Predictors of the Common Adverse Drug Reactions of Statins

Background: The main objective of study is to monitor and analyze the adverse drug reactions (ADRs) of ART and to assess causality and severity of the ADRs detected.Methods: It is a prospective observational study conducted in the ART centre of a tertiary care teaching hospital in central India. The data collected were recorded on standard ADR reporting forms. Causality was assessed by Naranjo’s algorithm. Severity of ADR’s was assessed by modified Hartwig and Seigel scale. Modified Shumock and Thorton criteria used for preventability assessment.Results: In twelve months duration 351 patients on ART were observed for ADRs. Total 166 ADRs detected in 96 patients. Incidence of ADRs was slightly more in female. The common systems involved were gastrointestinal 42.77% followed by nervous system 18.07%, musculoskeletal 15.06% skin/mucous membrane 07.83%, metabolic and nutritional 04.82%, red blood cell disorders 01.20 %, endocrinal 00.60 % and others 09.64%. The causality assessment as per Naranjo’s scale showed that out of 166 ADRs, 28.92% were probable and 71.08% were possible. Severity assessment by modified Hartwig and Siegel scale showed that 83.34% ADRs were mild and 15.66% were moderate. 46.39 % ADRs were probably preventable.Conclusions: Considering the magnitude of ADR related problems, there is a need for greater awareness among health care professionals, to detect and report them. These ADRs if recognized in time and managed properly can prevent treatment interruption.

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Assessment of Patient’s Response about Adverse Drug Reactions Receiving AC (Adriamycin, Cyclophosphamide) Therapy: A Survey Research

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2021/v33i26a31467 ◽

2021 ◽

pp. 8-13

Author(s):

Jameela Jamali ◽

Abdullah Dayo ◽

Naheed Memon ◽

Ubed-ur-Rehman Mughal ◽

Muhammad Akram Khatri ◽

...

Keyword(s):

Breast Cancer ◽

Adverse Drug Reactions ◽

Sampling Method ◽

Medical Intervention ◽

National Formulary ◽

Drug Reactions ◽

Severity Scale ◽

High Severity ◽

Cancer Hospital ◽

The Common

Background: Adverse drug reactions (ADRs) are most common among cancer patients receiving treatment. AC therapy which is a combination protocol of Adriamycin (doxorubicin) and Cyclophosphamide are the common therapies used for breast cancer treatment due to their effectiveness and cost of therapy breast cancer. AC combination is administered every 3 weeks, and 4 cycles are given. Objectives: To assess various ADRs reported by patients on AC combination therapy and their severity to ensure safe and effective treatment. Design: Prospective observational. Setting: Cancer hospital Jamshoro Pakistan. Patients and Methods: A hospital based observational study included 160 female patients suffering from breast cancer and receiving AC combination for treatment by purposive sampling method from June 2015- January 2018 at cancer hospital Jamshoro Pakistan. ADRs reported were compared against international standard references of drug literature such as British National Formulary (BNF) 2017 and ADR severity assessment scale (Modified Hartwig and Siegel scale). Main Outcome Measures: Frequency and severity of ADRs. Results: The common ADRs reported were, nausea and vomiting, acidity, fatigue, hair fall as common non-hematologic and leukopenia among hematologic ADRs. Those patients reported high severity ADRs according to severity scale persist for longer duration and required antidote for management with medical intervention. Conclusion: The present study shows that a patient’s response towards AC therapy is critical and therefore each patient must be monitored and those at high risk of developing ADRs from this therapy must be provided additional care.

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Adverse drug reactions or events in children with assessment of causality and severity: a retrospective analysis from Bhavnagar

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20205127 ◽

2020 ◽

Vol 9 (12) ◽

pp. 1883

Author(s):

Jayendra R. Gohil ◽

Aniket B. Sarwade ◽

Hardik R. Chauhan ◽

Jay R. Jasani ◽

Hinal R. Gujrati

Keyword(s):

Adverse Drug Reactions ◽

Adverse Drug Events ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Care Hospital ◽

Drug Reactions ◽

Pediatric Age Group ◽

Skin Redness ◽

The Common ◽

Probable Category

Background: Objective was to study the occurrence of adverse drug reactions in pediatric age group in a tertiary care hospital setting.Methods: A retrospective study was undertaken to analyze adverse drug events in pediatrics wards of a tertiary care hospital. Any event marked as ‘suspected adverse drug reaction’ was included in the study and ADR forms were analyzed for causality and severity. Other parameters like age and sex, class of drug, types of ADR, commonly involved systems and polypharmacy were studied.Results: Total 74 cases of admitted patients (13 deaths: 11 infants, 6 neonates) with severe ADR were studied of whom 39% were females. Antimicrobials were the commonest drug class (54%) with Skin most commonly involved. 77% cases were of probable category according to Naranjo’s scale of causality assessment. 11% cases were prescribed polypharmacy.Conclusions: Antibiotics were the class of drug causing maximum ADRs. The commonest system involved was skin. Redness, itching & rashes were the common symptoms. Antimicrobials should be used judiciously. Polypharmacy should be avoided. ADR reporting should be strengthened. Extra vigilance is required for infants and neonate’s prescriptions.

