scholarly journals How Safe Are Common Analgesics for the Treatment of Acute Pain for Children? A Systematic Review

2016 ◽  
Vol 2016 ◽  
pp. 1-15 ◽  
Author(s):  
Lisa Hartling ◽  
Samina Ali ◽  
Donna M. Dryden ◽  
Pritam Chordiya ◽  
David W. Johnson ◽  
...  
Keyword(s):  
Adverse Events ◽  
Dual Therapy ◽  
Pain Medication ◽  
Incidence Rates ◽  
Current Evidence ◽  
Random Effects Model ◽  
National Data ◽  
Oral Medications ◽  
Comprehensive Search ◽  
Inflammatory Drugs

Background. Fear of adverse events and occurrence of side effects are commonly cited by families and physicians as obstructive to appropriate use of pain medication in children. We examined evidence comparing the safety profiles of three groups of oral medications, acetaminophen, nonsteroidal anti-inflammatory drugs, and opioids, to manage acute nonsurgical pain in children (<18 years) treated in ambulatory settings.Methods. A comprehensive search was performed to July 2015, including review of national data registries. Two reviewers screened articles for inclusion, assessed methodological quality, and extracted data. Risks (incidence rates) were pooled using a random effects model.Results. Forty-four studies were included; 23 reported on adverse events. Based on limited current evidence, acetaminophen, ibuprofen, and opioids have similar nausea and vomiting profiles. Opioids have the greatest risk of central nervous system adverse events. Dual therapy with a nonopioid/opioid combination resulted in a lower risk of adverse events than opioids alone.Conclusions. Ibuprofen and acetaminophen have similar reported adverse effects and notably less adverse events than opioids. Dual therapy with a nonopioid/opioid combination confers a protective effect for adverse events over opioids alone. This research highlights challenges in assessing medication safety, including lack of more detailed information in registry data, and inconsistent reporting in trials.

scholarly journals Patterns in neurosurgical adverse events: endovascular neurosurgery

2012 ◽  
Vol 33 (5) ◽  
pp. E14 ◽  
Author(s):  
Judith M. Wong ◽  
John E. Ziewacz ◽  
Jaykar R. Panchmatia ◽  
Angela M. Bader ◽  
Aditya S. Pandey ◽  
...  
Keyword(s):  
Adverse Events ◽  
Management Strategies ◽  
Incidence Rates ◽  
Aneurysm Rupture ◽  
Current Evidence ◽  
Related Complication ◽  
Safety Interventions ◽  
Mode Of Detection ◽  
Risk Patients ◽  
Hospital Acquired

As part of a project to devise evidence-based safety interventions for specialty surgery, the authors sought to review current evidence in endovascular neurosurgery concerning the frequency of adverse events in practice, their patterns, and current methods of reducing the occurrence of these events. This review represents part of a series of papers written to consolidate information about these events and preventive measures as part of an ongoing effort to ascertain the utility of devising system-wide policies and safety tools to improve neurosurgical practice. Based on a review of the literature, thromboembolic events appeared to be the most common adverse events in endovascular neurosurgery, with a reported incidence ranging from 2% to 61% depending on aneurysm rupture status and mode of detection of the event. Intraprocedural and periprocedural prevention and rescue regimens are advocated to minimize this risk; however, evidence on the optimal use of anticoagulant and antithrombotic agents is limited. Furthermore, it is unknown what proportion of eligible patients receive any prophylactic treatment. Groin-site hematoma is the most common access-related complication. Data from the cardiac literature indicate an overall incidence of 9% to 32%, but data specific to neuroendovascular therapy are scant. Manual compression, compression adjuncts, and closure devices are used with varying rates of success, but no standardized protocols have been tested on a broad scale. Contrast-induced nephropathy is one of the more common causes of hospital-acquired renal insufficiency, with an incidence of 30% in high-risk patients after contrast administration. Evidence from medical fields supports the use of various preventive strategies. Intraprocedural vessel rupture is infrequent, with the reported incidence ranging from 1% to 9%, but it is potentially devastating. Improvements in device technology combined with proper endovascular technique play an important role in reducing this risk. Occasionally, anatomical or technical difficulties preclude treatment of the lesion of interest. Reports of such occurrences are scant, but existing series suggest an incidence of 4% to 6%. Management strategies for radiation-induced effects are also discussed. The incidence rates are unknown, but protective techniques have been demonstrated. Many of these complications have strategies that appear effective in reducing their risk of occurrence, but development and evaluation of systematic guidelines and protocols have been widely lacking. Furthermore, there has been little monitoring of levels of adherence to potentially effective practices. Protocols and monitoring programs to support integrated implementation may be broadly effective.

