Number Of Adverse Reaction Reports Research Articles

Adverse reaction signals mining and hemorrhagic signals comparison of ticagrelor and clopidogrel: A pharmacovigilance study based on FAERS.

Background: Ticagrelor and clopidogrel are commonly used antiplatelet agents, and we conducted a pharmacovigilance analysis using the Food and Drug Administration Adverse Event Reporting System (FAERS) to provide a reference for safe and reasonable clinical use. Methods: Data were collected in FAERS from 2012 Q1 to 2022 Q2 for data cleaning. We used system organ classes (SOCs) and prefer terms (PTs) from the Medical Dictionary of Regulatory Activity (MedDRA version 25.1). Adverse event reports were retrieved at the PT level. Adverse reaction (ADR) signals of ticagrelor and clopidogrel were mined by calculating reporting odds ratios (ROR), proportional reporting ratios (PRR), information component (IC) and empirical Bayesian geometric mean (EBGM). After that, further analysis of the hemorrhagic signals and their clinical information were performed. Results: The number of ADR reports where the primary suspect (PS) drugs were 15,133 for ticagrelor and 23,860 for clopidogrel. Significant ADR signals were identified by the SOC analysis for ticagrelor including cardiac disorders (ROR 4.87, PRR 4.46), respiratory disorders (ROR 2.45, PRR 2.28), and vascular disorders (ROR 2.22, PRR 2.16). Clopidogrel included blood disorders (ROR 2.86, PRR 2.77), vascular disorders (ROR 2.71, PRR 2.61), and cardiac disorders (ROR 2.29, PRR 2.22). At the PT level, the more frequent ADR signals for ticagrelor were dyspnoea, contusion, and haemorrhage, while clopidogrel were gastrointestinal haemorrhage, anaemia, and drug interaction. The hemorrhagic signals of both were mainly focused on the SOC level of gastrointestinal disorders, injury disorders and vascular disorders and nervous system disorders. The death and life-threatening rate of ticagrelor was 7.76 percentage higher than that of clopidogrel. Conclusion: Clinicians need to pay attention to not only common ADRs but also be alert to new ADR signals when choosing to use ticagrelor and clopidogrel. This study provides a reference for the reasonable and safe clinical use of ticagrelor and clopidogrel.

The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process.

All medicinal products authorized in the European Union are subjects of constant drug-safety monitoring processes. It is organized in a pharmacovigilance system that is designed to protect human health and life by the detection, analysis and prevention of adverse drug reactions (ADRs) and other drug-related problems. The main role of the aforementioned system is to collect and analyze adverse drug reaction reports. Legislation introduced several years ago allowed patients, their legal representatives and caregivers to report adverse drug reactions, which caused them to be an additional source of safety data. This paper presents the analysis of EudraVigilance data related to adverse drug reactions provided by patients, their representatives, as well as those obtained from healthcare professionals related to medicines which belong to M01A anti-inflammatory and antirheumatic products, a non-steroid group. The objective of the study was to identify the changes in the number and structure of adverse reaction reporting after the introduction of pharmacovigilance (PV) obligations in EU. A review of scientific literature was also conducted to assess the differences in adverse reactions reported by patients or their representatives and by healthcare professionals. We also identified other factors which, according to literature review, influenced the number of adverse reaction reports provided by patients. Analysis of data collected from the EudraVigilance showed that from 2011 to 2013 the number of reports made by patients and their caregivers increased by approx. 24 percentage points, and then, from 2014, it constituted around 30% of the total of reported reactions every year, so patient reporting is an important part of pharmacovigilance system and a source of drugs’ safety information throughout their use in healthcare practice. Additionally, there was no interrelationship between the seriousness of reported adverse reactions and the overall number of patient reports when compared to reports form healthcare professionals.

The effect of television and print news stories on the nocebo responding following a generic medication switch

Following a nationwide switch to a generic antidepressant, a series of negative media stories publicised the experiences of some patients having side effects following the switch. This occurred first in print media and five months later it occurred again in television news. In this study we examined the effect of television news stories compared to print stories on adverse drug reaction reporting. We also examined the change in reporting rate of specific side effects mentioned in the TV news bulletins. Using an interrupted time series analysis of data from a national adverse reactions database, we compared the number of adverse reaction reports after the print and television coverage and the changes in reporting rate of side effects mentioned and not mentioned in TV news stories. We found a significant increase in adverse reaction reports following TV news items that discussed patients' reports of side effects following the medication switch (interruption effect = 73.25, p = .046). The reporting rate of symptoms mentioned in the TV news bulletins also increased, in particular suicidal thoughts (interruption effect = 23.60, p = .031). The effect of TV stories on adverse reaction reports was 211% greater than the print articles. Television stories have a much stronger effect than print media on nocebo responding and specific symptoms mentioned in the bulletins have a direct influence on the type of side effects subsequently reported. Media guidelines should be developed to reduce the negative public health effects of media coverage following medication switches.

