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https://www.readbyqxmd.com/read/28804696/neonatal-safety-information-reported-to-the-fda-during-drug-development-studies
#1
Debbie Avant, Gerri Baer, Jason Moore, Panli Zheng, Alfred Sorbello, Ron Ariagno, Lynne Yao, Gilbert J Burckart, Jian Wang
BACKGROUND: Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates is complicated by the unique nature of the population and the level of illness. The objective of this study was to examine neonatal safety data submitted to the FDA in studies pursuant to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) between 1998 and 2015...
2017: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/28803741/the-cardiovascular-toxicity-of-triadimefon-in-early-life-stage-of-zebrafish-and-potential-implications-to-human-health
#2
Hong-Cui Liu, Tian-Yi Chu, Li-Li Chen, Wen-Jun Gui, Guo-Nian Zhu
The health risk of triadimefon (TF) to cardiovascular system of human is still unclear, especially to pesticide suicides population, occupational population (farmers, retailers and pharmaceutical workers), and special population (young children and infants, pregnant women, older people, and those with compromised immune systems) who are at a greater risk. Therefore, firstly we explored the toxic effects and possible mechanism of cardiovascular toxicity induced by TF using zebrafish model. Zebrafish at stage of 48 h post fertilization (hpf) exposed to TF for 24 h exhibited morphological malformations which were further confirmed by histopathologic examination, including pericardial edema, circulation abnormalities, serious venous thrombosis and increased distance between the sinus venosus (SV) and bulbus arteriosus (BA) regions of the heart...
August 10, 2017: Environmental Pollution
https://www.readbyqxmd.com/read/28802598/effect-of-parecoxib-sodium-pretreatment-combined-with-dexmedetomidine-on-early-postoperative-cognitive-dysfunction-in-elderly-patients-after-shoulder-arthroscopy-a-randomized-double-blinded-controlled-trial
#3
Jian Lu, Gang Chen, Hongmei Zhou, Qinghe Zhou, Zhipeng Zhu, Cheng Wu
STUDY OBJECTIVE: To evaluate effect of parecoxib sodium pretreatment combined with dexmedetomidine on early postoperative cognitive dysfunction in elderly patients after shoulder arthroscopy. DESIGN: Randomized, double-blind study. SETTING: University-affiliated teaching hospital. PATIENTS: One hundred and fifty-two elderly patients scheduled for shoulder arthroscopy. INTERVENTIONS: At 15min before the induction of anesthesia, 152 patients received intravenously parecoxib sodium 40mg and dexmedetomidine at a dose of 0...
September 2017: Journal of Clinical Anesthesia
https://www.readbyqxmd.com/read/28798290/bradycardia-and-hypothermia-complicating-azithromycin-treatment
#4
Kerri Benn, Sam Salman, Madhu Page-Sharp, Timothy M E Davis, Jim P Buttery
BACKGROUND Azithromycin is a macrolide antibiotic widely used to treat respiratory, urogenital, and other infections. Gastrointestinal upset, headache, and dizziness are common adverse effects, and prolongation of the rate-corrected electrocardiographic QT interval and malignant arrhythmias have been reported. There are rare reports of bradycardia and hypothermia but not in the same patient. CASE REPORT A 4-year-old boy given intravenous azithromycin as part of treatment for febrile neutropenia complicating leukemia chemotherapy developed hypothermia (rectal temperature 35...
August 11, 2017: American Journal of Case Reports
https://www.readbyqxmd.com/read/28798230/association-of-bmi-with-propofol-dosing-and-adverse-events-in-children-with-cancer-undergoing-procedural-sedation
#5
Colin M Rogerson, Kamal Abulebda, Michael J Hobson
OBJECTIVES: Obesity increases the risk of complications during pediatric procedural sedation. The risk of being underweight has not been evaluated in this arena. We therefore investigated the association of BMI with sedation dosing and adverse events in children across a range of BMIs. METHODS: A total of 1976 patients ages 2 to 21 years old with oncologic diagnoses underwent lumbar punctures and/or bone marrow aspirations. All children received a standard adjunctive dose of ketamine before sedation with propofol...
August 10, 2017: Hospital Pediatrics
https://www.readbyqxmd.com/read/28794360/clonazepam-associated-bradycardia-in-a-disabled-elderly-woman-with-multiple-complications
#6
Hidetomo Maruyoshi, Natsue Maruyoshi, Motone Hirosue, Komei Ikeda, Masaaki Shimamoto
We herein report an 87-year-old woman who was taking clonazepam at 1.5 mg/day. She was hospitalized with an old cerebral infarction complicated with symptomatic epilepsy, dementia, dyslipidemia, and chronic cholecystitis. Electrocardiogram revealed severe bradycardia at 31 beats/min. The bradycardia disappeared on day 3 after clonazepam withdrawal, although the serum clonazepam level had been within normal limits. She was diagnosed with clonazepam-associated bradycardia, which was likely related to the potential calcium channel-blocking properties of clonazepam...