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Pharmacovigilance in oncology: pattern of spontaneous notifications, incidence of adverse drug reactions and under-reporting

Brazilian Journal of Pharmaceutical Sciences ◽

10.1590/s1984-82502014000200021 ◽

2014 ◽

Vol 50 (2) ◽

pp. 411-422 ◽

Cited By ~ 1

Author(s):

Marília Berlofa Visacri ◽

Cinthia Madeira de Souza ◽

Rafaela Pimentel ◽

Cristina Rosa Barbosa ◽

Catarina Miyako Shibata Sato ◽

...

Keyword(s):

Adverse Drug Reactions ◽

Tertiary Care ◽

Therapeutic Window ◽

Type B ◽

Drug Reactions ◽

Oncology Patients ◽

Taste Disturbance ◽

Antineoplastic Treatment ◽

The Common ◽

Grade 3

The high toxicity and narrow therapeutic window of antineoplastic agents makes pharmacovigilance studies essential in oncology. The objectives of the current study were to analyze the pattern of spontaneous notifications of adverse drug reactions (ADRs) in oncology patients and to analyze the incidence of ADRs reported by outpatients on antineoplastic treatment in a tertiary care teaching hospital. To compose the pattern of ADR, the notification forms of reactions in oncology patients in 2010 were reviewed, and the reactions were classified based on the drug involved, mechanism, causality, and severity. To evaluate the incidence of reactions, a questionnaire at the time of chemotherapy was included, and the severity was classified based on the Common Terminology Criteria. The profiles of the 10 responses reported to the Pharmacovigilance Sector were type B, severe, possible, and they were primarily related to platinum compounds and taxanes. When the incidence of reactions was analyzed, it was observed that nausea, alopecia, fatigue, diarrhea, and taste disturbance were the most frequently reported reactions by oncology patients, and the grade 3 and 4 reactions were not reported. Based on this analysis, it is proposed that health professionals should be trained regarding notifications and clinical pharmacists should increasingly be brought on board to reduce under-reporting of ADRs.

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Analysis of spontaneously reported cutaneous adverse drug reactions in a tertiary care teaching hospital in South India

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20185085 ◽

2018 ◽

Vol 8 (1) ◽

pp. 27

Author(s):

Vijaya Chandra Reddy Konda ◽

Sree Surya Durga Devi Pilla ◽

A. Surekha ◽

K. R. Subash ◽

K. Umamaheswara Rao

Keyword(s):

Adverse Drug Reactions ◽

Continuous Monitoring ◽

Antimicrobial Agents ◽

Tertiary Care ◽

Maculopapular Rash ◽

Drug Reactions ◽

Drug Eruptions ◽

Fixed Drug ◽

The Common ◽

Clinical Patterns

Background: Skin is the most common organ involved in adverse reactions due to drugs. With newer drugs released into market every year, there is changing pattern of the reported cutaneous adverse drug reactions (ADRs). In order to ensure safer use of medicines in patients, there is need for continuous monitoring of ADRs. This is a retrospective study to analyse spontaneously reported cutaneous ADRs.Methods: All the cutaneous ADRs reported between January 2017 and September 2018 were analysed for clinical patterns, suspected medications, causality, severity and preventability.Results: Of the 1035 reports received during the study period, 232 (22.41%) included cutaneous reactions. 113 (48.7%) were male and 119 (51.29%) were female. Maculopapular rash 70 (30.17%), pruritus 31 (13.36%), palmar plantar erythrodysesthesia 30 (12.93%), acne 19 (8.19%), urticaria 16 (6.89%) and fixed drug eruptions (FDE) 13 (5.6%) were the common clinical patterns. Antimicrobial agents followed by anticancer drugs, nonsteroidal anti-inflammatory drugs (NSAIDs), hormones and related drugs, and antiepileptic drugs were the common suspected group of drugs. Causality assessment as done by WHO-UMC scale showed that 3 (1.29%) were certainly related, 174 (75%) were probably related and 55 (23.7%) were possibly related to the suspected medication.Conclusions: Cutaneous ADRs are most frequently reported ADRs in the present study. With newer drugs released into market, there is a need for continuous monitoring of use of drugs to promote safer use of medicines in patients.

