scholarly journals Headache as an Adverse Reaction to the Use of Medication in the Elderly: A Pharmacovigilance Study

Author(s):  
Cristina Monteiro ◽  
Beatriz Dias ◽  
Maria Vaz-Patto

There is a consensus that elderly individuals are quite vulnerable to adverse drug reactions (ADRs), and headaches are one of the most frequent clinical presentations of central nervous system problems in the general population, which can be an ADR. The purpose of our work was to analyze reports of “headache” associated ADRs in the elderly sent to the Portuguese Pharmacovigilance System (PPS), and also which drugs were more frequently associated with this adverse reaction. A retrospective analysis of suspected ADR reports involving patients aged 65 years or older received by the PPS in the last 10 years was conducted. A search of all the terms associated with the High Level Term “headache” was performed. All duplicate reports were excluded from the analysis. A total of 155 ADRs reports were included, in which 15 reported isolated “headache” as suspected ADR, while the remaining 140 ADRs reports reported “headache” together with several other adverse reactions. Most reports of “headache” ADR occurred in women (74.8%; n = 116). About half (46.5%; n = 72) of the ADR reports were considered serious. Anti-viral medication, anti-depressants, anti-dyslipidemic agents and central nervous system-acting analgesics were the most frequent drugs associated with “headache” ADR reports in this population. In elderly patients, most ADR reports involving headaches occurred in women and a high percentage (46.5%) were considered serious. Thus, it is important that healthcare professionals pay more attention to headaches reported as ADRs in the elderly and drugs suspected to cause them, in order to increase knowledge about this type of reaction and contribute towards safely using drugs in this age group.

Author(s):  
Kamila Sienkiewicz ◽  
Monika Burzyńska ◽  
Izabela Rydlewska-Liszkowska ◽  
Jacek Sienkiewicz ◽  
Ewelina Gaszyńska

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.


2003 ◽  
Vol 25 (4) ◽  
pp. 200-205 ◽  
Author(s):  
Elisaldo Luiz de Araújo Carlini ◽  
Solange Aparecida Nappo

OBJETIVE: The present study aimed to analyze 219 notifications of suspected adverse reactions (AR) produced by psychoactive medicaments (ARPM), notified by Brazilian psychiatrists, during a 3-month period (April 1999 up to September 2001). METHOD: A notifying card for adverse reactions possibly produced by psychoactive medications was quarterly sent to all psychiatrists affiliated to the Brazilian Association of Psychiatry. Once each notification, dully filled in, was received, the possible adverse reaction was analyzed in order to verify the causality RESULTS: The psychiatrists classified as severe 50 of the ARPMs; 150 others were not considered as severe. Among the severe ones there were 3 deaths, 12 life-threatening reactions, 26 ARPMs required or prolonged hospitalization and 9 notifications described temporary disability of the patients. Among the medications, antidepressants ranked first with 122 ARPMs being notified, followed by neuroleptics (46 ARPMs) and antiepiletic medicaments (25 ARPMs). The three main organs and systems affected by the ARs were the Central Nervous System with 102 ARs, skin and mucosa with 44 and gastrointestinal with 21 ARPMs. CONCLUSION: Considering causality, i.e., the association between the medication and the described AR, 24 cases were considered as Definite (with positive dechallenge and rechallenge, i.e., withdrawal and reintroduction of the medication) and 134 other ARPMs were classified as Probable (only dechallenge positive; only with medication withdrawal; rechallenge was not performed).


2020 ◽  
Vol 22 (Supplement_3) ◽  
pp. iii329-iii330
Author(s):  
Hiroaki Motegi ◽  
Shigeru Yamaguchi ◽  
Yukitomo Ishi ◽  
Michinari Okamoto ◽  
Akihiro Iguchi ◽  
...  

Abstract BACKGROUND Primary central nervous system(CNS) choriocarcinoma(CC) is very rare and has the poorest prognosis among germ cell tumor (GCT). CC usually has extremely high level (HL) of serum beta-human chorionic gonadotropin (bhCG) over than 1,000 mIU/ml. Some studies assign HL bhCG cases to poor prognosis group even without biopsy. The purpose of this study was to find out if there was a good prognosis subset in the HL bh group. MATERIALS AND METHODS We analyzed 103 cases diagnosed with GCT from 1998 to 2019 in Hokkaido University Hospital and reviewed the literature of CNS CC and bhCG. Survival was assessed using Kaplan-Meier method and log-rank statistics between the group with CC component and that with no CC component but HL bhCG. RESULTS One out of 103 our cases was diagnosed as a mixed GCT with CC component and did not respond to treatment and died 9 months later. Two cases were treated as CC because of HL bhCG (1,226 and 2,739 mIU/ml) despite that the biopsy showed only germinomas and survived(105 and 37 months), that is, no CC component. Combining our cases with 69 cases in the literature, all 7 cases with no CC component but HL bhCG survived but the median survival of the other 65 cases with CC component was 38.2 months (P=0.02). CONCLUSION This study has a limitation of selection bias, however, it suggests that patients with no CC component but HL bhCG may have a better prognosis.


