for 30% of CADRs. Stevens Johnson syndrome (SJS) constituted 4.9% of CADRs and 20% of this was due to Paracetamol. Drugs were withdrawn in 89% of cases and 85% cases recovered. On causality assessment, 94% were of probable category. Conclusion: Pruritus was the most commonly observed CADR and antibacterial drugs were the most common cause. Beta lactam antibiotic was the most frequent antibacterial drug to cause CADRs. The most common serious CADR was SJS and Paracetamol was the most frequent culprit drug.

Pattern of cutaneous adverse drug reactions in an adverse drug monitoring center at a tertiary care hospital in Kerala

Background: Pre-marketing clinical trials can filter only about 50% of the drug reaction. Hence, to prevent the morbidity and mortality due to severe cutaneous reactions early detection, evaluation and monitoring of adverse drug reaction (ADR) especially cutaneous ADR (CADR) are mandatory. Hence, it is imperative that we update our knowledge of the precise nature of ADR which will prevent the reactions as well as to find the offending drug. Aim and Objectives: The aim of the study was to evaluate the pattern of CADR, the suspected drugs and to perform the causality assessment using WHO casualty assessment scale. Materials and Methods: A retrospective descriptive study was done using the data reported to ADR monitoring center in the Department of Pharmacology by the health-care professionals. Suspected CADR was diagnosed by the consultants concerned. The CADRs collected were categorized according to their morphology into maculopapupar rash (MPR), fixed drug eruptions (FDE), urticaria, Stevens-Johnson syndrome, and toxic epidermal necrolysis. The causality assessment was done using WHO Causality assessment scale. Results: The mean age was 47.20 + 22.31. The most common CADR reported was Urticaria 65.5% followed MPR 23%, FDE 8.8%, and Steven Johnsons Syndrome 2.2%. Anti-microbial drugs were the most frequent cause of the adverse reactions with Amoxicillin clavulinic acid combination being the most frequent suspected drug producing CADR (13.3%). The WHO causality assessment for majority of CADR was Possible (73.5%). Conclusion: Clinical Patterns of CADRs in this set up have some minor variations when compared to studies done across India. Amoxicillin clavulinic acid is the most common suspected drug in this study which was not frequently reported in other ADR monitoring centers.

A study of cutaneous adverse drug reactions in a tertiary care hospital

Background: Cutaneous reactions are the most common types of adverse drug reactions (ADRs). Drugs administered systemically are the important causes of cutaneous ADRs (CADRs). The physicians should be familiar with these CADRs so that it would help in early recognition and prompt withdrawal of drug. For this, a good knowledge about the pattern, frequency, and causative agents of dermatological adverse reactions in our hospital is needed. Aims and Objectives: This study was done to reveal the pattern, frequency, and most common drugs causing dermatological ADRs in our institution. There is no such study done about the CADRs reported in our institution; so far, hence, this study was done. Materials and Methods: In this study, the CADRs identified and reported by the dermatologist in the dermatology out-patient department as well in patients admitted in the dermatology ward were studied. Results: The common CADRs were urticaria 42.3%, erythematous lesions 34.6%, Stevens–Johnson syndrome 15.3%, hyperpigmentation 7%, and maculopapular rash 7%. Among the different groups of drugs, antibiotics is at the top of the list with 31.3%, followed by antitubercular drugs 24.2%, antiretroviral drugs 21.3%, antiepileptic drugs 10%, and other miscellaneous drugs. Conclusion: Early recognition of various CADRs is essential so that the offending drug is recognized and stopped immediately. This can also help in prevention of ADRs.