scholarly journals Adverse events of special interest in clinical trials of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and psoriasis with 37 066 patient-years of tofacitinib exposure

RMD Open ◽  
2021 ◽  
Vol 7 (2) ◽  
pp. e001595
Author(s):  
Gerd R Burmester ◽  
Peter Nash ◽  
Bruce E Sands ◽  
Kim Papp ◽  
Lori Stockert ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Ulcerative Colitis ◽  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Special Interest ◽  
Phase 1 ◽  
Incidence Rates ◽  
Study Data ◽  
System Organ Class

ObjectivesTo analyse adverse events (AEs) of special interest across tofacitinib clinical programmes in rheumatoid arthritis (RA), psoriatic arthritis (PsA), ulcerative colitis (UC) and psoriasis (PsO), and to determine whether the incidence rates (IRs; unique patients with events per 100 patient-years) of these events are consistent across diseases.MethodsThe analysis included data from patients exposed to ≥1 dose of tofacitinib in phase 1, 2, 3 or 3b/4 clinical trials and long-term extension (LTE) studies (38 trials) in RA (23 trials), PsA (3 trials), UC (5 trials) and PsO (7 trials). All studies were completed by or before July 2019, except for one ongoing UC LTE study (data cut-off May 2019). IRs were obtained for AEs of special interest.Results13 567 patients were included in the analysis (RA: n=7964; PsA: n=783; UC: n=1157; PsO: n=3663), representing 37 066 patient-years of exposure. Maximum duration of exposure was 10.5 years (RA). AEs within the ‘infections and infestations’ System Organ Class were the most common in all diseases. Among AEs of special interest, IRs were highest for herpes zoster (non-serious and serious; 3.6, 1.8, 3.5 and 2.4 for RA, PsA, UC and PsO, respectively) and serious infections (2.5, 1.2, 1.7 and 1.3 for RA, PsA, UC and PsO, respectively). Age-adjusted and sex-adjusted mortality ratios (weighted for country) were ≤0.2 across cohorts.ConclusionsThe tofacitinib safety profile in this analysis was generally consistent across diseases and with longer term follow-up compared with previous analyses.

scholarly journals Musculoskeletal Disorders, Pain Medication and In-Hospital Mortality among Patients with COVID-19 in South Korea: A Population-Based Cohort Study

2021 ◽  
Vol 18 (13) ◽  
pp. 6804
Author(s):  
Tak-Kyu Oh ◽  
In-Ae Song ◽  
Joon Lee ◽  
Woosik Eom ◽  
Young-Tae Jeon
Keyword(s):  
South Korea ◽  
Hospital Mortality ◽  
Musculoskeletal Disorders ◽  
Multivariate Logistic Regression Analysis ◽  
Population Based ◽  
Pain Medication ◽  
Multivariate Logistic Regression ◽  
Lower Back ◽  
Inflammatory Drugs ◽  
Strong Opioids

We aimed to investigate whether comorbid musculoskeletal disorders (MSD)s and pain medication use was associated with in-hospital mortality among patients with coronavirus disease 2019 (COVID-19). Adult patients (≥20 years old) with a positive COVID-19 diagnosis until 5 June 2020 were included in this study, based on the National Health Insurance COVID-19 database in South Korea. MSDs included osteoarthritis, neck pain, lower back pain, rheumatoid arthritis, and others, while pain medication included paracetamol, gabapentin, pregabalin, glucocorticoid, nonsteroidal anti-inflammatory drugs (NSAIDs), opioids (strong and weak opioids), and benzodiazepine. Primary endpoint was in-hospital mortality. A total of 7713 patients with COVID-19 were included, and in-hospital mortality was observed in 248 (3.2%) patients. In multivariate logistic regression analysis, no MSDs (p > 0.05) were significantly associated with in-hospital mortality. However, in-hospital mortality was 12.73 times higher in users of strong opioids (odds ratio: 12.73, 95% confidence interval: 2.44–16.64; p = 0.002), while use of paracetamol (p = 0.973), gabapentin or pregabalin (p = 0.424), glucocorticoid (p = 0.673), NSAIDs (p = 0.979), weak opioids (p = 0.876), and benzodiazepine (p = 0.324) was not associated with in-hospital mortality. In South Korea, underlying MSDs were not associated with increased in-hospital mortality among patients with COVID-19. However, use of strong opioids was significantly associated with increased in-hospital mortality among the patients.

