Adverse drug reactions

Collette, D; Pa, Thürmann

doi:10.1055/s-2002-28320

Cited by 3 publications

(1 citation statement)

References 12 publications

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“…Unerwünschte hepatotoxische Wirkungen durch APN-Mittel sind in vielerlei Hinsicht miteinander vergleichbar und umfassen Übereinstimmungen bezüglich des natürlichen Verlaufs der Schädigung [4, 7, 9, 21, 41], der Enzymdiagnostik [4, 9, 16,17,23,41,43], der laborchemischen Schädigungstypisierung [1,4,7,9,16,17,41] und meist auch der histopathologischen Befunde [1,4,9,21]. Gemeinsamkeiten gibt es auch bei der Rolle von Zytochrom P450 und seinen Isoenzymen beim Abbau und Interaktionspotenzial zahlreicher 8,12,34,[56][57][58][59][60], wobei auch mçgliche Probleme im Rahmen der Pharmakogenetik zu diskutieren sind [61 -64]. Immerhin wird eine Vielzahl von Fremdsubstanzen im endoplasmatischen Retikulum der Leberzelle in der Phase I durch Oxidation umgewandelt, damit deren Metabolite in einer späteren Phase II sowohl im endoplasmatischen Retikulum als auch im Zytosol der Leberzelle konjugiert und damit über die Nieren oder die Galle ausgeschieden werden kçnnen [4,12].…”

Section: Einheitliche Prüfung Der Kausalitätunclassified

Toxische Leberschäden durch arzneiliche, pflanzliche und nahrungsergänzende Mittel: Diagnostische Möglichkeiten

Teschke

Schwarzenböck²,

Kh³

2007

Z Gastroenterol

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Toxic liver diseases caused by drugs, herbs and dietary supplements are often recognized late because their hepatotoxic potency is considered to be minimal or non-existent and specific laboratory parameters to definitively establish the diagnosis are lacking. As gold standard for the diagnosis, a positive (unintentional) re-exposure test is considered which is seldom available. A system for evaluation is therefore necessary which takes into account various parameters and defines the grades of causality. By means of a qualitative pre-test with a few questions a screening may be possible as to whether the causality is not probable or not evaluable. Subsequently, a quantitative assessment of the degree of the causality with a main test should be done; this corresponds to the slightly modified and well validated score of the CIOMS (Council for International Organizations of Medical Sciences). The evaluation is achieved using various criteria such as latency period, time between the end of the therapy and begin of the reaction, course of values for the enzyme activities of the liver after cessation of the therapy, risk factors such as age, alcohol consumption and comedication, exclusion of diseases of other organs including chronic liver disease, previous information about hepatotoxicity of the alleged substance and possible results of an unwanted re-exposure. The various answers to these questions are quantitatively assessed, the resulting scores added, and finally an assignment to one of the grades of causality is made. If, on the basis of the main test, there are still doubts about the correct diagnosis, a further test is required to consider the differential diagnosis of additional diseases and chronic liver diseases of other causes. This stepwise approach is essential since ad-hoc decisions regarding causality are not without problems, and other diseases as causes for increased liver values are easily overlooked and not treated adequately in time. By means of this procedure an improvement in the drug safety can be expected, which is fruitful for the patient and helpful to the physician in charge, the health institutions and the drug companies.

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Section: Einheitliche Prüfung Der Kausalitätunclassified

Toxische Leberschäden durch arzneiliche, pflanzliche und nahrungsergänzende Mittel: Diagnostische Möglichkeiten

Teschke

Schwarzenböck²,

Kh³

2007

Z Gastroenterol

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Unerwünschte Arzneimittelwirkungen

Thürmann

2006

Pathologe

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Adverse drug reactions (ADR) occur in about 5% of all pharmacologically treated patients. Between 2% and 20% of all hospital admissions are caused by ADR, and approximately 10% of all hospitalized patients experience ADR during their hospital stay. Several thousand patients die due to ADR in Germany each year. ADR-associated drugs come predominantly from the class of non-steroidal antiinflammatory drugs, anticoagulants, acetylsalicylic acid and cardiovascular drugs. Most ADR cases present as gastrointestinal bleeding and adverse cardiovascular effects. Apart from this, one or more drugs are withdrawn from the market each year because of unwanted but mostly rare side effects. In recent years the most prominent cases were rofecoxib, cisapride and cerivastatin. Physicians in Germany are obliged to report ADR. A substantial proportion of ADR, however, is not reported because it is deemed to be either too well known or the association between the drug and the adverse effect is too doubtful. In some cases, histopathological findings are needed to determine the diagnosis of ADR. Accordingly, physicians should inform the pathologist whether an ADR is suspected and which drugs may be responsible.

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