Adverse drug reactions. Prof. dr. Jolanta Gulbinovič
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1 Adverse drug reactions Prof. dr. Jolanta Gulbinovič
2 Definitions Adverse event Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment [Dir 2001/20/EC Art 2(m)]. An adverse event can therefore be any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product (see GVP Annex IV, ICH-E2D Guideline). Adverse drug reaction A response to a medicinal product which is noxious and unintended An adverse reaction, in contrast to an adverse event, is characterised by the fact that a causal relationship between a medicinal product and an occurrence is suspected. All spontaneous reports notified by healthcare professionals or consumers are considered suspected adverse reactions, since they convey the suspicions of the primary sources, unless the primary source specifically state that they believe the event to be unrelated or that a causal relationship can be excluded. Adverse reactions may arise from use of the product within or outside the terms of the marketing authorisation or from occupational exposure. Use outside the marketing authorisation includes off-label use, overdose, misuse, abuse and medication errors. 11/20/2017 2
3 Serious Adverse Drug reaction An adverse reaction which results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect. 11/20/2017 3
4 Causal relationship Patient Treating physician Marketing authorization holder Medicines Control Agency 11/20/2017 4
5 Contraceptics and thromboembolism Levothyroxine and erythema multiforme MMR vaccine and autism spectrum disorders Spironolactone and gynecomastia Clarithromycin and QTc prolongation 11/20/2017 5
6 Causal relationship Can a medicine cause ADR? Has medicine caused ADR? Will medicine cause ADR? 11/20/2017 6
7 Causality assessment Medical history Information on suspected medicine and other medicines (tratments): Dosage, method of usage, start and end of treatment, time to onset, indication for use Description of adverse effect (clinical data, laboratory data) Treatment course, recovery 11/20/2017 7
8 Evaluation criteria Time dependence Pharmacological plausibility (mechanism of action, symptoms, previous experience, class effect) Medicinal probability (signs and symptoms, laboratory tests, pathological findings) Absence of other causes 11/20/2017 8
9 Conformation of causal relationship Reaction and time relationship Pharmacokinetics Type of reaction Organ affected Dose-effect relationship Dose reduction/discontinuation/dechallenge Rechallenge Known effect of medicine Other concurrent medication Traditional medicines Food supplements 11/20/2017 9
10 Causal relationship(who/umc) 11/20/
11 Frequency of ADRs Very common ( 1/10) Common ( 1/100 to < 1/10) Uncommon ( 1/1,000 to < 1/100) Rare ( 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data) 11/20/
12 Consequences of ADRs 11/20/
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15 Types of ADRs Type A. Dose related Predictable, acute, related to the mechanism of action of medicines B. Dose unrelated Unpredictable (idiosyncratic), no pharmacological plausibility C. Dose and time related Chronic D. Time related Late E. Withdrawal After drug discontinuation F. Unexpected inefficacy Treatment ineffective 11/20/
16 A. Dose related ADRs Signs Examples Action Frequent Similar to pharmacological effect Predictable Rarely lethal Intoxication: Digoxin intoxication, serotonin syndrome with SSRI ADRs: Anticholinergic action of TCA Dose reduction or withdrawal of medicine Assess possible drugdrug interaction 11/20/
17 B. Dose unrelated ADRs Signs Examples Action Uncommon Unrelated to pharmacological action of the medicine Unpredictable Frequently lethal Immunological reactions: Hypersensitivity to penicillin Idiosyncratic reactions: Acute porphyria Malignant hyperthermia Pseudoallergy (ampicillin rash) Discontinue medicine use and never use it again 11/20/
18 Dose-response curve 11/20/
19 Adverse drug effect Primary pharmacological effect Secondary pharmacological effect Enhanced known effect Effect on other organs or systems explained by the mechanism of action Beta blocker - bradycardia Beta-blocker - bronchospasm 11/20/
