scholarly journals Profile of adverse events in toxoplasmosis drug therapy: a review

2021 ◽  
Vol 10 (13) ◽  
pp. e505101321339
Author(s):  
Karlla Mayara Nunes de Sousa ◽  
Amanda Carla Corrêa Viana ◽  
Silvana de Fátima Ferreira da Silva Caires ◽  
Raquel Pedrosa Bezerra ◽  
Edmilson Mariano de Sousa Júnior ◽  
...  
Keyword(s):  
Drug Therapy ◽  
Adverse Events ◽  
Adverse Reactions ◽  
Case Reports ◽  
Congenital Toxoplasmosis ◽  
Inclusion Criteria ◽  
Time Restrictions ◽  
Bibliographic Search ◽  
Threat To Life ◽  
Hematological Alterations

This study aims to analyze the profile of adverse events (AEs) of drugs for the treatment of Toxoplasmosis. This is a review carried out through a bibliographic search in the electronic databases PubMed, SciELO, Cochrane Digital Library and LILACS. The keywords “Toxoplasmosis” AND “Drug Therapy” AND “Drug-Related Side Effects and Adverse Reactions” were used. The selection was performed by two independent reviewers and the articles were included considering the presence of retrospective studies and case reports published in the literature in Portuguese and English and without time restrictions. In total, 40 articles were found, of which 14 met the inclusion criteria. Cases of cerebral, ocular, gestational and congenital Toxoplasmosis were identified. Among these, we observed a total of 85 patients with reports of AEs due to the use of Pyrimethamine, Sulfadiazine, Spiramycin, Clindamycin, Atovaquone, Trimethoprim and Sulfamethoxazole and Sulfadoxine. Clinical reactions were in the form of skin rash (57.1%), hematological alterations (28.5%), Lyell syndromes (7.1%), Stevens-Johnson (21.4%) and DRESS (21 .4%). The prevalence of AEs related to hematological alterations was seen mainly in treatments based on Pyrimethamine + Sulfadiazine, Trimethoprim and Sulfamethoxazole; on the other hand, those associated with severe syndromes are often related to the use of Pyrimethamine + Sulfadiazine. It is important to establish a standard protocol for drug therapy for Toxoplasmosis, which does not yet exist. In addition, the need to monitor patients after drug administration is highlighted, given the possibility of the occurrence of adverse events that can represent a threat to life.

scholarly journals Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia

2021 ◽  
Author(s):  
Maciej Banach ◽  
Niki Katsiki ◽  
Gustavs Latkovskis ◽  
Manfredi Rizzo ◽  
Daniel Pella ◽  
...  
Keyword(s):  
Adverse Events ◽  
Adverse Reactions ◽  
Case Reports ◽  
Food Supplement ◽  
Product Line ◽  
Food Supplements ◽  
Red Yeast Rice ◽  
Red Yeast ◽  
Consumer Safety ◽  
Suspected Adverse Reactions

IntroductionIn the absence of a European standardized postmarketing food supplement surveillance system (nutrivigilance), some member states and companies have developed their own approaches to monitoring potential adverse reactions to secure a high level of product safety. This paper describes the use of a nutrivigilance system in monitoring the incidence of spontaneously reported suspected adverse reactions associated with food supplements containing red yeast rice (RYR).Material and methodsWe report the data from a widely used product marketed under the trademark Armolipid/Armolipid Plus. Postmarketing information was collected in a voluntary nutrivigilance system established by the manufacturing company (Meda Pharma SpA, a Viatris Company, Monza, Italy). From 1st October 2004 to 31st December 2019, this system captured cases of suspected adverse reactions spontaneously reported by consumers, healthcare professionals, health authorities, regardless of causality.ResultsThe total number of case reports received mentioning the RYR food supplement product line was 542, in which 855 adverse events (AEs) were reported. The total reporting rate of AEs was estimated to be 0.037% of 2,287,449 exposed consumers. Of the 542 cases, 21 (0.0009% of exposed consumers) included suspected serious adverse events (SAEs). After careful investigation, 6 cases (0.0003% of consumers exposed) and 6 AEs were assessed by the manufacturer as serious and potentially related to exposure to the above-mentioned RYR-based nutraceutical.ConclusionsThis nutrivigilance-derived data analysis clearly demonstrates a low prevalence of suspected adverse events associated with the red yeast rice product line. Consumer safety of food supplements could be generally improved by raising awareness of the importance of following the indications and warnings detailed in a food supplement’s labeling.