Lenalidomide-induced arthritis: A case report and review of literature and pharmacovigilance databases

2021 ◽  
pp. 107815522110380
Author(s):  
Charlotte Icard ◽  
Pauline Mocquot ◽  
Jean-Claude Nogaro ◽  
Fabien Despas ◽  
Martin Gauthier
Keyword(s):  
Case Report ◽  
Adverse Events ◽  
Inflammatory Markers ◽  
Maintenance Treatment ◽  
Cell Lymphoma ◽  
Mechanisms Of Action ◽  
Review Of Literature ◽  
International Database ◽  
Mantle Cell ◽  
Inflammatory Drugs

Introduction Lenalidomide is an immunomodulatory agent with multiple mechanisms of action, and treatment with lenalidomide is associated with adverse events such as thrombosis and abdominal pain; nonetheless, other rarer adverse events do exist, with few knowledge from physicians and pharmacists. For such adverse events, pharmacovigilance databases are of great interest. Case report A 71-year-old patient with no rheumatologic history, in complete remission of a mantle-cell lymphoma following rituximab, doxorubicin, vincristine, cyclophosphamide, and prednisone induction, received a maintenance treatment with rituximab and lenalidomide. After each course of lenalidomide and with no other new medication, the patient presented with fever and high inflammatory markers level, and a scapular-belt arthritis. Management and outcome The patient was managed with non-steroidal anti-inflammatory drugs and colchicine, with symptomatology and inflammation improvement. After discontinuation of lenalidomide, he had no arthritis relapse; it was then concluded that the patient had a lenalidomide-induced arthritis. We interrogated the national and international (VigiBase®) pharmacovigilance databases and found that arthritis in the context of lenalidomide exposure is a rare finding, with only three reported cases in France; 0.13% of adverse events reported with lenalidomide in the international database VigiBase® were arthritis. Discussion Our case then reports an uncommon finding, of which both pharmacists and physicians should be aware due to the wide and increasing use of lenalidomide.

Pulsed Ultrasounds Reduce Pain and Disability, Increasing Rib Fracture Healing, in a Randomized Controlled Trial

Pain Medicine ◽  
2018 ◽  
Vol 20 (10) ◽  
pp. 1980-1988
Author(s):  
Norberto Santana-Rodríguez ◽  
Bernardino Clavo ◽  
Pedro Llontop ◽  
María D Fiuza ◽  
Joaquín Calatayud-Gastardi ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Controlled Trial ◽  
Pain Medication ◽  
Control Group ◽  
Work Activity ◽  
Randomized Controlled ◽  
Medication Intake ◽  
Bone Callus

AbstractIntroductionRib fractures are an important health issue worldwide, with significant, pain, morbidity, and disability for which only symptomatic treatment exists.ObjectivesBased on our previous experimental model, the objective of the current study was to assess for the first time whether pulsed ultrasound (PUS) application could have beneficial effects on humans.MethodsProspective, double-blinded, randomized, controlled trial of 51 patients. Four were excluded, and 47 were randomized into the control group (N = 23) or PUS group (N = 24). The control group received a PUS procedure without emission, and the PUS group received 1 Mhz, 0.5 W/cm2 for 1 min/cm2. Pain level, bone callus healing rate, physical and work activity, pain medication intake, and adverse events were blindly evaluated at baseline and one, three, and six months.ResultsThere were no significant differences at baseline between groups. PUS treatment significantly decreased pain by month 1 (P = 0.004), month 3 (P = 0.005), and month 6 (P = 0.025), significantly accelerated callus healing by month 1 (P = 0.013) and month 3 (P < 0.001), accelerated return to physical activity by month 3 (P = 0.036) and work activity (P = 0.001) by month 1, and considerably reduced pain medication intake by month 1 (P = 0.057) and month 3 (P = 0.017). No related adverse events were found in the PUS group.ConclusionsThis study is the first evidence that PUS treatment is capable of improving rib fracture outcome, significantly accelerating bone callus healing, and decreasing pain, time off due to both physical activity and convalescence period, and pain medication intake. It is a safe, efficient, and low-cost therapy that may become a new treatment for patients with stable rib fractures.

scholarly journals Treatment of rheumatic immune-related adverse events due to cancer immunotherapy with immune checkpoint inhibitors—is it time for a paradigm shift?