20 Pharmacologically predictable ADRs 11/20/
21 Physiological, pharmacological and toxicological aspects of metabolism of xenobiotics and endobiotcs 11/20/
22 Cardiotoxic action of terfernadine 11/20/
23 Warfarin, used since 1954 Daily dose (mg) 0,5-20 Dose variability 40 times Risk of major bleedings 2,6/100-patient-years Reporting rate of ADRs 3rd medicine 11/20/
24 Dose variability 11/20/
25 VKORC1 - Vitamin K epoxide reductase complex subunit 1 11/20/
26 Dose variability: clinical factors 11/20/
27 Dose and efficacy variability 11/20/
28 Metabolism of paracetamol A: Healthy individuals, 95% of paracetamol is conjugated with glucuronides which are excreted with urine. Other part is conjugated with glutathione. B: Malnourished patients, conjugation disorder, glutathione depletion accumulation of hepatotoxic metabolite N-acetyl-p-benzoquinonimin 11/20/
29 Grapefruit-drug interaction: forbidden fruit or manageable consequiencies? 11/20/
30 Immune adverse reactions 11/20/
31 Hypersensitivity to medicines Abacavir 11/20/
32 HLA-B*5701 genotype and hypersensitivity to abacavir 11/20/
33 Association of HTA alleles with DILI Kindmark et al., 2008; Daly et al., 2009; Donaldson et al., 2010; Kamali et al., 2009; Hirata et al., 2008; Singer, /20/
34 ADRs reports in Lithuania 11/20/
35 Individual case safety reports EudraVigilance data base receives about ICSR per month 11/20/
36 What to do with ISCR? Can one report alter benefit risk balance of the product? Can a medicinal product be withdrawn from the market due to one report? How many reports are needed to change B-R balance? 11/20/
37 Signal Information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature /20/2017
38 Timeline from detection of signal to its conformation 38 11/20/2017
39 Signal detection 39 IC information component 11/20/2017 A. Bate, UMC
40 Data mining ; disproportionality 40 11/20/2017
41 Consequencies Withdrawal of MA Suspension of MA DHPC Variation to MA None 11/20/
42 11/20/2017 McNaughton R. BMJ Open
43 11/20/
44 Suspension/withdrawal of MA Tetrazepam TEN Ketoconazole (fungal indication) hepatotoxicity; (current indication endogenous Cushing syndrome) Fusafungine serious allergic reactions Gadolinium preparations (lineal) Restricted indications nicergoline, trimethazidine, metoclopramide, stroncium ranelate, hydroxyethyl starch, domperidon, ivabradine, valproates Other variation to MA RAS (ACEI and ARB combination)... 11/20/
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46 Figure 1: Axial T1-weighted MR images through, A, C, E, basal ganglia and, B, D, F, posterior fossa at level of dentate nucleus. Images are shown for, A, B, control group patient 4, and the, C, D, first and, E, F, last examinations performed in contrast group patient 13. Regions of interest used in quantification of signal intensity are shown as dashed lines for globus pallidus (green), thalamus (blue), dentate nucleus (yellow), and pons (red). Radiology, Published in: Robert J. McDonald; Jennifer S. McDonald; David F. Kallmes; Mark E. Jentoft; David L. Murray; Kent R. Thielen; Eric E. Williamson; Laurence J. Eckel; Radiology 2015, 275, DOI: /radiol by the Radiological Society of North America, Inc. One PowerPoint slide of each figure may be downloaded and used for educational, non-promotional purposes by an author for slide presentations only. The RSNA citation line must appear in at least 10-point type on all figures in all presentations. Pharmaceutical and Medical Education companies must request permission to download and use slides, and authors and/or publishing companies using the slides for new article creations for books or journals must apply for permission. For permission requests, please contact the publisher at
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49 DHPC laiškai gydytojams 11/20/
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51 Pranešimai apie NRV 11/20/
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57 Rizika ir jos mažinimas 11/20/
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