Cutaneous drug reaction secondary to antitubercular regimen: A case report from Nepal

Cutaneous adverse drug reactions are known side effects of first-line antitubercular therapy, which ranges from mild pruritus to life-threatening toxic epidermal necrolysis. Severe cutaneous adverse drug reactions can lead to antitubercular therapy discontinuation and further complicates tuberculosis treatment. Here we present the case of a 49-year-old obese male who developed a generalized maculopapular rash within 24 hours of initiation of therapy followed by bullae over palms in 3 days. Antitubercular therapy was immediately discontinued, and he was managed with antihistamines, intravenous fluid, and electrolyte supplementation. He was discharged on antihistamines, a short course of systemic steroids, moxifloxacin, and bedaquiline (second-line antitubercular therapy (ATT)). Proper guidelines about rechallenge therapy will enormously aid in managing cutaneous adverse drug reactions, and efficient treatment of tuberculosis in these patients, and ceasing its progression to multisystemic complications. This article aims to discuss the presentation and management of cutaneous adverse drug reactions in the setting of Nepal.

Adverse Cutaneous Drug Reactions at a Rural-Based Tertiary Health-Care Center in Gujarat: An Eleven Year Study.

An adverse cutaneous drug reaction (ACDR) is an undesirable change in structure and function of the skin, its appendages, or mucous membranes due to drugs. To study the demographic details, clinical patterns, mucocutaneous involvement, causality, and the offending drugs causing ACDR. In this observational study, we have seen 2,96,544 patients in the skin department at a rural-based tertiary health-care hospital, out of which 728 cases were diagnosed to have ACDR from a time span of April 2010 to March 2021. The causality assessment system WHO-UMC (World Health Organization Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre), the Naranjo probability scale, and Hartwigs score were calculated for patients. Out of 728 cases, males were 371 (50.96%); most common age group was 21-30 years (25.13%). The most common presenting complaint was erythematous rash (21.29%). Antimicrobials (n = 345, 47.39%) were the most common drug group. Most common mucosa involved was oral mucosa and most common pattern of reaction seen was maculopapular rash (25%) among these patients. In the causality assessment using WHO guidelines, there were 66 (9.1%) certain, 224 (30.83%) probable, and 436 (60%) possible cases. Naranjo score showed 73 (10%) definite cases, 255 (35%) probable cases, and 400 (55%) possible cases, while Hartwigs score showed level 2 in 122 (16.7%) cases and level 3 in 412 (56.7%) cases. Wide spectrum of drug reactions were observed in this study. Antimicrobials were the most common causative agents of ACDR.

Cutaneous adverse drug reactions in a tertiary care setup: A cross-sectional observational single-center-based study in Eastern India

Background: Cutaneous adverse drug reactions (cADRs) constitute a significant cause of mortality and morbidity, adding to the economic burden for the patients. cADRs have varied and diverse presentations of morphology and severity. The present study aimed to explore the spectrum of cADRs reported in a tertiary care setup in Eastern India. Methods: A cross-sectional, single-center-based observational study was undertaken which included all the patients reporting with suspected cADRs. The patient details, ADR characteristics, and other relevant details were noted. Detailed pharmacovigilance workup, including causality, severity, and preventability assessment, was performed. Data were statistically analyzed. Results: 0.16% incidence of cADRs was observed, with the most common form being urticaria, followed by fixed drug eruption, maculopapular rash, and erythroderma. The most common drug class suspected to cause cADR was antimicrobials, followed by corticosteroids and nonsteroidal anti-inflammatory drugs. While most reactions were of moderate grade in severity, majority of the reactions were under “possible” causal category. 22.1% of the reported cADRs were not preventable. Conclusion: Proper diagnosis and optimum management of cutaneous ADRs are critically challenging and important.

Clinicoepidemiological study of adverse cutaneous drug reactions among immunocompromised children at a tertiary care hospital.

