scholarly journals Paediatric safety signals identified in VigiBase: Methods and results from Uppsala Monitoring Centre

2019 ◽  
Vol 28 (5) ◽  
pp. 680-689 ◽  
Author(s):  
Kristina Star ◽  
Lovisa Sandberg ◽  
Tomas Bergvall ◽  
Imti Choonara ◽  
Pia Caduff‐Janosa ◽  
...  
Keyword(s):  
Uppsala Monitoring Centre ◽  
Monitoring Centre ◽  
Uppsala Monitoring ◽  
Safety Signals

scholarly journals ALLOPURINOL-INDUCED STEVENS–JOHNSON SYNDROME AND TOXIC EPIDERMAL NECROLYSIS: A CASE REPORT

2019 ◽  
pp. 5-7 ◽  
Author(s):  
MANIK CHHABRA ◽  
ANKIT GAUR
Keyword(s):  
Toxic Epidermal Necrolysis ◽  
World Health ◽  
Stevens Johnson Syndrome ◽  
Uppsala Monitoring Centre ◽  
Self Medication ◽  
Monitoring Centre ◽  
Johnson Syndrome ◽  
Chief Complaints ◽  
Health Organization ◽  
Uppsala Monitoring

Allopurinol is used for the treatment of gout and related conditions; it is associated with various adverse drug reactions (ADRs) such as Stevens– Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). A 50-year-old female was presented to the emergency ward with chief complaints of reddish pinpoint lesions over the back, chest, abdomen, and lower limb-upper limb for the past 6 days. She was diagnosed with SJS. On medication interview, it was revealed that she was on allopurinol therapy, which she took 5 days back as a self-medication. The World Health Organization - Uppsala Monitoring Centre (WHO) scale was used to access the causality assessment, ADR was found to be probable. The drug was withdrawn from the therapeutic regimen of the patient. The patient was discharged after 25 days from the hospital. Allopurinol has the strongest association with SJS with TEN. There should be a screening of HLA-B 5801 antigens before commencing the allopurinol therapy to the patients.

Induziert Methylphenidat Leberschäden? – Analyse von Spontanmeldungen an das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

2018 ◽  
Vol 46 (4) ◽  
pp. 342-348 ◽  
Author(s):  
Stefanie Fekete ◽  
Marcel Romanos ◽  
Manfred Gerlach
Keyword(s):  
Uppsala Monitoring Centre ◽  
Hepatic Disorder ◽  
Fand Sich ◽  
Monitoring Centre ◽  
Uppsala Monitoring

Zusammenfassung. Spontanmeldungen an das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) wurden bezüglich Leberschädigungen unter einer Therapie mit Methylphenidat (MPH) gesichtet. Unter Anwendung der Bewertungskriterien des Uppsala Monitoring Centre (UMC) der Weltgesundheitsorganisation (WHO) erfolgte eine Einschätzung der Verdachtsfälle hinsichtlich eines möglichen kausalen Zusammenhangs. Ermittelt wurden in der Nebenwirkungsdatenbank des BfArM Verdachtsfälle aus Deutschland über den Zeitraum vom 01.01.2006 bis einschließlich 23.05.2016. Mithilfe der Suchstrategie „Standardized MedDRA Queries“ (SMQ) wurde in der Datenbank nach dem Wirkstoff MPH und der potenziellen unerwünschten Arzneimittelwirkung (UAW) „Hepatic Disorder“ gesucht. Die Spontanmeldungen wurden auf Vollständigkeit geprüft und klinisch beurteilt. Insgesamt handelte es sich um 60 Verdachtsfälle von Leberschädigungen durch MPH. 15 Fälle waren aufgrund lückenhafter Dokumentation nicht beurteilbar. Bei 25 Verdachtsfällen wurde ein Zusammenhang zwischen der Einnahme von MPH und dem Auftreten von Leberschäden als „unwahrscheinlich“ eingestuft. Ein „möglicher“ kausaler Zusammenhang fand sich bei 11 Fällen, ein „wahrscheinlicher“ kausaler Zusammenhang bei 9 Fällen: Berichtet wurde von jeweils einem Patienten mit fulminanter Hepatitis und größenprogredientem benignen Lebertumor und 18 Fällen mit (reversibler) Leberenzymwerterhöhung. Gemäß unseren Auswertungen ist MPH in Bezug auf Leber- und Gallenerkrankungen gut verträglich.

