scholarly journals Adverse events reported for hereditary angioedema medications: a retrospective study of spontaneous reports submitted to the EudraVigilance database, 2007-2013

2016 ◽  
pp. 1
Author(s):  
Lise Aagaard ◽  
Anette Bygum
Keyword(s):  
Retrospective Study ◽  
Adverse Events ◽  
Hereditary Angioedema ◽  
Spontaneous Reports

Predicting early post-chemotherapy adverse events in patients with hematological malignancies: a retrospective study

2016 ◽  
Vol 24 (6) ◽  
pp. 2727-2733
Author(s):  
Xiaoming Fei ◽  
Fang Lei ◽  
Haifeng Zhang ◽  
Hua Lu ◽  
Yan Zhu ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Adverse Events ◽  
Hematological Malignancies

Tocilizumab in Giant Cell Arteritis: A Multicenter Retrospective Study of 34 Patients

2016 ◽  
Vol 43 (8) ◽  
pp. 1547-1552 ◽  
Author(s):  
Alexis Régent ◽  
Serge Redeker ◽  
Alban Deroux ◽  
Pierre Kieffer ◽  
Kim Heang Ly ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Side Effects ◽  
Adverse Events ◽  
Giant Cell Arteritis ◽  
Giant Cell ◽  
Multicenter Study ◽  
Efficacy And Safety ◽  
Severe Adverse Events ◽  
Retrospective Multicenter Study

Objective.To report the efficacy and safety of tocilizumab (TCZ) for giant cell arteritis (GCA).Methods.A retrospective multicenter study that included 34 patients receiving TCZ for GCA.Results.TCZ was effective in all but 6 patients, who still had mild symptoms. Mean glucocorticoid dose was tapered. One patient died and 3 patients had to stop TCZ therapy because of severe adverse events. Twenty-three patients stopped treatment; 8 of these experienced relapses after a mean of 3.5 ± 1.3 months.Conclusion.TCZ is effective in GCA. However, side effects occur. Whether this treatment has only a suspensive effect remains to be determined.

scholarly journals Congenital cardiac interventions during the peak phase of COVID-19 pandemics in the country in a pandemics hospital in Istanbul

2020 ◽  
Vol 30 (9) ◽  
pp. 1288-1296
Author(s):  
Murat Ugurlucan ◽  
Yahya Yildiz ◽  
Didem Melis Oztas ◽  
Senay Coban ◽  
Metin Onur Beyaz ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Adverse Events ◽  
Hospital Stay ◽  
Surgical Procedures ◽  
Interventional Procedures ◽  
Preventive Measures ◽  
Cardiovascular Disorders ◽  
Cardiac Disorders ◽  
Corrective Procedures ◽  
Peak Phase

AbstractIntroduction:In this report, we aim to present our algorithm and results of patients with congenital cardiac disorders who underwent surgical or interventional procedures during the peak phase of the pandemics in our country.Patients and methods:The first COVID-19 case was diagnosed in Turkey on 11 March, 2020, and the peak phase seemed to end by the end of April. All the patients whom were referred, treated, or previously operated but still at the hospital during the peak phase of COVID-19 pandemics in the country were included into this retrospective study. Patient’s diagnosis, interventions, adverse events, and early post-procedural courses were studied.Results:Thirty-one patients with various diagnoses of congenital cardiovascular disorders were retrospectively reviewed. Ages of the patients ranged between 2 days and 16 years. Seventeen cases were males and 14 cases were females. Elective cases were postponed. Priority was given to interventional procedures, and five cases were treated percutaneously. Palliative procedures were preferred in patients whom presumably would require long hospital stay. Corrective procedures were not hesitated in prioritised stable patients. Mortality occurred in one patient. Eight patients out of 151 ICU admissions were diagnosed with COVID-19, and they were transferred to COVID-19 ICU immediately. Three nurses whom also took care of the paediatric cases became infected with SARS-CoV-2; however, the children did not catch the disease.Conclusion:Mandatory and emergent congenital cardiac percutaneous and surgical procedures may be performed with similar postoperative risks as there are no pandemics with meticulous care and preventive measures.

scholarly journals Adverse events of intravenous immunoglobulin infusions: a ten-year retrospective study

2013 ◽  
Vol 3 (4) ◽  
pp. 249 ◽  
Author(s):  
Frances Rose R. Palabrica ◽  
Shirley L. Kwong ◽  
Florecita R. Padua
Keyword(s):  
Retrospective Study ◽  
Adverse Events ◽  
Intravenous Immunoglobulin

scholarly journals Major Aspects of Detection and Monitoring of Adverse Reactions Associated with Cephalosporin Antibiotic Treatment

2021 ◽  
Vol 9 (1) ◽  
pp. 34-42
Author(s):  
E. Yu. Demchenkova ◽  
G. I. Gorodetskaya ◽  
I. A. Mazerkina ◽  
M. V. Zhuravleva ◽  
A. S. Kazakov ◽  
...  
Keyword(s):  
Adverse Events ◽  
Adverse Drug Reactions ◽  
Patient Information ◽  
Adverse Reactions ◽  
Stevens Johnson Syndrome ◽  
Drug Reactions ◽  
Patient Information Leaflets ◽  
Information Leaflets ◽  
Spontaneous Reports ◽  
Cephalosporin Antibiotics

