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 Drugs were withdrawn in 89% of cases and 85% cases recovered.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.

Analysis of cutaneous adverse drug reactions in a tertiary care teaching hospital

Background: Cutaneous Adverse Drug Reaction (CADR) is considered as one of the reasons for discontinuation of drug as well as medication non-adherence. This study analyses the common drugs causing CADR, clinical spectrum of different types of CADR, causality and drugs causing severe CADR.Methods: This was a retrospective cross-sectional observational study conducted by the Department of Pharmacology, Coimbatore Medical College, Coimbatore, Tamil Nadu, India. The study was conducted using data collected in CDSCO’s ADR reporting forms with CADR from June 2015 to July 2017. Patient’s information, details related to adverse drug reaction, suspected medication details, concomitant medication history, causality and seriousness were recorded.Results: A total of 102 CADR were evaluated in this study. The mean age of sample was 37.21±20.33 years. Maximum number of cases was in the age group of 40-49 years. Male to female ratio was 0.96:1. The commonly incriminated drugs causing CADR were antimicrobial agents. Ciprofloxacin (21.57%), phenytoin (9.8%), diclofenac sodium (6.86%), anti-snake venom (6.86%) and vancomycin (3.92%) were the common drugs implicated in CADR. Maculopapular rash and itching were the most common CADR. Anticonvulsants especially phenytoin was commonly associated with severe CADR.Conclusions: The present study has made an impact on all departments of this institution and awareness has been created about spontaneous reporting of all adverse drug reactions in CDSCO ADR reporting forms to the pharmacovigilance centres. Thus, sound knowledge about the adverse drug reactions may decrease the occurrence of drug induced morbidity and mortality.

An observational study to monitor cutaneous adverse drug reaction profile in Dermatology Department of tertiary care teaching hospital

Background: Incidence of cutaneous adverse drug reactions (CADRs) in developed countries is 1 to 3% and in developing countries, it is much higher i.e. 2 to 6%. 1 in 1000 hospitalized patients will develop severe cutaneous adverse reaction. Maculopapular rash represents majority of cutaneous drug reaction followed by urticaria. Most frequently elicited CADRs are associated with antimicrobials and NSAIDs. This study was designed to monitor Cutaneous adverse drug reaction profile of tertiary care teaching hospital.Methods: This is a prospective observational study of 6 months� duration to monitor cutaneous adverse drug reactions in dermatology department of tertiary care teaching hospital. CADRs were analysed with respect to demographic details, suspected drugs and type of reaction. Causality assessment is by Naranjo algorithm. Data is represented in tables and graphs. Data is analyzed in Microsoft excel 2007.Results: Total 57 cases of cutaneous adverse drug reactions were reported. Among them, 57.9% were in males and 42.1% were in females. Majority of CADRs were due to antiretroviral drugs (38.5%) followed by antibacterial (28%) and antiepileptics (14%). Maculopapular rash is most common CADR (35%). Causality of 74% CADRs were probable according to Naranjo algorithm.Conclusions: CADRs are more commonly associated with antiretroviral therapy (ART), antibacterial drugs and antiepileptic drugs. In case of ART, antiepileptic drug and drugs used in chronic illness compliance plays a major role in the success of therapy. Adverse drug reactions lead to problem of non compliance and failure of therapy. Cutaneous adverse reactions like FDE heal with hyper pigmentation leads to cosmetic problem. Stevens Johnson syndrome (SJS) is life threatening that requires prompt withdrawal of drug and intensive medical management. Many drugs are available without prescription in India leading to problem of misdiagnosis of CADRs. So, data obtained from this study helps in proper diagnosis and treatment of CADRs.

Clinical Analysis of Drug Eruptions among Inpatients Seeking a Consultation with the Department of Dermatology / 대한피부과학회지

BACKGROUND: Drug eruptions are common in hospitalized patients. Rapid and accurate diagnosis is essential but often difficult. OBJECTIVE: This study defined the clinical features and causative drugs among inpatients presenting with drug eruptions. METHODS: We retrospectively analyzed the clinical and laboratory data of inpatients who sought consultations with the Dermatology Department for a diagnosis of drug eruptions. RESULTS: A total of 228 patients were diagnosed with drug eruptions, and this study included 139 patients. The highest incidence of drug eruptions was observed in patients in their 50s (22.3%). The most common latent period was up to 1 week (57.6%). The most common drug eruptions were exanthematous eruptions (59.7%), acneiform eruptions (10.8%), and urticaria (9.3%). The most common causative drugs were antibiotics (53.2%), followed by anticancer drugs (19.4%), and contrast media (6.5%). Laboratory abnormalities included eosinophilia (15.8%), abnormal liver function tests (7.9%), leukopenia (4.3%), an elevated serum creatinine level (2.2%), and leukocytosis (0.7%). CONCLUSION: In descending order, the most frequent drug eruptions were exanthematous eruptions, acneiform eruptions, and urticaria, and the most common causative drugs were antibiotics, anticancer agents, and contrast media. Prompt diagnosis and discontinuation of the causative drug are important in this context. Clinicians should be aware of cutaneous adverse drug reactions.