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Adverse drug reactions triggered by the common HLA-B*57:01 variant: virtual screening of DrugBank using 3D molecular docking

Journal of Cheminformatics ◽

10.1186/s13321-018-0257-z ◽

2018 ◽

Vol 10 (1) ◽

Cited By ~ 1

Author(s):

George Van Den Driessche ◽

Denis Fourches

Keyword(s):

Molecular Docking ◽

Virtual Screening ◽

Adverse Drug Reactions ◽

Drug Reactions ◽

The Common

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CUTANEOUS ADVERSE DRUG REACTIONS IN GENERAL PRACTICE - AN ANALYSIS

International Journal of Ayurveda and Pharma Research ◽

10.47070/ijapr.v4i1.73 ◽

2016 ◽

Author(s):

*G. Rajaram ◽

P. Sugirda ◽

R. Lenin

Keyword(s):

Urban Area ◽

General Practitioners ◽

Adverse Drug Reactions ◽

Maculopapular Rash ◽

New Drugs ◽

Drug Reactions ◽

Fixed Drug Eruption ◽

Fixed Drug ◽

The Common ◽

Reported Data

Aim: To study the pattern of cutaneous adverse drug reactions presenting to general practitioners in a semi urban area. Â Methodology and Results: This study was conducted among general practitioners of Villupuram, a semi urban area in Tamilnadu State. During the study, a total of 60 CADRs were reported. Data were collected using standard CDSCO ADR form. The majority of CADRs were observed in the age group of 20-40 years. According to WHO causality assessment, 48 were probable and 12 were possible. The severity assessment using modified hartwig and seigel revealed 18 mild, 41 moderate and one severe CADRs. The common drug groups implicated are antibiotics followed by NSAIDS and anticonvulsants. Maculopapular rash was the most common presentation of CADRs.Conclusion: Among the various types of CADRs seen in this study, Maculopapular rash was the most common followed by fixed drug eruption. studies antimicrobials were the most common causative agent followed by NSAIDs and anti- convulsants. This study on CADRs gains importance as the pattern of drug use is changing periodically and everyday many new drugs enter the market.

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Clinical Profile of Cutaneous Adverse Drug Reactions in a Tertiary Care Centre

IRA-International Journal of Applied Sciences (ISSN 2455-4499) ◽

10.21013/jas.v3.n3.p12 ◽

2016 ◽

Vol 3 (3) ◽

Cited By ~ 1

Author(s):

Priya Prathap ◽

Elsy M.I ◽

Ajitha K. N ◽

Ajith Kumar ◽

Sandhya George

Keyword(s):

Adverse Drug Reactions ◽

Tertiary Care ◽

Maculopapular Rash ◽

Clinical Profile ◽

Drug Reactions ◽

Fixed Drug Eruption ◽

Tertiary Care Centre ◽

Dermatology Department ◽

Female Ratio ◽

The Common

<div>Context: Cutaneous adverse drug reactions (cADR) constitute 2-3% of all hospitalized patients. However there is paucity of data regarding occurrence of cADR among out patients. Hence we decided to do a study on clinical profile of cADR and to find out the common drugs resulting in cADR . Objective: To observe the clinical spectrum and the causative drugs of cADR among patients attending Dermatology Department in our hospital. Methods: Patients with cADR who attended Dermatology Out Patient Department (OPD) in our institution were studied for a period of one year.Results:71 patients were diagnosed to have cADR. Male to female ratio was 1.15 :1. Maculopapular rash (22/71 ; 31%) was the commonest presentation followed by generalised pruritus (16/71; 22.5%) , fixed drug eruption( FDE) ( 8/71 ;11.3%) and urticaria (5/71 ;7%). Antimicrobials (40.8%), NSAIDS (22.5%) and Antiepileptics (22.5 %) were the common drugs responsible for these eruptions. </div>

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A study on cutaneous adverse drug reactions in a tertiary care center in Rajnandgaon, Chattisgarh

International Journal of Research in Dermatology ◽

10.18203/issn.2455-4529.intjresdermatol20194678 ◽

2019 ◽

Vol 5 (4) ◽

pp. 839

Author(s):

Pooja Pandey ◽

Prabhat Pandey ◽

Sharad Manore ◽

Darshan Sandesara

Keyword(s):

Adverse Drug Reactions ◽

Care Center ◽

Tertiary Care ◽

Age Groups ◽

Drug Reactions ◽

Presenting Symptoms ◽

Causative Agents ◽

Life Threatening ◽

Cutaneous Reactions ◽

The Common

Background: Cutaneous reactions are one of the most common types of adverse drug reactions which may vary from mildly discomforting to those that are life-threatening.Methods: This prospective, observational study was done in the department of dermatology. Patients with suspected drug rash, of either sex or all age groups were included in the study.Results: A total of 114 patients were enrolled in the study. The most common presenting symptoms of cutaneous adverse drug reactions (CADRs) were itching, burning sensation and pigmentation with 61.31%, 13.87% and 10.22% respectively. A total of 21 different CADRs were observed. The common causative agents were of anti-microbial, nervous system and musculoskeletal class in both outdoor and indoor patients with 51 (37.22%), 21 (15.32%) and 25 (18.24%) respectively.Conclusions: The most common CADR observed in the study was antimicrobials and NSAIDs were the most common causative drugs.

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