2021 ◽  
Vol 14 (11) ◽  
pp. e245341
Author(s):  
Uddalak Chakraborty ◽  
Shrestha Ghosh ◽  
Amlan Kusum Datta ◽  
Atanu Chandra

The spectrum of central nervous system demyelinating disorders is vast and heterogeneous and, often, with overlapping clinical presentations. Misdiagnosis might occur in some cases with serious therapeutic repercussions. However, introduction of several new biomarkers such as aquaporin-4 IgG and myelin oligodendrocyte glycoprotein IgG has made distinction between diseases such as multiple sclerosis and myelin oligodendrocyte glycoprotein antibody-associated disorder easier. Here, we report a case of a 15-year-old male patient with subacute multifocal neurological presentation without encephalopathy, eventually diagnosed as myelin oligodendrocyte glycoprotein antibody-associated disorder.


2007 ◽  
Vol 85 (2) ◽  
pp. 207-211 ◽  
Author(s):  
Antonio M. P. Omuro ◽  
Luc Taillandier ◽  
Olivier Chinot ◽  
Charlotte Carnin ◽  
Maryline Barrie ◽  
...  

2021 ◽  
Vol 10 (4) ◽  
pp. 30-36
Author(s):  
A. A. Makarova ◽  
O. A. Kharkova

Objective: to study the role of personal anxiety in the development of psychophysiological indicators in adolescent athletes.Materials and methods. To study the prevalence of high levels of personal anxiety (hereinafter — LT), as well as to determine the characteristics of psychophysiological indicators, the study involved 23 teenagers — boys and girls who were representatives of different sports. Using the device for psychophysiological testing UPFT-1/30 “Psychophysiologist”, indicators of simple visual-motor reaction and the level of LT on the Spielberg scale were obtained. To assess the impact of changes in high LT levels on psychophysiological indicators, 14 adolescent athletes with a high level of personal anxiety were selected and then divided into 2 groups. The experimental group included adolescents who wanted to participate in an experiment on the use of cognitive behavioral therapy techniques to correct high LT levels; the control group included adolescents with high LT levels who were not trained in cognitive behavioral therapy techniques.Results. Every third adolescent athlete had a high level of LT. Adolescent athletes with a high LT level, in contrast to adolescents with an optimal LT level, were less efficient, and, despite a shorter minimum reaction time, made more mistakes. The dynamics of psychophysiological indicators were observed both in the group with intervention and in the group where no cognitive behavioral therapy techniques were performed; however, after studying the difference in the physiological parameters of the central nervous system in the group where there was a change in LT, and in the group where LT either did not change or increased, we found positive changes. Changes in the LT level led to a decrease in the average reaction time, the minimum reaction time, and an increase in the level of stability of reactions.Conclusions. A high level of LT affects the psychophysiological parameters of the central nervous system in adolescent athletes. The use of cognitive behavioral therapy techniques to normalize the LT level of adolescent athletes leads to an improvement in the physiological parameters of the central nervous system.


2020 ◽  
Vol 12 (3) ◽  
pp. 359-364
Author(s):  
Zohaib Yousaf ◽  
Mohammed Yaseen Ahmed Siddiqui ◽  
Kamran Mushtaq ◽  
Sayeda Efath Feroz ◽  
Mohamed Aboukamar ◽  
...  

COVID-19 has a broad spectrum of clinical presentations, including central nervous system manifestations that are not uncommon. The high pretest probability of COVID-19 in pandemic can lead to anchoring. We present a patient of COVID-19 pneumonia who presented with dyspnea and acute confusional state. His initial workup was suggestive of tuberculous meningoencephalitis with lymphocytic pleocytosis, high protein in CSF analysis, and suspicious MRI findings, which was later confirmed with a positive CSF culture. To the best of our knowledge, it is the first such case. Anchoring to the diagnosis of COVID-19 may deter clinicians from considering other concurrent diagnoses and a poor outcome consequently.


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