scholarly journals Safety of Moxibustion: A Systematic Review of Case Reports

2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Ji Xu ◽  
Hongyong Deng ◽  
Xueyong Shen
Keyword(s):  
Systematic Review ◽  
Basal Cell Carcinoma ◽  
Adverse Events ◽  
Medical Treatment ◽  
Cell Carcinoma ◽  
Premature Birth ◽  
Adverse Reactions ◽  
Case Reports ◽  
Fetal Distress ◽  
The World

Moxibustion is a traditional medical treatment originating in China. It involves using the heat of burning moxa to stimulate acupoints. It is considered safe and effective and is widely used throughout the world. The increasing use of moxibustion has drawn attention to the procedure’s adverse events (AEs). This review covers a total of 64 cases of AEs associated with moxibustion in 24 articles, reported in six countries. Some evidence of the risks of moxibustion has been found in these cases. AEs include allergies, burns, infection, coughing, nausea, vomiting, fetal distress, premature birth, basal cell carcinoma (BCC), ectropion, hyperpigmentation, and even death. The position, duration, distance between moxa and skin, proficiency of the practitioners, conditions of the patients, presence of smoke, and even the environment of treatment can affect the safety of moxibustion. Improving practitioner skill and regulating operations may reduce the incidence of adverse reactions and improve the security of moxibustion.

scholarly journals Severe adverse events following benzathine penicillin G injection for rheumatic heart disease prophylaxis: cardiac compromise more likely than anaphylaxis

Heart Asia ◽  
2019 ◽  
Vol 11 (2) ◽  
pp. e011191 ◽  
Author(s):  
Shannon Marantelli ◽  
Robert Hand ◽  
Jonathan Carapetis ◽  
Andrea Beaton ◽  
Rosemary Wyber
Keyword(s):  
Heart Disease ◽  
Adverse Events ◽  
Rheumatic Heart Disease ◽  
Adverse Reactions ◽  
Case Reports ◽  
Penicillin G ◽  
Alternative Mechanism ◽  
Benzathine Penicillin ◽  
Benzathine Penicillin G ◽  
Rheumatic Heart

ObjectiveSecondary prophylaxis through long-term antibiotic administration is essential to prevent the progression of acute rheumatic fever to rheumatic heart disease (RHD). Benzathine penicillin G (BPG) has been shown to be the most efficacious antibiotic for this purpose; however, adverse events associated with BPG administration have been anecdotally reported. This study therefore aimed to collate case reports of adverse events associated with BPG administration for RHD prophylaxis.Study designA literature review was used to explore reported adverse reactions to BPG and inform development of a case report questionnaire. This questionnaire was circulated through professional networks to solicit retrospective reports of adverse events from treating physicians. Returned surveys were tabulated and thematically analysed. Reactions were assessed using the Brighton Collaboration case definition to identity potential anaphylaxis.ResultsWe obtained 10 case reports from various locations, with patients ranging in age from early-teens to adults. All patients had clinical or echocardiogram-obtained evidence of valvular disease. The majority of patients (80%) had received BPG prior to the event with no previous adverse reaction. In eight cases, the reaction was fatal; in one case resuscitation was successful and in one case treatment was not required. Only three cases met Level 1 Brighton criteria consistent with anaphylaxis.ConclusionThese results indicate that anaphylaxis is not a major cause of adverse reactions to BPG. An alternative mechanism for sudden death following BPG administration in people with severe RHD is proposed.

scholarly journals Safety of Acupuncture Practice in Japan: Patient Reactions, Therapist Negligence and Error Reduction Strategies

2008 ◽  
Vol 5 (4) ◽  
pp. 391-398 ◽  
Author(s):  
Hitoshi Yamashita ◽  
Hiroshi Tsukayama
Keyword(s):  
Adverse Events ◽  
Clinical Training ◽  
Adverse Reactions ◽  
Case Reports ◽  
Feedback System ◽  
Minor Bleeding ◽  
Serious Adverse Events ◽  
Continued Education ◽  
Reduction Strategies ◽  
Almost All