Drug-induced panniculitis due to deworming in a dog ­ case report / Paniculite farmacodérmica decorrente de vermifugação em um cão - relato de caso

Outpatient clinics, clinics, and veterinary hospitals in the state of São Paulo and other Brazilian states commonly prescribe broad-spectrum vermicidal agents. The prescriptions are not based on coproparasitological examination results and drugs, including those used for the elimination of enteric parasites, are not innocuous and can potentially cause health hazards. Therefore, we report a clinical case of drug-induced panniculitis caused by deworming and show the actual occurrence of endoparasites in canine and feline outpatients at HOVET-USP.(AU)

É prática corrente em ambulatórios, consultórios, clínicas e hospitais veterinários paulistas, por não dizer brasileiros, a prescrição de ativos com ação vermicida, no senso lato, sem o embasamento do, hoje até prosaico, exame coproparasitológico. É sabido há muito que todo e qualquer fármaco não é inócuo e pode potencialmente acarretar agravos à saúde, e dentre estes incluem-se os ativos destinados à erradicação de parasitos entéricos. Decidiu-se assim por se relatar um caso clínico de paniculite farmacodérmica decorrente de vermifugação, bem como situar a real ocorrência de endoparasitas em pacientes, caninos e felinos, trazidos para atendimento ambulatorial no HOVET-USP.(AU)

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS):A Review of 21 Cases over 7 years Period from Selayang Hospital

Introduction: DRESS is an uncommon severe cutaneous adverse drug reaction, which is under recognized. In this review, we aim to study the clinical characteristics of patients with DRESS that presented to our hospital. Methods: We conducted a retrospective analysis on the data of all the patients with DRESS from January 2006 to December 2012 in Selayang Hospital. Results: Twenty-one patients were included with median age of 33 and male to female ratio of 1:1. Allopurinol was the most frequent causative drug followed by anti-tuberculous drugs. The mean latency period was 28.6 days. All patients had macula-papular rash of which 6 progressed to erythroderma. Liver was the most frequent extra cutaneous organ involvement with median peak alanine transaminase of 746 iu/l, (range 45-3677) and median peak aspartate transaminase of 632 iu/l (range 30-3136). Six patients (28.5%) had acute liver failure. The mainstay of treatment was systemic corticosteroid. Mortality rate was 23.8%. Conclusion: DRESS is a severe cutaneous adverse drug reaction with a myriad of clinical presentation and is associated with mortality. Our series has higher mortality compared to most other reported studies, most probably due to referral bias. Early recognition is crucial.

Incidence of cutaneous adverse drug reactions among medical inpatients of Sultanah Aminah Hospital Johor Bahru

Introduction: Cutaneous adverse drug reactions (cADRs) are common. There are only few studies on the incidence of cADRs in Malaysia. Objective: To determine the incidence, clinical features and risk factors of cADRs among hospitalized patients. Methods:A prospective study was conducted among medical inpatients from July to December 2014. Results: A total of 43 cADRs were seen among 11 017 inpatients, yielding an incidence rate of 0.4%. cADR accounted for hospitalization in 26 patients. Previous history of cADR was present in 14 patients, with 50% exposed to the same drug taken previously. Potentially lifethreatening severe cutaneous adverse reactions (SCAR), namely drug reaction with eosinophilia and systemic symptoms (DRESS: 14 cases) and Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN: 6 cases) comprise almost 50% of cADRs. The commonest culprit drug group was antibiotics (37.2%), followed by anticonvulsants (18.6%). Cotrimoxazole, phenytoin and rifampicin were the main causative drugs for DRESS. Anticonvulsants were most frequently implicated in SJS/TEN (66.7%). Most cases had “probable” causality relationship with suspected drug (69.8%). The majority of cases were of moderate severity (65.1%), while 18.6% had severe reaction with 1 death recorded. Most cases were not preventable (76.7%). Older age (> 60 years) and mucosal involvement were significantly associated with a more severe reaction. Conclusion: The incidence of cADRs was 0.4%, with most cases classified as moderate severity and not preventable. The commonest reaction pattern was DRESS, while the main culprit drug group was antibiotics. Older age and mucosal membrane involvement predicts a severe drug reaction.

Toxic epidermal necrolysis: a severe cutaneous adverse drug reaction.