Highly active antiretroviral therapy (HAART) is used to treat human immunodeficiency virus type 1 (HIV-1). Introduction of antiretroviral therapy (ART) has reduced the HIV/AIDS associated morbidity and mortality significantly. But 25% of all patients discontinue treatment because of adverse drug reactions (ADRs). Adverse cutaneous drug reactions (ACDR) are very common with ART regimens, which may range from mild pruritus, maculopapular rash to serious Steven Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). ACDRs comprise 10%-30% of all reported ADRs. To assess the different types of cutaneous adverse drug reactions in immunocompromised children of less than 18years. This is a retrospective record-based study, conducted at department of Dermatology, Venereology and Leprosy, Government Medical College (GMC)/Government General Hospital (GGH), Suryapet, Telangana, India. Data was collected from the records available at ART centre, from November 2018 to October 2021 GGH, Suryapet. All the HIV infected children ≤18 years who were on ART, were included in this study. Patients of more than 18 years and on other medications were excluded. Demographic data, socio economic status, vaccination status, height, weight, complete blood analysis, complete urine analysis, erythrocyte sedimentation rate, liver and renal function tests and CD4 counts were recorded before initiation of ART. A total of 330 children of less than 18 years were initiated for ART, at ART centre, Government General Hospital, Suraypet. Out of 330 children, 27.8% (92) children developed ACDRs. 58.7% (54) were males and 41.3% (38) were females. Maculopapular rash was seen in 65.2% (60) cases, urticaria was seen in 15.3% (14) cases, Steven Johnson Syndrome (SJS) was seen in 9.8% (9) cases, SJS/TEN overlap was seen in 6.5% (6) cases and toxic epidermal necrolysis (TEN) was seen in 3.2% (3) case. CD4 count was below 300 in 65.3% (60) cases above 300 in 34.7% (32) cases. Gap between initiation of the treatment and onset of reaction was less than one month in 65.3% (60) cases, and more than one month in 34.7% (32) cases.

Dermatological adverse drug reactions with particular reference to Steven-Johnson syndrome and toxic epidermal necrolysis

Background: Drug therapy is an inevitable cause of cutaneous adverse reactions. Aims and Objectives: The primary aim was to identify the incidence and magnitude of various dermatological adverse reactions including Steven-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Moreover, secondary aim was to quantify the risks associated with the use of specific medications. Materials and Methods: A prospective and hospital-based study was conducted in the department of dermatology SMHS hospital on hospitalized cases of cutaneous adverse drug reactions (CADRs). Informed consent was sought and reactions were reported on validated questionnaire based on adverse drug reaction (ADR) monitoring form provided by Central Drug Standard Control organization Ministry of Health and Family Welfare, Government of India. These dermatological reactions were assessed for the clinical pattern, causative agents, and prognosis. The WHO-Uppsala Monitoring centre system for standardized case was used for causality assessment of all cases identified. Results: A total of 101 hospitalized patients with varied dermatological ADRs were reported during the study period. Cases were found more in females (n=75, 74.25%) than in males (n=26, 25.75%). CADRs that were reported in our study were exanthematous rash, fixed drug eruptions, urticarial rashes, SJS, TEN, urticarial vasculitis, anticonvulsant hypersensitivity syndrome, erythema multiforme, contact dermatitis, exfoliative dermatitis, mucosal hyperpigmentation, and nail pigmentation, respectively. After a meticulous drug history, the drugs implicated in causing the cutaneous reactions were anticonvalscents such as phenytoin, carbamazepine, lamotrigine, and phenobarbitone. Other drugs identified were non-steroidal anti-inflammatory drugs such as oxicam, antibiotics such as sulfasalazine, cefixime, cefpodoxime, amoxicillin, fluoroquinolones such as levofloxacin and ciprofloxacin, chemotherapeutic agents such as cyclophosphamide, 5FU, and hydroxurea. Conclusion: The present study concluded that skin is most common target for ADRs. Drug-induced cutaneous reactions can be as simple as a mild rash to rare life-threatening SJS and TEN. Moreover, certain group of patients is at increased risk for developing CADR’s as women are more susceptible than men.

Serum interleukin-21 level in patients with severe adverse cutaneous drug reactions and correlation with disease severity