Evidence-based approach on the safety of acupuncture had been lagging behind both in the West and the East, but reliable data based on some prospective surveys were published after the late 1990s. In the present article, we, focusing on ‘Japanese acupuncture’, review relevant case reports and prospective surveys on adverse events in Japan, assess the safety of acupuncture practice in this country, and suggest a strategy for reducing the therapists’ error. Based on the prospective surveys, it seems reasonable to suppose that serious adverse events are rare in standard practice by adequately trained acupuncturists, regardless of countries or modes of practice. Almost all of adverse reactions commonly seen in acupuncture practice—such as fatigue, drowsiness, aggravation, minor bleeding, pain on insertion and subcutaneous hemorrhage—are mild and transient, although we should be cautious of secondary injury following drowsiness and needle fainting. After demonstrating that acupuncture is inherently safe, we have been focusing on how to reduce the risk of negligence in Japan, as well as educating acupuncturists more about safe depth of insertion and infection control. Incident reporting and feedback system is a useful strategy for reducing therapist errors such as forgotten needles. For the benefit of acupuncture patients in Japan, it is important to establish mandatory postgraduate clinical training and continued education system.

Terson sign:

2020 ◽  
Vol 2 (1) ◽  
pp. 38-43
Author(s):  
Luiz Severo Bem Junior ◽  
Gustavo De Souza Andrade ◽  
Joao Ribeiro Memória Júnior ◽  
Hildo Rocha Cirne de Azevedo Filho
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Early Recognition ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Case Reports ◽  
Clinical Status ◽  
Vitreous Hemorrhage ◽  
Anterior Communicating Artery ◽  
Inclusion Criteria ◽  
Relationship Of ◽  
The Relationship

Terson's sign (TS) is classically defined as vitreous hemorrhage associated with subarachnoid hemorrhage of aneurysmal origin, being an important predictor of severity, indicating greater morbidity and mortality when compared to patients without the sign. The objective of this study is to review the relationship of Terson syndrome/Terson sign with the prognosis of aneurysmal subarachnoid hemorrhage. A search for original articles, research and case reports was performed on the PubMed, Scielo, Cochrane and ScienceDirect platform, with the following descriptors: Terson sign and subarachnoid hemorrhage. Retrospective, prospective articles and case reports published in the last 5 years and which were in accordance with the established objective and inclusion criteria were selected. Ten (10) articles were selected, in which the available results show an unfavorable prognostic relationship of TS and subarachnoid hemorrhage, because these patients had a worse clinical status assessed on the Glasgow scales ≤ 8, Hunt & Hess > III, Fisher > 3, in addition to intracranial hypertension and location of the aneurysm in the anterior communicating artery complex. The early recognition of this condition described by Albert Terson in 1900 brought an important contribution to neurosurgery, being recognized until nowadays.

Adverse Effects of Natural Products: A Brief Pre-Systematic Review

2020 ◽  
Vol 01 ◽  
Author(s):  
Carla Pires ◽  
Ana Fernandes
Keyword(s):  
Systematic Review ◽  
Adverse Event ◽  
Natural Products ◽  
Adverse Events ◽  
In Vitro Study ◽  
Google Scholar ◽  
Inclusion Criteria ◽  
Exclusion Criteria ◽  
Meta Analyses

Background: Natural products are commonly used for treating health problems. These products may be associated with adverse events, which are defined as "noxious and unintended response to a medicinal product" by the European Medicine Agency. Objectives: To identify studies describing at least one adverse event (or with potential to promote an adverse event) related to the use of natural products, as well as to describe the involved product(s) and adverse event(s). Methods: A pre-systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria. Keywords: "natural product(s)" and ["adverse drug reaction(s)" or "adverse effect(s)"]. Screened databases: PubMed, SciELO, DOAJ and Google Scholar. Inclusion criteria: papers describing at least one adverse event associated with the use of natural products and published between 2017 and 2019. Exclusion criteria: Repeated studies, reviews and papers written in other languages than English, Portuguese, French or Spanish. Results: 104 studies were identified (20 PubMed; 0 SciELO; 2 DOAJ; 82 Google Scholar), but only 10 were selected (4 PubMed and 6 Google Scholar): 1 in-vitro study; 2 non-clinical studies, 1 study reporting in-vitro and clinical data and 5 studies were cases reports. Globally, 997 reports of adverse drug reactions with natural products were identified, mainly non-severe cases. Conclusion: Since a limited number of studies was found, we conclude that adverse events due to natural products may be underreported, or natural products may have a good safety profile. This review contributes for assuring the safety of natural products consumers, by evaluating the knowledge/information on the potential adverse events and interactions of these products.