Widespread use of cephalosporin antibiotics in clinical practice calls for greater attention to the risk of adverse drug reactions. Information on serious or unexpected adverse events reported during post-marketing experience is submitted to national and international pharmacovigilance databases. Analysis of these reports helps to identify new adverse drug reactions.The aim of the study was to analyse the safety profile of cephalosporin antibiotics based on spontaneous reports in the international VigiBase database.Materials and methods: the analysis of the adverse reaction profile of cephalosporin antibiotics was based on MedDRA system organ classes and included spontaneous reports submitted to VigiBase from the moment of its creation until August 2020.Results: the authors identified the most clinically significant adverse reactions for different cephalosporin generations. They compared and analysed information on adverse events in VigiBase and in patient information leaflets of medicinal products authorised in the Russian Federation. It was demonstrated that some serious events described in VigiBase spontaneous reports for V-generation cephalosporins are not included in the “Side effects” section of the patient information leaflets. According to VigiBase, the use of ceftaroline was associated with the development of generalised exfoliative dermatitis, Stevens–Johnson syndrome, tubulointerstitial nephritis, while the use of ceftolozane was associated with acute kidney injury, renal insufficiency, sepsis, pneumonia, and respiratory insufficiency.Conclusion: reporting of unexpected and serious adverse drug reactions to cephalosporin antibiotics is an important task of healthcare practitioners. Availability of information on class-specific and generation-specific serious adverse reactions will help predict and prevent their development.

scholarly journals Adverse Events Associated with Nifurtimox Treatment for Chagas Disease in Children and Adults

2020 ◽  
Author(s):  
A. J. Berenstein ◽  
N. Falk ◽  
G. Moscatelli ◽  
S. Moroni ◽  
N. González ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Adverse Events ◽  
Chagas Disease ◽  
Adverse Drug Reactions ◽  
Drug Tolerance ◽  
Drug Reactions ◽  
Safety Concerns ◽  
Scarce Data

BACKGROUND: Nifurtimox (NF) is one of the only two drugs currently available for Chagas disease (ChD) treatment. However, there is scarce data on NF safety, and many physicians defer or refuse NF treatment because of concerns about drug tolerance. METHODS: Retrospective study of adverse drug reactions (ADRs) associated with NF treatment of ChD. Children received NF doses of 10-15 mg/kg/day for 60-90 days, and adults 8-10 mg/kg/day for 30 days. Results: 215 children (median age: 2.6yrs, range 0-17) and 105 adults (median age: 34yrs, range 18-57) were enrolled. Overall, 127/320 (39.7%) patients developed ADRs, with an incidence of 64/105 in adults, and 63/215 in children (OR = 3.7, 95%CI [2.2;6.3]). We observed 215 ADRs, 131 in adults (median: 2 events/patient (IQR25-75= 1-3) and 84 in children (median: 1 event/patient (IQR25-75= 1-1.5) (PAdjusted < 0.001). ADRs were mainly mild and moderate. Severe ADRs were infrequent (1.2% in children and 0.9% in adults). Nutritional, central nervous and digestive systems were the most frequently affected, without differences between both groups. Treatment was discontinued in 31/320 (9.7%) patients without differences between groups. However, ADR-related discontinuations occurred more frequently in adults than in children (OR = 5.5, 95%CI = [1.5;24]). CONCLUSIONS: Our study supports the safety of NF for ChD treatment. Delaying NF treatment due to safety concerns does not seem to be supported by the evidence.

scholarly journals Sedation Protocol During Bevacizumab Intravitreal Injection in Preterm Infants With Retinopathy of Prematurity

2018 ◽  
Vol 23 (1) ◽  
pp. 34-40
Author(s):  
Jamie L. Miller ◽  
Peter N. Johnson ◽  
Kari Harkey ◽  
R. Michael Siatkowski
Keyword(s):  
Retrospective Study ◽  
Data Collection ◽  
Adverse Events ◽  
Retinopathy Of Prematurity ◽  
Intravitreal Bevacizumab ◽  
Primary Objective ◽  
Future Studies ◽  
Sedation Protocol ◽  
Number Of Patients ◽  
Sedation And Analgesia

OBJECTIVES This study describes outcomes of intravenous (IV) analgesics and sedatives for bedside intravitreal bevacizumab injections for retinopathy of prematurity. METHODS This retrospective study included infants receiving intravitreal bevacizumab injections between January 2012 and May 2016. Infants were excluded if bevacizumab was administered under general anesthesia or for incomplete records. Data collection included demographics, sedation and analgesia regimen, and cardiopulmonary adverse events (AEs). The primary objective was to identify the median doses of the IV analgesics and sedatives. The secondary objectives included the number of patients with cardiopulmonary AEs and those with procedure success, defined as procedure completion without interruption and absence of interventions. RESULTS Fifteen infants were included. Fourteen (93.3%) were initiated on a fentanyl infusion at a median of 2 mcg/kg/hr (IQR, 2–3.6), and 12 (80%) received midazolam infusions at a median of 0.06 mg/kg/hr. All patients received at least 1 IV neuromuscular blocker dose just prior to the procedure. Only 2 patients (13.3%) required an increase in their fentanyl or midazolam infusions. Procedure success was achieved in 13 patients (86.7%). Five patients (33.3%) experienced 1 cardiopulmonary AE. One patient (6.7%) had a delay in the procedure, and 1 patient (6.7%) required naloxone. Despite this, the procedure was completed in all patients. CONCLUSIONS Most received fentanyl and midazolam infusions with a dose of vecuronium just prior to the procedure. Thirteen (86.7%) met the criteria for procedure success. One-third experienced a cardiopulmonary AE. Future studies are needed to identify the optimal agents and route of administration for this procedure.

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