Toxic epidermal necrolysis (TEN) is a rare but serious is a rare but potentially lifethreatening condition. It is primarily a cutaneous reaction to various precipitating agents, characterized by wide spread erythema and detachment of the epidermis from the dermis. Among the various cutaneous adverse drug reactions, TEN occupy a primary place in terms of mortality. In TEN large sheets of skin are lost from the body surface, thereby decreasing the protecting function of the skin, which results in complications. Usually, TEN is self-limited in absence of complications. If complicated by sepsis, there will be increased chances of mortality. The main treatment would be cessation of the causative drug and early admission of the patient for supportive care and minimizing the occurrence of complications. The present articles reviews the etiology, pathophysiology, differential diagnosis and treatment protocol, with a case of TEN occurrence in a child of 4 years age after consuming phenytoin syrup for febrile convulsions.

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 butterfl y 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 confi rmed as ATT induced hypopigmented rash. WHO-UMC causality assessment showed a probable association.

Eritema pigmentar fixo simulando herpes labial relacionado ao uso de fluconazol / Fixed drug eruption simulating herpes labialis related to fluconazole

O eritema pigmentar fixo geralmente representa uma reação cutânea adversa a medicamentos caracterizada pelo surgimento de lesões eritematosas arredondadas ou ovais que recorrem no mesmo sítio em minutos a horas após uma nova exposição ao medicamento previamente utilizado. As lesões podem ser únicas ou múltiplas e esmaecem em poucos dias deixando pigmentação hipercrômica residual, sendo os anti-inflamatórios e antibióticos, frequentes causadores. Já o herpes labial é causado principalmente pelo HSV1 e se manifesta com vesículas agrupadas sobre base eritematosa com posterior evolução para crostas e pode ser desencadeado por estresse, trauma etc. O objetivo do presente trabalho é demonstrar um caso de eritema pigmentar fixo simulando herpes labial, relacionado ao uso de fluconazol, visto que existem relativamente poucos relatos desta associação na literatura médica...

Cutaneous Adverse Drug Reactions observed in a Dermatology Clinic, Penang General Hospital

Background Cutaneous Adverse Drug Reaction (CADR) is commonly encountered in our daily clinical practice1. Knowledge of the various patterns of CADR and the common offending agents will certainly help the physician in assessing the likelihood of the drug induced eruption as opposed to another dermatological diagnosis. Objectives To improve the understanding of CADRs in Penang General Hospital,To evaluate the incidence of CADR in Dermatology clinic Penang Hospital, to identify the common offending drugs and to describe the characteristics of CADR and to identify the associated risk factors of developing CADR. Materials and Methods This prospective study covers a 12-month period from April 2005 to March 2006. Demographic characteristics, causative drugs, management and treatment outcome were analysed. Results A total of 174 cases were referred to the Dermatology Clinic over 1-year period (Incidence of 4.9% of Dermatology Clinic new case attendees). Chinese comprises of 51.4%, followed by Malay 32.4%, Indian 10.8% and others 5.4%. Male to female ratio was 1.2:1. 74.1 % of CADR occurred between 13 - 59 year age group. The offending drugs included antimicrobials 28.6%, antituberculous 19.7%, analgesics 17.7%, allopurinol 8.4%, anticonvulsants 5.4%, HAART 1.0%, traditional medicines 2.0% and others 17.2%. High proportion of erythema multiforme syndrome cases was observed (23.5%). Toxic epidermal necrolysis has a high mortality rate. It was caused by amoxycillin, sulphonamide and phenytoin. 80.5% of CADR occurred within 2 weeks of drug introduction. Overall mortality rate secondary to CADR was 2.3%. Risk factors identified included poly-pharmacy (37.9%), renal insufficiency (31.0%), personal history of previous drug allergy (19.0%), liver disorder (18.4%), tuberculosis (16.7%), HIV infection (10.3%), autoimmune disorders (6.3%) and hematological malignancy (4.0%). Conclusions Diagnosis of CADR requires a high index of suspicion especially in those having symmetrical eruption within 2 months in relation to initial dose of medication, particularly the high risk groups.

Skin test in drug eruption Five years experience at Dr. Cipto Mangunkusumo General Hospital, Jakarta.

Side effect of a drug should always considered by the physician in prescribing the drug for patients. Drug eruption could be very severe and re-exposure to traces of possible causative drugs may induce the same or even fatal clinical type of skin lesion. The aim of the study was to evaluate the role of skin test, an alternative in-vivo methods, in determining the cause of drug eruption. A retrospective study on results of skin test (patch and prick test) in drug eruption was conducted during 5 years period (1998-2002), with special interest on clinical type of lesion. The most prominent clinical type were fixed drug eruption(FDE), urticaria, eczematous eruption, exanthematous eruption, and erythroderma. Skin test was done on 125 out of 746 patients with drug eruption, and 34.4% gave positive results. In some mild cases of urticaria and FDE oral provocation test was done with special precaution. The results showed that skin test could be considered as an alternative, safe and relatively easy way to the oral challenge test to find the causative drug in drug eruption, especially the severe form.