scholarly journals The Safety and Effect of Local Botulinumtoxin A Injections for Long-Term Management of Chronic Pain in Post-Herpetic Neuralgia: Literature Review and Cases Report Treated with Incobotulinumtoxin A

2021 ◽  
Vol 11 (8) ◽  
pp. 758
Author(s):  
Songjin Ri ◽  
Anatol Kivi ◽  
Jörg Wissel
Keyword(s):  
Chronic Pain ◽  
Neuropathic Pain ◽  
Adverse Events ◽  
Case Reports ◽  
Pain Reduction ◽  
Post Herpetic Neuralgia ◽  
Botulinumtoxin A ◽  
Incobotulinumtoxin A ◽  
Term Management

There are few reports on the safety and effectiveness of long-term botulinumtoxin A (BoNT A) therapy in severe chronic pain of post-herpetic neuralgia (PHN). The literature was searched with the term “neuropathic pain” and “botulinum” on PubMed (up to 29 February 2020). Pain was assessed with the Visual Analogue Scale (VAS) before and after BoNT A therapy. A total of 10 clinical trials and six case reports including 251 patients with PHN were presented. They showed that BoNT A therapy had significant pain reduction (up to 30–50%) and improvement in quality of life. The effect duration seems to be correlated with BoNT A doses injected per injection site. Intervals between BoNT A injections were 10–14 weeks. No adverse events were reported in cases and clinical studies, even in the two pregnant women, whose babies were healthy. The repeated (≥6 times) intra/subcutaneous injections of incobotulinumtoxin A (Xeomin®, Merz Pharmaceuticals, Germany) over the two years of our three cases showed marked pain reduction and no adverse events. Adjunctive local BoNT A injection is a promising option for severe PHN, as a safe and effective therapy in long-term management for chronic neuropathic pain. Its effect size and -duration seem to be depended on the dose of BoNT A injected per each point.

scholarly journals Zolpidem for Insomnia: A Double-Edged Sword. A Systematic Literature Review on Zolpidem-Induced Complex Sleep Behaviors

2021 ◽  
pp. 025371762199237
Author(s):  
Niti Mittal ◽  
Rakesh Mittal ◽  
M. C. Gupta
Keyword(s):  
Adverse Reactions ◽  
Case Reports ◽  
Case Series ◽  
Eligibility Criteria ◽  
Study Objective ◽  
Spontaneous Reports ◽  
Cochrane Database ◽  
Sleep Behaviors ◽  
Therapeutic Doses ◽  
Favorable Side Effect Profile

Background: Being a nonbenzodiazepine, zolpidem is believed to have a favorable side-effect profile and is widely prescribed for insomnia. However, in the past few years, numerous neuropsychiatric adverse reactions, particularly complex sleep behaviors (CSBs), have been reported with zolpidem. Objective: To conduct a systematic review of zolpidem-associated CSBs. Data Sources: An electronic search was conducted using MEDLINE, Embase, PubMed, and Cochrane database of systematic reviews to extract relevant articles till July 2020. Study Eligibility Criteria: Any type of literature article (case report, case series, and observational or interventional study) reporting CSBs associated with zolpidem. Results: In this review, we present aggregate summarized data from 148 patients presenting with zolpidem-induced CSBs (79 patients from 23 case reports and 5 case series; 69 patients out of 1454 taking zolpidem [4.7%] from three observational clinical studies). Various types of CSBs associated with zolpidem were reported, most common being sleepwalking/somnambulism and sleep-related eating disorder. On causality assessment, around 88% of cases were found to have a probable association with zolpidem. Limitations: Extraction of data from observational studies and spontaneous reports, due to nonavailability of any randomized controlled trials relevant to the study objective. Conclusion and Implication of Key Findings: Zolpidem-induced CSBs, although not very common, may develop when the drug is used at therapeutic doses for insomnia. Doctors need to be alert to monitor such adverse effects of zolpidem and exercise caution while prescribing it.

