scholarly journals Serious Adverse Events Associated With Hydroxychloroquine Amidst COVID-19 Pandemic: Case Series and Literature Review

Cureus ◽  
2020 ◽  
Author(s):  
Ramy Abdelmaseih ◽  
Randa Abdelmasih ◽  
Mustajab Hasan ◽  
Srikanth Tadepalli ◽  
Jigar Patel
Keyword(s):  
Literature Review ◽  
Adverse Events ◽  
Case Series ◽  
Serious Adverse Events

scholarly journals Safety of alemtuzumab in a nationwide cohort of Finnish multiple sclerosis patients

2021 ◽  
Author(s):  
Ilkka Rauma ◽  
Tiina Mustonen ◽  
Juha Matti Seppä ◽  
Maritta Ukkonen ◽  
Marianne Männikkö ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Case Series ◽  
Retrospective Case ◽  
Serious Adverse Events ◽  
Highly Active ◽  
Disease Modifying Therapy ◽  
Case Series Study ◽  
Multiple Sclerosis Patients

Abstract Background Alemtuzumab is an effective disease-modifying therapy (DMT) for highly active multiple sclerosis (MS). However, safety concerns limit its use in clinical practice. Objectives To evaluate the safety of alemtuzumab in a nationwide cohort of Finnish MS patients. Methods In this retrospective case series study, we analyzed the data of all but two MS patients who had received alemtuzumab in Finland until 2019. Data were systematically collected from patient files. Results Altogether 121 patients were identified, most of whom had received previous DMTs (82.6%). Median follow-up time after treatment initiation was 30.3 months and exceeded 24 months in 78 patients. Infusion-associated reactions (IARs) were observed in 84.3%, 57.3%, and 57.1% of patients during alemtuzumab courses 1–3, respectively. Serious adverse events (SAEs) were observed in 32.2% of patients, serious IARs in 12.4% of patients, and SAEs other than IARs in 23.1% of patients. Autoimmune adverse events were observed in 30.6% of patients. One patient died of hemophagocytic lymphohistiocytosis, and one patient died of pneumonia. A previously unreported case of thrombotic thrombocytopenic purpura was documented. Conclusions SAEs were more frequent in the present cohort than in previous studies. Even though alemtuzumab is a highly effective therapy for MS, vigorous monitoring with a long enough follow-up time is advised.

Successful Use of Intravenous Methylnaltrexone for Opioid-Induced Constipation in Critically Ill Pediatric Patients

2021 ◽  
Author(s):  
Kimberly P. Mills ◽  
Christopher C. McPherson ◽  
Ahmed S. Said ◽  
Michael A. Lahart
Keyword(s):  
Adverse Events ◽  
Critically Ill ◽  
Primary Outcome ◽  
Pediatric Patients ◽  
Case Series ◽  
Opioid Withdrawal ◽  
Limited Data ◽  
Serious Adverse Events ◽  
Patient Response ◽  
Hospital Patients

Abstract Objectives Methylnaltrexone is U.S. Food and Drug Administration (FDA) approved as a subcutaneous injection for adults with opioid-induced constipation (OIC). Case series have described the use of methylnaltrexone for OIC in the pediatric oncology population. There are limited data describing its intravenous use in critically ill pediatric patients. Methods We conducted a retrospective observational study at St. Louis Children's Hospital. Patients less than 18 years old who received at least one dose of intravenous methylnaltrexone while admitted to an intensive care unit between January 2016 and August 2019 were included. The primary outcome was documented laxation within 24 hours of methylnaltrexone administration. Results Sixteen patients received a total of 34 doses of intravenous methylnaltrexone. Patients received a median of 1.69 (interquartile range [IQR], 0.9–4.86) morphine milligram equivalents per kilogram per 24 hours, over a median of 14 days (IQR, 11–30), before methylnaltrexone administration. The median dose of methylnaltrexone was 0.15 mg/kg (IQR, 0.15–0.16). Ten patients (63%) responded to the first dose of methylnaltrexone, and 14 patients (88%) responded to at least one dose. Overall, 26 doses (76%) led to patient response. Four patients (25%) experienced adverse events (emesis, abdominal pain) after methylnaltrexone administration. No signs or symptoms of opioid withdrawal were documented. Conclusions Intravenous methylnaltrexone appears to be safe and effective in treating OIC in critically ill pediatric patients. No serious adverse events or signs of opioid withdrawal were observed after single and repeat dosing. Patients responded to methylnaltrexone with varying opioid dosing and durations prior to administration.

scholarly journals Efficacy and harms of remdesivir for the treatment of COVID-19: a systematic review and meta-analysis

