scholarly journals False-Positive Results of Radionuclide Imaging in Lactating Breasts: a pharmacovigilance perspective

2020 ◽  
pp. 38-45
Author(s):  
Vojislav Kišić ◽  
Jennifer Parish
Keyword(s):  
Adverse Events ◽  
Medical Literature ◽  
Case Reports ◽  
Nuclear Imaging ◽  
False Positives ◽  
Safety And Efficacy ◽  
Literature Searches ◽  
Safety Specification ◽  
Medical Dictionary ◽  
Positive Results

Background: Misleading diagnostic results, including false-positives, potentially impact both the safety and efficacy profiles of radiopharmaceuticals used for diagnostic purposes. It is unclear, however, if false-positives occurring with radio-pharmaceuticals in lactating breasts are regularly reported as adverse events. Methods: Scientific medical literature (PubMed and Google Scholar) and the EudraVigilance database of suspected adverse drug reaction reports were searched for case reports of false-positives with radiopharmaceuticals appearing in lactating breasts. Medical Dictionary for Regulatory Activities (MedDRA) was reviewed for terms that could be used to capture reports of false-positives occurring in breast nuclear imaging accurately. Results: Literature searches showed that 40 case reports of false-positives have been observed with radiopharmaceuticals in lactating breasts but that these do not appear to be consistently reported to EudraVigilance as adverse events. MedDRA did not contain terms suitable for capturing false-positives in breasts with radiopharmaceuticals, but newly proposed terms were all approved. Conclusion: Increased reporting of false-positives as adverse events could help further clarify the safety specification of radiopharmaceuticals.

Insect Repellent (N,N-Diethyl-m-Toluamide) Cardiovascular Toxicity in an Adult

1993 ◽  
Vol 27 (3) ◽  
pp. 289-293 ◽  
Author(s):  
James R. Clem ◽  
David F. Havemann ◽  
Marsha A. Raebel
Keyword(s):  
Medical Literature ◽  
Case Reports ◽  
Data Extraction ◽  
Clinical Manifestations ◽  
Personal Contact ◽  
Cardiovascular Toxicity ◽  
Insect Repellents ◽  
Literature Searches ◽  
Study Selection ◽  
Animal Data

OBJECTIVE: To describe a case of N,N-diethyl- m-toluamide (DEET)-induced cardiovascular toxicity in an adult and reviews other cases that have been reported in the published literature. Human and animal data available on DEET pharmacokinetics are reviewed and factors that predispose an individual to DEET toxicity are identified. DATA SOURCES: Case report information was obtained through personal contact with the patient during hospitalization and by telephone, and also from the patient's medical records. Computerized literature searches were conducted with the following systems to obtain medical literature on DEET toxicity: TOXLINE, International Pharmaceutical Abstracts, and MEDLINE. Index Medicus was searched manually. STUDY SELECTION: All reported cases of DEET toxicity in children and adults were reviewed. DATA EXTRACTION: Case reports were evaluated for the quantity of the DEET exposure (topical or oral), the clinical manifestations of the exposure, and the outcome of the exposure. DATA SYNTHESIS: This case is similar in some aspects to those already in the literature; however, very few cases of DEET toxicity in adults have been reported. Cardiovascular toxicity in humans related to DEET application has not been previously reported in the published medical literature. DEET exposure (topical or oral) results in a highly variable clinical course. Whether the outcome is death or recovery without sequelae is difficult to predict. CONCLUSIONS: Adults, as well as children, are at risk for toxicity from insect repellents. The use of highly concentrated DEET-containing insect repellents should be avoided to reduce the risk of toxicity in both children and adults. The consequences of DEET toxicity are variable and unpredictable.

scholarly journals Multiple Doses of Icatibant used during Pregnancy

2017 ◽  
Vol 8 (3) ◽  
pp. ar.2017.8.0210 ◽  
Author(s):  
Lauren W. Kaminsky ◽  
Theodore Kelbel ◽  
Fay Ansary ◽  
Timothy Craig
Keyword(s):  
Adverse Events ◽  
Literature Search ◽  
Medical Literature ◽  
Case Reports ◽  
Treatment Options ◽  
Multiple Treatment ◽  
Multiple Doses ◽  
Healthy Infants