IntroductionInterleukin-21 (IL-21) is accepted to play a pathogenic part in development of unfavorable cutaneous medicate responses. Adverse cutaneous drug reactions create a wide run of clinical signs such as pruritus, maculopapular ejections, urticaria, angioedema, fixed drug eruption, erythema multiforme, vesiculobullous responses (e.g. Stevens–Johnson syndrome and toxic epidermal necrolysis), and exfoliative dermatitis.Patients and methodsTwenty patients (drug-eruption group) and 14 healthy controls (control group) were recruited from Assiut University Hospitals' Dermatology Department and Outpatient Clinic. Data were collected in the period from October 2017 to December 2018. Patients were assessed clinically by percentage of surface area of the body involvement (body surface area %) and score of toxic epidermal necrolysis. At presentation and after 1 month of treatment, blood samples were taken to evaluate serum IL-21 levels using an enzyme-linked immunosorbent assay.ResultsInside the study, the cruel serum IL-21 level was considerably greater than in the control group, in drug-eruption group was 575.58 ± 94.67 ng/dl, and in the control group was 128.00 ± 73.94 ng/dl with P value of 0.000. The drug-eruption group had a significantly higher serum level of IL-21 before treatment than after treatment with P value of 0.000. Additionally, there was a critical relationship between IL-21 levels in the blood and the severity of the condition. Before and after therapy, there was a significant positive association between blood IL-21 levels and the proportion of body surface area involvement.ConclusionIL-21 levels in the blood were significantly higher in EM and SJS/TEN patients, suggesting that it may have a role in the etiology of EM and SJS/TEN and it could be employed as a marker for the severity of SJS/TEN and patient prognosis in the future.

Clinico-epidemiological profile of genital dermatoses in people living with HIV: A shifting paradigm from venereal to nonvenereal dermatoses.

The protean mucocutaneous manifestations of HIV and the resultant opportunistic infections are well documented. Genital dermatoses can be either venereal or nonvenereal in origin. As the presence of HIV infection greatly increases the chances of acquiring another sexually transmitted pathogen, these are often presumed to be venereal in origin. The aims of the study were to record the different morphologies of genital skin lesions in seropositive patients and to classify them as venereal or nonvenereal in origin. This was an observational study undertaken in seropositive patients with genital skin lesions attending the outpatient department of dermatology at a tertiary health-care center. One hundred and seventy-seven seropositive patients with genital lesions were enrolled. A detailed history was taken; the genital and dermatological examination was performed. None. Males predominated the study population with the majority (79.1%) falling into the reproductive age group of 15-49 years. Nonvenereal genital dermatoses (59%) outnumbered sexually transmitted infections (STIs) (41%) out of which the most frequently encountered were dermatophytosis, scabies, and intertrigo. Other entities recorded were inflammatory dermatoses, cutaneous adverse drug reactions, and tumors. The most common STIs were herpes genitalis (55.4%) and anogenital warts (32.5%). This study showed that nonvenereal genital dermatoses are more common than STIs in people living with HIV. Our findings reiterate the fact that genital lesions should be approached with caution as a presumptive and hasty diagnosis of STI adds greatly to the morbidity of the patient in terms of guilt and shame, and adversely affects the quality of life.

Clinical Profile of Cutaneous Adverse Drug Reactions in HIV Patients: A Cross-sectional Study

Introduction: Cutaneous Adverse Drug Reaction (cADR) is one of the most common clinical presentation in patients with Acquired Immunodeficiency Syndrome (AIDS). These patients are more prone to get cADR because of various factors like altered drug metabolism, immune dysregulation, genetic predisposition, polypharmacy and oxidative stress. So, a methodical study of cADR, including the risk factors, patterns of drug eruption and prognostic factors is of crucial clinical significance. Aim: To determine the prevalence of cutaneous drug reactions in Human Immunodeficiency Virus (HIV) patients and also study the various patterns of cADRs. Materials and Methods: This cross-sectional study was conducted at the outpatient department of Infectious diseases and Medical Centre, Voluntary health services, Chennai, Tamil Nadu, India, from April 2020 to December 2020. A total of 150 HIV patients above 18 years who were taking Anti-retroviral Therapy (ART) were included in this study. After screening for cADR, it was classified as Morbilliform eruption, Erythema multiforme, Stevens Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Fixed Drug Eruption (FDE) etc., The severity of the reaction was graded based on Modified Hartwig and Siegel severity assessment scale. Pearson Chi-square test and Bivariate Pearson Correlation was performed to statistically analyse the data. Results: Amongst total of 150 HIV patients (87 males and 63 females), mean age of the study population was 41.07 years. There was a male predominance with male:female ratio of 1.3:1. About 44% (n=6) of the study population had opportunistic infection. The prevalence of drug eruption in this study was found to be 6% (n=9). Out of which, 55.6% (n=5) of the population had morbilliform eruption and 22.7% had urticarial (n=2) and pruritus (n=2) respectively. About 56% (n=5) of the drug reaction was caused by Tenofovir/Lamivudine/Efavirenz regimen and the remaining 44% (n=4) of the drug eruption was caused by Abacavir/Lamivudine/Dolutegravir regimen. Conclusion: In this study, the prevalence of drug eruption was 6% and majority of the population had morbilliform eruption.

Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A Fresh Look at an Old Foe.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are some of the less common cutaneous adverse drug reactions with significant mortality. This study was undertaken with the objective of studying the demographics and clinical profile of SJS/TEN and identifying parameters associated with mortality. All patients with SJS/TEN over 10 years (2010-2020) were included in the study. Data obtained from in-patient and out-patient records were analysed. A total of 82 patients with SJS/TEN were admitted to our centre over a period of 10 years. Patients with SJS were significantly younger than those with TEN, with a male: female ratio >1 in SJS and <1 in TEN. The most commonly implicated drugs were antiepileptics (n = 29, 35.4%), antibiotics (n = 20, 24.4%). and Non-steroidal antiinflammatory drugs (NSAIDs) (n = 7, 8.5%). The mortality rate in the TEN group was 16% (n = 8). Certain factors such as cutaneous lesions preceding mucosal lesions at onset, high mean Body surface area (BSA) of denudation and a transfer to intensive care unit (ICU) more than 7 days after admission were significantly associated with higher mortality. There was no difference between survivors and deaths in terms of delay in hospitalisation, total disease duration, implicated drug, delay in initiation of therapy, the onset of re-epithelialisation, Severity-of-illness score for TEN (SCORTEN) and total duration of hospital stay. Factors significantly associated with increased mortality in TEN were cutaneous onset of lesions, mean BSA of involvement and transfer to the intensive care unit (ICU) beyond day 7 of admission.

Serum Level of Granulocyte-macrophage Colony-stimulating Factor in Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis

BACKGROUND: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are severe cutaneous adverse drug reactions. Activated T-cells secrete high amounts of cytokines that increase the expression and activity of keratinocytes, including granulocyte-macrophage colony-stimulating factor (GM-CSF). AIMS: The aims of this study were to evaluate the serum level of GM-CSF in SJS and TEN as well as the relationship between it and the progress of SJS and TEN. METHODS: This was a sectional descriptive study conducted at the National Hospital of Dermatology and Venereology, in Hanoi, Vietnam, from October 2017 to September 2019. Forty-eight SJS/TEN patients, 43 erythema multiforme (EM) patients, and 20 healthy controls (HCs) participated. GM-CSF levels were measured using the fluorescence covalent microbead immunosorbent assay (ProcartaPlex Immunoassay Panels kit, Thermo Fisher Scientific, USA). The Mann–Whitney U-test was used to compare serum SJS/TEN levels of the two groups. The Wilcoxon tests were used to compare quantitative variables before and after the treatment. Differences were considered to be statistically significant at p &lt; 0.05. RESULTS: There were 19 SJS patients (39.5%) and 29 TEN patients (60.5%). The mean age was 49.3 years, range of 19–77 years. The male patients were 47.9%. The most common causative drugs were traditional medicine (29.1%), followed by carbamazepine (12.5%), and allopurinol (12.5%). On the day of hospitalization, the mean serum level of GM-CSF in the SJS/TEN group was 10.6 pg/mL, which was significantly higher than that of the EM group (p &lt; 0.05) but not higher than that of the HCs group and was higher than that on the day of re-epithelialization (3.6 pg/mL) and the difference was statistically significant with p &lt; 0.05. CONCLUSION: Serum GM-CSF level can be a good biomarker to evaluate the progress of SJS/TEN.