2020 ◽  
Author(s):  
Katerina Chatzidionysiou ◽  
Matina Liapi ◽  
Georgios Tsakonas ◽  
Iva Gunnarsson ◽  
Anca Catrina
Keyword(s):  
Adverse Events ◽  
Cancer Immunotherapy ◽  
Potential Risk ◽  
Immune Checkpoint ◽  
Paradigm Shift ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Current Evidence ◽  
Inadequate Response ◽  
High Efficacy

Abstract Immunotherapy has revolutionized cancer treatment during the last years. Several monoclonal antibodies that are specific for regulatory checkpoint molecules, that is, immune checkpoint inhibitors (ICIs), have been approved and are currently in use for various types of cancer in different lines of treatment. Cancer immunotherapy aims for enhancing the immune response against cancer cells. Despite their high efficacy, ICIs are associated to a new spectrum of adverse events of autoimmune origin, often referred to as immune-related adverse events (irAEs), which limit the utility of these drugs. These irAEs are quite common and can affect almost every organ. The grade of toxicity varies from very mild to life-threatening. The pathophysiological mechanisms behind these events are not fully understood. In this review, we will summarize current evidence specifically regarding the rheumatic irAEs and we will focus on current and future treatment strategies. Treatment guidelines largely support the use of glucocorticoids as first-line therapy, when symptomatic therapy is not efficient, and for more persistent and/or moderate/severe degree of inflammation. Targeted therapies are higher up in the treatment pyramid, after inadequate response to glucocorticoids and conventional, broad immunosuppressive agents, and for severe forms of irAEs. However, preclinical data provide evidence that raise concerns regarding the potential risk of impaired antitumoral effect. This potential risk of glucocorticoids, together with the high efficacy and potential synergistic effect of newer, targeted immunomodulation, such as tumor necrosis factor and interleukin-6 blockade, could support a paradigm shift, where more targeted treatments are considered earlier in the treatment sequence.

scholarly journals Antimicrobial Activity of Non-steroidal Anti-inflammatory Drugs on Biofilm: Current Evidence and Potential for Drug Repurposing

2021 ◽  
Vol 12 ◽  
Author(s):  
Rodrigo Cuiabano Paes Leme ◽  
Raquel Bandeira da Silva
Keyword(s):  
Bacterial Species ◽  
Drug Repurposing ◽  
Current Evidence ◽  
Pharmacokinetic Studies ◽  
Bacterial Populations ◽  
Human Pharmacokinetic ◽  
Inflammatory Drugs ◽  
Anti Inflammatory

It has been demonstrated that some non-steroidal anti-inflammatory drugs (NSAIDs), like acetylsalicylic acid, diclofenac, and ibuprofen, have anti-biofilm activity in concentrations found in human pharmacokinetic studies, which could fuel an interest in repurposing these well tolerated drugs as adjunctive therapies for biofilm-related infections. Here we sought to review the currently available data on the anti-biofilm activity of NSAIDs and its relevance in a clinical context. We performed a systematic literature review to identify the most commonly tested NSAIDs drugs in the last 5 years, the bacterial species that have demonstrated to be responsive to their actions, and the emergence of resistance to these molecules. We found that most studies investigating NSAIDs’ activity against biofilms were in vitro, and frequently tested non-clinical bacterial isolates, which may not adequately represent the bacterial populations that cause clinically-relevant biofilm-related infections. Furthermore, studies concerning NSAIDs and antibiotic resistance are scarce, with divergent outcomes. Although the potential to use NSAIDs to control biofilm-related infections seems to be an exciting avenue, there is a paucity of studies that tested these drugs using appropriate in vivo models of biofilm infections or in controlled human clinical trials to support their repurposing as anti-biofilm agents.

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