Clinical characteristics of adverse events associated with therapeutic monoclonal antibodies in Korea.

The use of monoclonal antibodies (mAbs) is increasing in various clinical fields. Although mAb safety must be demonstrated prior to approval, targeted pharmacovigilance is essential for the recognition and assessment of adverse reactions. The purpose of this study was to identify the major clinical features of adverse reactions to mAbs in Korea. Spontaneous reports of adverse reactions attributed to 18 mAbs from January 2005 to December 2014 were extracted from the Korea Adverse Event Reporting System. We analyzed these reports for information relating to patient characteristics and the types of adverse reactions. In total, 11 492 adverse reactions were reported in 7569 patients. Almost 19% of total study population showed suspected hypersensitivity reactions. Leukocyte abnormalities were reported frequently (10.0%), as well as infections (9.5%), drug eruptions (7.5%), and pruritus (5.0%). Furthermore, 3716 of the adverse reactions in 2538 patients were classified as serious; these included severe infections (18.2%), neutropenia (12.1%), visual dysfunctions (6.6%), and anaphylaxis (4.8%). The mAbs with the highest number of adverse reaction reports were rituximab (27.6%), adalimumab (17.5%), cetuximab (11.9%), and infliximab (10.7%). Hypersensitivity reactions were observed more frequently than expected, although no previously unrecognized reactions were observed. Adverse reactions occurred more frequently in children and in elderly patients. Close monitoring of adverse reactions to therapeutic mAbs is therefore warranted because these can potentially cause serious medical conditions or death. Copyright © 2016 John Wiley & Sons, Ltd.

The number of adverse reaction reports associated with levothyroxine sodium received by CARM has decreased in recent months,

The number of adverse reaction reports associated with levothyroxine sodium received by CARM has decreased in recent months,

Spontaneous Reporting of Adverse Drug Reactions

Drug regulatory authorities in many developed countries have established spontaneous adverse reaction reporting schemes to monitor drug safety [1]. The United Kingdom yellowcard system, organised by the Committee on the Safety of Medicines (CSM), is one of the oldest and the most successful of these national schemes. With typical Anglo-Saxon self-deprecation however, both the medical profession and the lay press have tended to emphasise the limitations of the yellow-card scheme at the expense of its achievements. Spontaneous reporting schemes do indeed have substantial limitations [2]. Firstly, they rely on doctors reporting suspected (and not necessarily proven) adverse reactions. Few adverse reactions, however, are uniquely iatrogenic and an efficient spontaneous reporting scheme depends on doctors' professional skill and judgement in associating their patient's diseases with the drug(s) they have taken. Such schemes are therefore inherently more likely to detect those adverse reactions which occur soon after the start of treatment, and which produce syndromes commonly having an iatrogenic basis such as anaphylactoid reactions, dystonia-dyskinesias and various dermatoses. Conversely, reactions which have a long latency, or which are expressed as conditions only rarely having a recognised iatrogenic basis, may remain unrecognised by this technique. The delayed recognition of the oculomucocutaneous syndrome with practolol is a clear example of this. Secondly, in the United Kingdom (as elsewhere), only a small proportion of even serious adverse drug reactions are reported to the CSM [3]. Underreporting not only results in a substantial loss of useful scientific data, but may also lead to serious bias since reporting rates are conditioned both by manufacturers' promotional claims and by adverse publicity in the medical literature or the media. Thirdly, reporting rates tend to decline with time after a product has been marketed. To some extent this is inevitable: whilst the CSM asks doctors to report all suspected adverse reactions for newly (within three years) marketed drugs, it asks to be notified of only serious reactions to older ones since it would be unnecessarily burdensome (and of little real value) for doctors to continue indefinitely reporting bradycardia with digoxin, nausea with morphine, or dyspepsia with aspirin. Unfortunately, reporting rates of even serious reactions fall off with time. Thus, Inman [4] showed in 1977 that only five out of 44 (11 per cent) of patients dying from blood dyscrasias associated with phenylbutazone or oxyphenbutazone were reported to the CSM; and between 1964 and 1985 there have been only 192 reports [5] of gastrointestinal bleeding or perforation with aspirin! The number of adverse reaction reports for a particular drug will be a function of its usage, as well as its inherent toxicity. The evaluation of spontaneous reporting rates must therefore take into account the size of the exposed population. In the United Kingdom, reporting rates are