Clinical patterns of cutaneous adverse drug reactions in tertiary care centre of central India: A cross-sectional study

Clinical patterns of cutaneous adverse drug reactions in tertiary care centre of central India: A cross-sectional study

Clinical features and prognostic factors of severe cutaneous adverse drug reactions: A single-center retrospective study of 209 cases in China.

Severe cutaneous adverse drug reactions (SCAR) are life-threatening and contain drug reactions with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP). We aimed to evaluate clinical features and prognostic factors for SCAR patients. From January 2010 to April 2022, 209 patients with SCAR (DRESS, n=46, SJS/TEN, n=128, AGEP, n=35) were included in this study. Clinical symptoms, laboratory tests, causative drugs, disease courses, treatments, and outcomes were investigated. Antibiotics ranked first (35.9%) followed by traditional Chinese medicine (15.8%) and antiepileptic drugs (14.8%) among causative drugs of SCAR. One patient (2.2%) with DRESS and seven patients (5.5%) with SJS/TEN died in the hospital, while there was no AGEP-related mortality. The multivariate logistic regression analysis showed that high Registry of Severe Cutaneous Adverse Reactions score (OR=2.340, 95% CI=1.192-4.591) and hemoglobin<100g/L (OR=0.126, 95% CI=0.016-0.983) were independent risk factors of DRESS. Anemia (OR=0.191, 95% CI=0.037-0.984) and body surface area detached involved at day 1 (OR=2.749, 95% CI=1.115-6.778) were independent risk factors of SJS/TEN for severe acute complications and hospital death (P<0.05). Lymphocytopenia (OR=0.004, 95% CI=0.000-0.553) was a risk factor of AGEP for acute complications (P=0.028). This study reveals the clinical features and independent prognostic factors for SCAR, which may be helpful in the clinical management for SCAR patients.

Cutaneous Adverse Drug Reaction Among HIV-Infected Patients Starting Antituberculosis Treatment

Introduction. Treatment of tuberculosis (TB) in HIV patients is complicated due to numerous comorbidities and possible adverse effects. One of which is cutaneous adverse drug reaction (CADR). This adverse event is often difficult to manage because of multiple medications the patients get. The objective of this study was to know the prevalence and risk factors of CADR among HIV-infected patients starting anti-TB treatment. Methods. This retrospective study reviewed data from medical records of new patients at Working Group on AIDS outpatient clinic at Cipto Mangunkusumo Hospital, Indonesia in January 2008-December 2010 that had started anti-TB treatment. Risk factors of CADR among HIV patients treated with antituberculosis drugs evaluated were sex, age, route of HIV transmission, TB manifestation, and baseline CD4+ cell count. Numeric data were analyzed using independent T-test if normally distributed, otherwise Mann Whitney U test were used. Chi-square or Fisher’s exact test were used for categorical data. p-value was considered significant if below 0.05. Results. Of 454 HIV-infected patients that started anti-TB treatment, median age was 30 years. Most patients were male and intravenous drug users/IDU. Median baseline CD4+ cell count was 61 cells/ μL. There were 10.6% subjects that developed CADR. Most common manifestations were maculopapular rashes (66.7%), followed by erythema multiforme (14.6%), and Stevens Johnson Syndrome (8.3%). Anti-TB drugs were stopped and then re-challenge was conducted in 54.2% patients. Anti-TB drugs were continued and only the suspected drug was stopped in 29.2% patients. The offending drugs were cotrimoxazole (41.7%), rifampicine (41.7%), ethambutol (16.7%), pyrazinamide (14.6%), pyrimethamine (12.5%), isoniazide (10.4%), streptomycin (8.3%), efavirenz (8.3%), fixed dose combination of antituberculosis drugs (8.3%), and nevirapine (4.2%). The proportion of CADR was higher in woman than man (12% vs. 10.3%, p=0.66), non-IDU than IDU (13% vs. 9.2%, p=0.20), without extrapulmonary TB than extrapulmonary TB (11.1% vs. 9.4%, p=0.29), but the associations weren’t statistically significant. Median age was higher (31 vs. 30 years, p=0.32) and CD4 cell count (59.5 vs. 62 sel/μL, p=0.96) was lower in CADR group than non CADR group. Conclusion. The prevalence of CADR among HIV-infected patients starting anti-TB treatment was 10.6%. Sex, age, route of HIV transmission, TB manifestation, and baseline CD4+ did not have statistically significant association with CADR.