2020 ◽  
Author(s):  
Alejandro Piscoya ◽  
Luis Fernando Ng-Sueng ◽  
Angela Parra del Riego ◽  
Renato Cerna-Viacava ◽  
Vinay Pasupuleti ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Clinical Improvement ◽  
Meta Analysis ◽  
Case Series ◽  
Length Of Hospital Stay ◽  
Invasive Ventilation ◽  
Serious Adverse Events ◽  
All Cause Mortality ◽  
Meta Analyses

AbstractBackgroundWe evaluated the efficacy and safety of remdesivir for the treatment of COVID-19.MethodsSystematic review in five engines, pre-print webpages and RCT registries until May 22, 2020 for randomized controlled trials (RCTs) and observational studies evaluating remdesivir on confirmed, COVID-19 adults with pneumonia and/or respiratory insufficiency. Primary outcomes were all-cause mortality, clinical improvement or recovery, need for invasive ventilation, and serious adverse events (SAE). Secondary outcomes included length of hospital stay, progression of pneumonia, and adverse events (AE). Inverse variance random effects meta-analyses were performed.ResultsTwo placebo-controlled RCTs (n=1300) and two case series (n=88) were included. All studies used remdesivir 200mg IV the first day and 100mg IV for 9 more days, and followed up until 28 days. Wang et al. RCT was stopped early due to AEs; ACTT-1 was preliminary reported at 15-day follow up. Time to clinical improvement was not decreased in Wang et al. RCT, but median time to recovery was decreased by 4 days in ACTT-1. Remdesivir did not decrease all-cause mortality (RR 0.71, 95%CI 0.39 to 1.28) and need for invasive ventilation at 14 days (RR 0.57, 95%CI 0.23 to 1.42), but had fewer SAEs (RR 0.77, 95%CI 0.63 to 0.94). AEs were similar between remdesivir and placebo arms. Risk of bias ranged from some concerns to high risk in RCTs.InterpretationThere is paucity of adequately powered and fully reported RCTs evaluating effects of remdesivir in adult, hospitalized COVID-19 patients. Remdesivir should not be recommended for the treatment of severe COVID-19.

scholarly journals Coccyx Fractures Treated with Intranasal Calcitonin

2014 ◽  
Vol 2;17 (2;3) ◽  
pp. E229-E333
Author(s):  
Patrick M. Foye
Keyword(s):  
Vertebral Fracture ◽  
Literature Review ◽  
Adverse Events ◽  
Acute Pain ◽  
Randomized Control Trial ◽  
Case Series ◽  
Control Group ◽  
Pain Center ◽  
Randomized Control ◽  
Design Case

Background: Treating pain associated with acute coccyx fractures can be challenging. Intranasal calcitonin has been used to treat acute pain after vertebral fracture, and may even accelerate fracture healing. However, intranasal calcitonin has never previously been published as part of the treatment of acute coccyx fractures. Objective: To examine a series of cases in which intranasal calcitonin was used to treat coccydynia related to coccyx fractures. Study Design: Case series and literature review. Setting: Outpatient university-based coccyx pain center. Results: After use of intranasal calcitonin, pain levels decreased, adverse events were minimal, and the medication was generally well tolerated. Limitations: As this is not a randomized control trial, the patients treated with intranasal calcitonin were not compared to a control group. Additionally, the sample size of 8 patients is relatively small. Conclusions: We propose that clinicians consider use of intranasal calcitonin for the treatment of pain due to acute coccyx fractures. Key words: Coccyx, fractures, calcitonin, pain

scholarly journals Patient Safety during ECMO Transportation: Single Center Experience and Literature Review

2021 ◽  
Vol 2021 ◽  
pp. 1-16
Author(s):  
Mateusz Puslecki ◽  
Konrad Baumgart ◽  
Marcin Ligowski ◽  
Marek Dabrowski ◽  
Sebastian Stefaniak ◽  
...  
Keyword(s):  
Systematic Review ◽  
Literature Review ◽  
Adverse Events ◽  
Rescue Therapy ◽  
High Volume ◽  
Transportation Safety ◽  
Serious Adverse Events ◽  
Mortality And Morbidity ◽  
Single Center Experience ◽  
Emergency Transport