Background Hereditary angioedema (HAE) is a life-long disease that often manifests by puberty. Treatment of attacks is essential to improve quality of life and to decrease morbidity and mortality. During pregnancy, treatment is limited because multiple treatment options, including icatibant, are not approved for use during pregnancy. Objective We report the outcomes of three pregnancies during which icatibant was used by a patient with HAE with normal C1-inhibitor for treatment of attacks. We also reviewed the literature for reports of icatibant use during pregnancy for outcomes and adverse events. Methods We report on a patient who treated herself with icatibant during three separate pregnancies. Postpartum follow-up verified the health of the mother and children. We also performed a complete literature search of medical literature data bases on icatibant use during pregnancy. Results The patient in our report administered multiple doses of icatibant during three pregnancies. The child born from the first pregnancy and the child from the third pregnancy were born at term and without congenital anomalies. The child from the second pregnancy was 1-month preterm. All three children were developmentally normal. The literature search identified two case reports and one abstract of limited icatibant use without adverse events during pregnancy in patients with HAE. These pregnancies resulted in the births of healthy infants. Conclusion From a search of the literature, three cases of icatibant use during pregnancy resulted in healthy infants. In addition, we report that from icatibant use in three separate pregnancies, one infant was born prematurely, but there were no birth defects. From follow-up, the children continued meeting developmental milestones. This report adds to the acquisition of knowledge for drug adverse events during postmarketing surveillance for icatibant use during pregnancy.

scholarly journals Hiccups Associated with Steroid Injection: A Case Report

2021 ◽  
Vol 5 (6) ◽  
pp. CR1-CR3
Author(s):  
Payal Rastogi ◽  
Neya Kamra ◽  
Ommar Mohammad ◽  
Trishna Nagar
Keyword(s):  
Case Report ◽  
Adverse Events ◽  
Medical Literature ◽  
Steroid Injection ◽  
Case Reports ◽  
Epidural Steroid Injection ◽  
Epidural Steroid

Hiccups fall under rare adverse events that occur after an epidural steroid injection. A few studies in medical literature have reported on the physiological and pharmacological aspects of the same and some case reports have also been published. We hereby report a case of a 37-year-old woman who presented with hiccups after epidural steroid injection. She was successful treated with chlorpromazine and omeprazole.

Medical Literature Searches -How Many Bibliographic Databases are Needed for Sufficient Retrieval in Medical Topics?

1985 ◽  
Vol 24 (03) ◽  
pp. 163-165 ◽  
Author(s):  
K. John
Keyword(s):  
Medical Literature ◽  
Cost Effective ◽  
Medical Faculty ◽  
Bibliographic Databases ◽  
Literature Searches ◽  
Selection Of

SummaryAs many bibliographic services in medicine are offered, literature searches in eight databases at DIMDI were performed to find out which database is most important in medicine. The distribution of publications from members of the medical faculty of Frankfurt University was examined. No save prediction is possible as to which database will yield most articles. Overlapping from different databases is often rather low. The selection of an appropriate database mix for sufficient recall and in a cost-effective manner.is a task for an experienced searcher.

P084 DEEP REMISSION WITH DOUBLE BIOLOGIC THERAPY: A SUCCESSFUL CASE OF COMBINATION USTEKINUMAB AND VEDOLIZUMAB FOR SEVERE REFRACTORY CROHN’S DISEASE

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S72-S72
Author(s):  
Ahmed Elmoursi ◽  
Courtney Perry ◽  
Terrence Barrett
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Combination Therapy ◽  
Clinical Remission ◽  
Biologic Therapy ◽  
Case Reports ◽  
Sigmoid Resection ◽  
Safety And Efficacy ◽  
Ileal Stricture