scholarly journals A STUDY OF AGREEMENT BETWEEN WHO-UPPSALA MONITORING CENTRE CRITERIA, NARANJO ALGORITHM, AND LIVERPOOL ALGORITHM FOR CAUSALITY ASSESSMENT OF ADVERSE DRUG REACTIONS

2021 ◽  
pp. 20-22
Author(s):  
MESSALINE SUNITHA ◽  
SHOBHA PARVATHY
Keyword(s):  
Assessment Tool ◽  
Causality Assessment ◽  
World Health Organisation ◽  
Assessment Tools ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
Kappa Statistics ◽  
Monitoring Centre ◽  
Naranjo Algorithm ◽  
Uppsala Monitoring

Objective: A standard causality assessment tool of an adverse drug reaction (ADR) is essential to compute the risk-benefit assessment of the medication taken by the patient and categorize its relationship likelihood. It should be reproducible and should not differ with the background and experience of the evaluator. Though there are a large number of causality assessment tools, none is unanimously accepted worldwide. So, this study was done to assess the agreement between three frequently used methods of causality assessment, the World Health Organisation-Uppsala Monitoring Centre (WHO-UMC) system, the Naranjo’s algorithm, and the Liverpool algorithm. Methods: 172 ADR forms from the pharmacovigilance unit were randomly selected for the study. Causality assessment was done using three different methods, the WHO-UMC system, Naranjo’s algorithm, and the Liver pool algorithm. Cohen’s Kappa statistics was applied to look for agreement between the causality assessment methods. Results: The agreement between the WHO-UMC criteria and Naranjo’s algorithm was the highest (136), with a Kappa value of 0.511, suggesting a moderate level of agreement. A maximum number of disagreements were noted between the WHO-UMC system and the Liverpool algorithm method (110). Conclusion: A moderate agreement exists between the WHO-UMC system and the Naranjo algorithm. There is poor agreement between the Liverpool algorithm and the other two scales. Therefore, it is recommended that both the WHO-UMC system and the Naranjo algorithm be used for causality assessment of ADRs.

scholarly journals Adverse Drug Reactions in a Complementary Medicine Hospital: A Prospective, Intensified Surveillance Study

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
M. Süsskind ◽  
P. A. Thürmann ◽  
C. Lüke ◽  
E. Jeschke ◽  
M. Tabali ◽  
...  
Keyword(s):  
Adverse Drug Reactions ◽  
Community Hospital ◽  
Safety Data ◽  
Uppsala Monitoring Centre ◽  
Anthroposophic Medicine ◽  
Drug Reactions ◽  
Monitoring Centre ◽  
Medical Wards ◽  
Design And Methods ◽  
Uppsala Monitoring

Background. Anthroposophic medicine is one of the widely used approaches of complementary and alternative medicine. However, few prospective studies have generated safety data on its use.Objectives. We aimed to assess adverse drug reactions (ADRs) caused by anthroposophical medicines (AMEDs) in the anthroposophical Community Hospital Havelhoehe, GERMANY. Study Design and Methods. Between May and November 2007, patients of six medical wards were prospectively assessed for ADRs. Suspected ADRs occurring during hospitalization were documented and classified in terms of organ manifestation (WHO SOC-code), causality (according to the Uppsala Monitoring Centre WHO criteria), and severity. Only those ADRs with a severity of grade 2 and higher according to the CTCAE classification system are described here. Results. Of the 3,813 patients hospitalized, 174 patients (4.6%) experienced 211 ADRs (CTCAE grade 2/3n=191, 90.5%, CTCAE grade 4/5n=20, 9.5%) of which 57 ADRs (27.0%) were serious. The median age of patients with ADRs (62.1% females) was 72.0 (IQR: 61.0; 80.0). Six patients (0.2%) experienced six ADRs (2.8% of ADRs) caused by eight suspected AMEDs, all of which were mild reactions (grade 2).Conclusion. Our data show that ADRs caused by AMEDs occur rarely and are limited to mild symptoms.

Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre

2007 ◽  
pp. 265-275
Author(s):  
I. Ralph Edwards ◽  
Marie Lindquist ◽  
Andrew Bate ◽  
G. Niklas Norn
Keyword(s):  
Data Mining ◽  
Uppsala Monitoring Centre ◽  
Monitoring Centre ◽  
Uppsala Monitoring
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