Background. Extracorporeal membrane oxygenation (ECMO) has been proven to support in lifesaving rescue therapy. The best outcomes can be achieved in high-volume ECMO centers with dedicated emergency transport teams. Aim. The aim of this study was to analyze the safety of ECMO support during medical transfer on the basis of our experience developed on innovation cooperation and review of literature. Methods. A retrospective analysis of our experience of all ECMO-supported patients transferred from regional hospital of the referential ECMO center between 2015 and 2020 was carried out. Special attention was paid to transportation-related mortality and morbidity. Moreover, a systematic review of the Medline, Embase, Cochrane, and Google Scholar databases was performed. It included the original papers published before the end of 2019. Results. Twelve (5 women and 7 men) critically ill ECMO-supported patients with the median age of 33 years (2–63 years) were transferred to our ECMO center. In 92% (n = 11) of the cases venovenous and in 1 case, venoarterial supports were applied. The median transfer length was 45 km (5–200). There was no mortality during transfer and no serious adverse events occurred. Of note, the first ECMO-supported transfer had been proceeded by high-fidelity simulations. For our systematic review, 68 articles were found and 22 of them satisfied the search criteria. A total number of 2647 transfers were reported, mainly primary (90%) and as ground transportations (91.6%). A rate of adverse events ranged from 1% through 20% but notably only major complications were mentioned. The 4 deaths occurred during transport (mortality 0.15%). Conclusions. Our experiences and literature review showed that transportation for ECMO patients done by experienced staff was associated with low mortality rate but life-threatening adverse events might occur. Translational simulation is an excellent probing technique to improve transportation safety.

scholarly journals QOLP-23. PHASE II RANDOMISED PLACEBO-CONTROLLED DOUBLE-BLIND STUDY OF ACETAZOLAMIDE VERSUS PLACEBO FOR CEREBRAL OEDEMA IN RECURRENT AND/OR PROGRESSIVE HIGH-GRADE GLIOMA REQUIRING TREATMENT WITH DEXAMETHASONE

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii179-ii180
Author(s):  
Meera Agar ◽  
Anna Nowak ◽  
Elizabeth Hovey ◽  
Elizabeth Barnes ◽  
John Simes ◽  
...  
Keyword(s):  
Adverse Events ◽  
Dose Reduction ◽  
Primary Endpoint ◽  
Performance Status ◽  
Case Series ◽  
High Grade Glioma ◽  
Double Blind Study ◽  
High Grade ◽  
Serious Adverse Events ◽  
Double Blind

Abstract INTRODUCTION Symptoms of raised intracranial pressure (ICP) in recurrent or progressive high-grade glioma (HGG) generally require corticosteroid treatment, often causing toxicity with variable effects on reversing ICP symptoms. Acetazolamide reduces ICP in other clinical settings including case series in glioma. AIM To explore whether addition of oral acetazolamide enables safe dexamethasone dose reduction in management of raised ICP in recurrent and/or progressive HGG. METHODS Participants had recurrent, progressive and/or persistent residual HGG requiring recommencement of dexamethasone, dose increase or dexamethasone dependency; prior/current bevacizumab was an exclusion. Eligible participants were randomised 1:1 to acetazolamide 250mg twice daily or placebo for 8 weeks. Standardised protocols were used for dexamethasone dose changes in both arms, with planned dose decrease from day 5 once ICP symptoms were stable. The primary endpoint was a composite of dexamethasone dose reduction and stability of performance status. Secondary endpoints included toxicity and feasibility (accrual and compliance). RESULTS Thirty participants of a planned sample of 84 were enrolled (mean age 58 y (32-89)) from 7 Australian sites. The mean baseline dexamethasone dose was 6.2mg (4-16mg). Mean duration on treatment was 38 days (4-57) in placebo group and 31 days (3-60) in acetazolamide group, with 9 participants (30%) completing all study treatment (6 placebo, 3 acetazolamide). Study withdrawal was due to adverse events (n=6 (1 placebo, 5 acetazolamide)) and disease progression (n=6 (3 per arm)). Four participants (13%) (2 per arm) were stable responders meeting the primary endpoint criteria (≥50% corticosteroid dose reduction from baseline by 28 days maintained for 7 days, and no deterioration in performance status). Ten participants experienced a total of 13 serious adverse events (acetazolamide arm: 5 participants (33%), 6 events, 2 related). DISCUSSION The addition of acetazolamide did not facilitate dexamethasone reduction. The study closed early due to poor accrual and increasing availability of bevacizumab.

scholarly journals Compassionate use of recombinant human IL-7-hyFc as a salvage treatment for restoring lymphopenia in patients with recurrent glioblastoma

2022 ◽  
Author(s):  
Stephen Ahn ◽  
Jae-Sung Park ◽  
Heewon Kim ◽  
Minkyu Heo ◽  
Young Chul Sung ◽  
...  
Keyword(s):  
Adverse Events ◽  
Lymphocyte Count ◽  
Randomized Clinical Trials ◽  
Case Series ◽  
Recurrent Glioblastoma ◽  
Total Lymphocyte Count ◽  
Compassionate Use ◽  
Serious Adverse Events ◽  
Total Lymphocyte ◽  
Recurrent Gbm