Treatment of attention deficit/hyperactivity disorder in children with CHD

2021 ◽  
pp. 1-4
Author(s):  
Alyson R. Pierick ◽  
Melodie Lynn ◽  
Courtney M. McCracken ◽  
Matthew E. Oster ◽  
Glen J. Iannucci
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
General Population ◽  
Adverse Events ◽  
Supraventricular Tachycardia ◽  
Medical Therapy ◽  
Attention Deficit ◽  
Case Reports ◽  
Single Centre ◽  
Hyperactivity Disorder ◽  
Increased Risk

Abstract Introduction: The prevalence of attention deficit/hyperactivity disorder in the general population is common and is now diagnosed in 4%–12% of children. Children with CHD have been shown to be at increased risk for attention deficit/hyperactivity disorder. Case reports have led to concern regarding the use of attention deficit/hyperactivity disorder medications in children with underlying CHD. We hypothesised that medical therapy for patients with CHD and attention deficit/hyperactivity disorder is safe. Methods: A single-centre, retrospective chart review was performed evaluating for adverse events in patients aged 4–21 years with CHD who received attention deficit/hyperactivity disorder therapy over a 5-year span. Inclusion criteria were a diagnosis of CHD and concomitant medical therapy with amphetamines, methylphenidate, or atomoxetine. Patients with trivial or spontaneously resolved CHD were excluded from analysis. Results: In 831 patients with CHD who received stimulants with a mean age of 12.9 years, there was only one adverse cardiovascular event identified. Using sensitivity analysis, our median follow-up time was 686 days and a prevalence rate of 0.21% of adverse events. This episode consisted of increased frequency of supraventricular tachycardia in a patient who had this condition prior to initiation of medical therapy; the condition improved with discontinuation of attention deficit/hyperactivity disorder therapy. Conclusion: The incidence of significant adverse cardiovascular events in our population was similar to the prevalence of supraventricular tachycardia in the general population. Our single-centre experience demonstrated no increased risk in adverse events related to medical therapy for children with attention deficit/hyperactivity disorder and underlying CHD. Further population-based studies are indicated to validate these findings.

scholarly journals Ocular adverse events associated with immune checkpoint inhibitors: a novel multidisciplinary management algorithm

2021 ◽  
Vol 13 ◽  
pp. 175883592199298
Author(s):  
Orthi Shahzad ◽  
Nicola Thompson ◽  
Gerry Clare ◽  
Sarah Welsh ◽  
Erika Damato ◽  
...  
Keyword(s):  
Adverse Events ◽  
Checkpoint Inhibitors ◽  
Case Reports ◽  
Case Series ◽  
Simple Algorithm ◽  
Cancer Therapeutics ◽  
Management Algorithm ◽  
Ocular Symptoms ◽  
Systemic Corticosteroids ◽  
Permanent Loss

Ocular immune-related adverse events (IrAEs) associated with use of checkpoint inhibitors (CPIs) in cancer therapeutics are relatively rare, occurring in approximately 1% of treated patients. Recognition and early intervention are essential because the degree of tissue damage may be disproportionate to the symptoms, and lack of appropriate treatment risks permanent loss of vision. International guidelines on managing ocular IrAEs provide limited advice only. Importantly, local interventions can be effective and may avoid the need for systemic corticosteroids, thereby permitting the continuation of CPIs. We present a single institution case series of eight affected patients managed by our multidisciplinary team. Consistent with previously published series and case reports, we identified anterior uveitis as the most common ocular IrAE associated with CPIs requiring intervention. Based on our experience, as well as published guidance, we generated a simple algorithm to assist clinicians efficiently manage patients developing ocular symptoms during treatment with CPIs. In addition, we make recommendations for optimising treatment of uveitis and address implications for ongoing CPI therapy.

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