Clinico-epidemiological study of cutaneous adverse drug reactions among the in-patients of dermatology department, Goa Medical College, Goa

&lt;p class="abstract"&gt;&lt;strong&gt;Background:&lt;/strong&gt; An adverse drug reaction (ADR) remains often remains underreported and leads to underestimated cause of morbidity and mortality. ADR frequently manifests as adverse cutaneous drug reactions (ACDRs) and manifestations varies from mild acneiform eruption to life threatening events like toxic epidermal necrolysis. Aim was to study clinic-epidemiological pattern of various ACDRs among inpatients in department of dermatology and study common drugs causing ACDRs and assess causality and severity.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Methods:&lt;/strong&gt; This retrospective observational study was conducted for a period of one year in department of dermatology in Goa Medical College. All patients fulfilling criteria of study were included.&lt;strong&gt;&lt;/strong&gt;&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Results:&lt;/strong&gt; A total of 24 patients were studied. Most common ACDR was observed in age group of 21-40 years. Stevens Johnson syndrome (SJS) (25%) was most common ACDR followed by morbilliform drug rash (20.8%). Other manifestation was DRESS (12.5%), fixed drug eruption (FDE) (12.5%) and angioedema (12.5%), acute generalized exanthematous pustulosis (AGEP) (8.33%); erythroderma (4.16%) and urticaria (4.16%). Antibiotics were commonly implicated drug category in causation of ACDRs accounting for 37.5% followed by NSAIDS (25%). Based on causality assessment, probable cases had higher incidence - 54.2% followed by possible 37.5%. All patients were considered to have severe reaction as patients required hospitalization for management of adverse reactions.&lt;/p&gt;&lt;p class="abstract"&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; ADRs are under-reported due to various factors and practicing doctors should be encouraged to report ACDRs in order to improve medical therapy for the benefit of healthcare workers and patients worldwide.&lt;/p&gt;

Pharmacovigilance of cutaneous adverse drug reactions-a focused research in times of COVID pandemic

Severe cutaneous adverse drug reactions are limiting, ranging from 5 cases per million including acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia systemic symptoms (DRESS) to 1 case per million of toxic epidermal necrolysis. Cutaneous adverse drug reactions following drug therapy of COVID-19 are not uncommon. Viral infection and drug interactions predisposes to the development of cutaneous adverse drug reactions, as already documented with Epstein-Barr virus, cytomegalovirus, human herpesvirus 6, and HIV. The Adverse drug reaction monitoring center of CNMCH has actively participated in pharmacovigilance programme of India by reporting few adverse drug reactions including the following cases. It is iterated that pharmacovigilance programme extends beyond just mere detection and reporting of adverse drug reactions and also should involve in assessment and understanding the cases, thus facilitating control and prevention of these cases. Particularly in times of COVID pandemic there has been continuous amendment in the treatment guidelines both at the central and state level. Incorporation of various antibiotics, antiparasites and antiviral drugs for the treatment of COVID, has potentiated the risk of development of drug allergies. Admittedly, the detailed understanding of drug allergy cases has been in general constrained with a relative lack of access to standardized laboratory diagnostic tests. Focused research is the need of the hour in order to understand the drug allergies better. In this study we have included those cases reported by department of medicine and dermatology of Calcutta national medical college and hospital in the past six months. All the cases were COVID positive and were treated conservatively by de-challenging the culprit drug and administration of antihistamines, topical steroids, while a few was put on systemic steroid therapy. There were six such reported cases of cutaneous adverse drug reaction following COVID treatment. There were four cases of maculopapular drug eruptions, while the other cases were diagnosed with fixed drug eruptions and acute generalized exanthematous pustulosis respectively. All the cases were reported under pharmacovigilance programme of India.