Purpose Lymphopenia is frequently observed and is associated with poor prognosis in glioblastoma (GBM) patients. Restoring lymphopenia in cancer patients has been suggested as a novel immunotherapeutic strategy. As interleukin-7 (IL-7) is necessary for proliferation of lymphocytes and to amplify the total lymphocyte count (TLC), IL-7 therapy has been tried for various cancers, although the results are inconclusive. Here, we describe the clinical results of recurrent GBM treated with long-acting engineered version of recombinant human IL-7 (rhIL-7-hyFc). Methods This prospective case series based on compassionate use was approved by the Ministry of Food and Drug Safety in South Korea. Patients with recurrent GBM were enrolled to Seoul St. Mary's Hospital. Primary outcomes were the safety profile and elevated total lymphocyte count (TLC). Secondary outcomes were overall survival (OS) and progressionbfree survival (PFS). The duration of median follow up was 372.6 days (range 98-864 days). Results Among 18 patients enrolled, 10 received rhIL-7-hyFc with temozolomide, 5 received rhIL-7-hyFc with bevacizumab, 1 received rhIL-7-hyFc with PCV chemotherapy, and 2 received rhIL-7-hyFc alone. The mean TLC of enrolled patients after the first treatment with rhIL-7-hyFc was significantly increased from 1,131 cells/mm^3 (range 330-2,989) at baseline to 4,356 cells/mm^3 (range 661-22,661). Similar increase was observed in 16 of 18 patients (88.8%), only after the first treatment of rhIL-7-hyFc. TLCs of these patients were maintained higher while rhIL-7-hyFc was repeatedly administered. Most common adverse events were injection sites reactions (64.7%) including urticaria and itching sensation, however, there were no serious adverse events more than grade III. Median OS and PFS were 378 days (range 107-864 days) and 231 days (55-726 days), respectively. Conclusion Our study first reports that IL-7 immunotherapy can restore lymphopenia and maintain TLC with various salvageable chemotherapies in recurrent GBM patients without serious adverse toxicities. This outcome warrants further larger and randomized clinical trials to validate the clinical benefits of rhIL-7-hyFc for GBM patients.

scholarly journals Efficacy and Tolerability of Lacosamide in Lennox–Gastaut Syndrome: A Systematic Review and Meta-analysis

2022 ◽  
Author(s):  
Prateek Kumar Panda ◽  
Indar Kumar Sharawat ◽  
Lesa Dawman ◽  
Pragnya Panda ◽  
Ananthanarayanan Kasinathan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Seizure Frequency ◽  
Retrospective Studies ◽  
Case Reports ◽  
Random Effect ◽  
Random Effect Model ◽  
Case Series ◽  
Eligibility Criteria ◽  
Serious Adverse Events

Abstract Purpose Lennox–Gastaut syndrome (LGS) is one of the most difficult to treat childhood-onset epileptic encephalopathies. There is growing evidence that lacosamide is safe and efficacious in patients and adults with refractory epilepsy. However, the evidence regarding the efficacy of lacosamide in LGS is controversial so far. We aimed to evaluate the efficacy and tolerability of lacosamide in patients with LGS. Methods We conducted a systematic review on MEDLINE, EMBASE, COCHRANE CENTRAL, Google Scholar, and Web of Science, collating all available literature till July 31, 2020. The qualitative review included case reports, case series, and both controlled/uncontrolled trials as well as retrospective studies, but for determining pooled estimates, we only included studies with a sample size of 5 or more. The primary outcome was the efficacy of lacosamide in patients with LGS. Clinical variables related to efficacy and adverse events attributed to lacosamide were extracted from each publication. The pooled estimate of variables related to these parameters was performed using a random-effect model. Results Of the 68 items identified by the search, 14 were reviewed as full-text. Eleven articles including two prospective and six retrospective studies fulfilled eligibility criteria and described outcomes in 81 patients (42 adults, 39 children, 60% male, range—1.4–61 years). On average, 35.2%, 27.9%, 7.3%, and 29.4% patients had > 50% reduction, < 50% reduction, no change, and worsening of seizure frequency, respectively. Although 36% of patients had adverse events like somnolence, behavioral abnormalities including irritability, aggressiveness, nausea, tremor, memory problems, dizziness, gastrointestinal discomfort, vomiting, and weight loss, no serious adverse events were noted. Conclusion The evidence available in the current literature is not sufficient to support or refute the use of lacosamide in patients with LGS. Although it is one of the possible therapeutic options worth exploring in patients with LGS, caution is still necessary, as there are reports of worsening of seizure frequency in some patients.

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