Abstract Background Stricturing Crohn’s disease (CD) constitutes a severe phenotype often associated with a high degree of morbidity (3). Surgical resection is first-line therapy for symptomatic strictures, but most patients relapse without subsequent medical therapy (4–5). Biologics are the mainstay for inducing and maintaining remission, but some cases are refractory despite maximum dosage of therapy. Reports of dual biological therapy (DBT) in refractory, stricturing CD are sparse, and prior case reports document only clinical remission (1). To contribute further knowledge regarding the use of DBT in stricturing CD, we present the case of a refractory CD patient who achieved deep remission with ustekinumab and vedolizumab. Case Presentation A 35 year old non-smoking, Caucasian male was referred to our clinic in 2014 for refractory CD complicated by multiple strictures. Prior to establishing care with us, he received two jejunal resections and a sigmoid resection. Previously failed therapies included azathioprine with infliximab, adalimumab, and certolizumab. He continued to progress under our care despite combination methotrexate/certolizumab, as well as methotrexate/golimumab. He underwent proctocolectomy with end ileostomy in 2015 and initiated vedolizumab q8weeks post-operatively. He reoccurred in 2018, when he presented with an ulcerated ileal stricture. He was switched from vedolizumab to ustekinumab q8weeks and placed on prednisone, but continued to progress, developing significant hematochezia requiring hospitalization and blood transfusions. Ileoscopy performed during hospital admission confirmed severe, ulcerating disease in the ileum with stricture. Ustekinumab dosing was increased to q4weeks, azathioprine was initiated, and he underwent stricturoplasty. Follow-up ileoscopy three months later revealed two ulcers in the neo- TI (Figure 1). Vedolizumab q8weeks was initiated in addition to ustekinumab q4weeks and azathioprine 125mg. After four months on this regimen the patient felt better, but follow-up ileoscopy showed two persistent ulcers in the neo-TI. Vedolizumab dosing interval was increased to q4weeks. After four months, subsequent ileoscopy demonstrated normal neo-TI (Figure 2). Histologic evaluation of biopsies confirmed deep remission of crohn’s disease. No adverse side effects have occurred with maximum doses of both ustekinumab and vedolizumab combination therapy. Discussion This case supports both the safety and efficacy of ustekinumab and vedolizumab dual biologic therapy for treatment of severe, refractory Crohn’s disease. While there are reports of DBT inducing clinical remission, this case supports efficacy for vedolizumab and ustekinumab combination therapy to induce deep histologic remission. Large practical clinical trials are needed to better investigate the safety and efficacy of DBT with vedolizumab and ustekinumab, but our case suggests this combination may be a safe and efficacious therapy for refractory CD patients.

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.

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.

scholarly journals Cardiovascular safety and efficacy of metformin-SGLT2i versus metformin-sulfonylureas in type 2 diabetes: systematic review and meta-analysis of randomized controlled trials

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Desye Gebrie ◽  
Desalegn Getnet ◽  
Tsegahun Manyazewal
Keyword(s):  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Combination Therapy ◽  
Adverse Events ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Sodium Glucose Cotransporter

AbstractDiabetes is a serious threat to global health and among the top 10 causes of death, with nearly half a billion people living with it worldwide. Treating patients with diabetes tend to become more challenging due to the progressive nature of the disease. The role and benefits of combination therapies for the management of type 2 diabetes are well-documented, while the comparative safety and efficacy among the different combination options have not been elucidated. We aimed to systematically synthesize the evidence on the comparative cardiovascular safety and efficacy of combination therapy with metformin-sodium-glucose cotransporter-2 inhibitors versus metformin-sulfonylureas in patients with type 2 diabetes. We searched MEDLINE-PubMed, Embase, Cochrane Library, and ClinicalTrials.gov up to 15 August 2019 without restriction in the year of publication. We included randomized controlled trials of patients with type 2 diabetes who were on metformin-sodium-glucose cotransporter-2 inhibitors or metformin-sulphonylureas combination therapy at least for a year. The primary endpoints were all-cause mortality and serious adverse events, and the secondary endpoints were cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke, hypoglycemia, and changes in glycated hemoglobin A1c (HbA1c), body weight, fasting plasma glucose, blood pressure, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol. We used a random-effects meta-analysis model to estimate mean differences for continuous outcomes and risk ratio for dichotomous outcomes. We followed PICOS description model for defining eligibility and the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) 2015 guidelines for reporting results. Of 3,190 citations, we included nine trials involving 10,974 participants. The pooled analysis showed no significant difference in all-cause mortality (risk ration [RR] = 0.93, 95% CI [0.52, 1.67]), serious adverse events (RR = 0.96, 95% CI [0.79, 1.17]) and adverse events (RR = 1.00, 95% CI [0.99, 1.02]) between the two, but in hypoglycemia (RR = 0.13, 95% CI [0.10, 0.17], P < 0.001). Participants taking metformin-sodium glucose cotransporter-2 inhibitors showed a significantly greater reduction in HbA1c (mean difference [MD] = − 0.10%, 95% CI [− 0.17, − 0.03], body weight (MD = − 4.57 kg, 95% CI [− 4.74, − 4.39], systolic blood pressure (MD = − 4.77 mmHg, 95% CI [− 5.39, − 4.16]), diastolic blood pressure (MD = − 2.07 mmHg, 95% CI [− 2.74, − 1.40], and fasting plasma glucose (MD = − 0.55 mmol/L, 95% CI [− 0.69, − 0.41]), p < 0.001. Combination therapy of metformin and sodium-glucose cotransporter-2 inhibitors is a safe and efficacious alternative to combination therapy of metformin and sulphonylureas for patients with type 2 diabetes who are at risk of cardiovascular comorbidity. However, there remains a need for additional long-term randomized controlled trials as available studies are very limited and heterogeneous.

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