August 10, 2017: Internal Medicine
https://www.readbyqxmd.com/read/28792725/pharmacology-of-cumyl-carboxamide-synthetic-cannabinoid-new-psychoactive-substances-nps-cumyl-bica-cumyl-pica-cumyl-5f-pica-cumyl-5f-pinaca-and-their-analogues
#7
Mitchell Longworth, Samuel D Banister, Rochelle Boyd, Richard C Kevin, Mark Connor, Iain S McGregor, Michael Kassiou
Synthetic cannabinoids (SC) are the largest class of new psychoactive substances (NPS), and are increasingly associated with serious adverse effects. The majority of SC NPS are 1,3-disubstituted indoles and indazoles featuring a diversity of subunits at the 1- and 3-positions. Most recently, cumyl-derived indole- and indazole-3-carboxamides have been detected by law enforcement agencies and by emergency departments. Herein we describe the synthesis, characterization, and pharmacology of SCs CUMYL-BICA, CUMYL-PICA, CUMYL-5F-PICA, CUMYL-PINACA, CUMYL-5F-PINACA, and related analogues...
August 11, 2017: ACS Chemical Neuroscience
https://www.readbyqxmd.com/read/28745218/ventricular-extrasystoles-after-first-dose-of-sofosbuvir-in-a-patient-treated-with-propranolol-but-not-with-amiodarone-a-case-report
#8
Samir Rouabhia, Sabah Baghazza, Hamza Sadouki, Sihem Djezzar, Rafik Bencherif, Rofia Guehimeche, Mourad Sadelaoud, Djamel Mallem, Karima Chaabna
BACKGROUND: Sofosbuvir is a direct-acting antiviral drug used to treat chronic hepatitis C infection. In 2015, Gilead Sciences, the manufacturer of sofosbuvir, warned that bradycardia could occur when sofosbuvir is administered in combination with amiodarone. Interestingly, among reported cases of patients with sofosbuvir and amiodarone related bradycardia, some of them were also treated with propranolol. OBJECTIVE: We herein report a case of ventricular extrasystoles within three hours after the coadministration of sofosbuvir-containing regimen with propranolol...
July 25, 2017: Reviews on Recent Clinical Trials
https://www.readbyqxmd.com/read/28732259/dravet-syndrome-characteristics-comorbidities-and-caregiver-concerns
#9
Nicole Villas, Mary Anne Meskis, Sue Goodliffe
The Dravet Syndrome Foundation (DSF) conducted the largest in-depth survey of parents and caregivers of patients with Dravet syndrome (DS) to date, in order to (1) identify top concerns among caregivers, (2) establish an approximate frequency of characteristics and comorbidities of DS beyond seizures, and (3) provide direction for clinicians and researchers looking to study the effects of DS on the patient and family unit. Two hundred fifty-six responses were received representing a patient age range of 9months to 32years with a median age group of 7-10years (IQR=8)...
July 18, 2017: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/28728750/trigeminocardiac-reflex-during-non-surgical-root-canal-treatment-of-teeth-with-irreversible-pulpitis
#10
James I-Sheng Huang, Hao-Hueng Chang, Chun-Pei Lin, Wan-Chuen Liao, Chia-Tze Kao, Tsui-Hsien Huang
BACKGROUND/PURPOSE: Trigeminocardiac reflex (TCR) is a unique clinical incident of acute change in hemodynamic balance, which may lead to hypotension, bradycardia, and even clinical crisis. Up to date, no study so far considers the impact of non-surgical root canal treatment (NSRCT) of irreversible pulpitis teeth under either local infiltration or block anesthesia on hemodynamic change possibly related to TCR. METHODS: This study enrolled 111 patients with 138 irreversible pulpitis teeth that were treated by two sessions of NSRCT...
July 17, 2017: Journal of the Formosan Medical Association, Taiwan Yi Zhi
https://www.readbyqxmd.com/read/28720838/the-efficacy-and-safety-of-sugammadex-for-reversing-postoperative-residual-neuromuscular-blockade-in-pediatric-patients-a-systematic-review
#11
Guangyu Liu, Rui Wang, Yanhong Yan, Long Fan, Jixiu Xue, Tianlong Wang
The aim of this study is to evaluate the efficacy and safety of sugammadex for reversing neuromuscular blockade in pediatric patients. MEDLINE and other three Databases were searched. Randomized clinical trials were included if they compared sugammadex with neostigmine or placebo in pediatric patients undergoing surgery involving the use of rocuronium or vecuronium. The primary outcome was the time interval from administration of reversal agents to train-of-four ratio (TOFr, T4/T1) > 0.9. Incidences of any drug-related adverse events were secondary outcomes...
July 18, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28709838/characteristics-of-scrub-typhus-murine-typhus-and-q-fever-among-elderly-patients-prolonged-prothrombin-time-as-a-predictor-for-severity
#12
Ko Chang, Nan-Yao Lee, Wen-Chien Ko, Wei-Ru Lin, Yen-Hsu Chen, Jih-Jin Tsai, Tun-Chieh Chen, Chun-Yu Lin, Ya-Ting Chang, Po-Liang Lu
BACKGROUND/PURPOSE: The clinical manifestations of scrub typhus, murine typhus and acute Q fever in the elderly are not clear. METHODS: We conducted a retrospective study to identify the characteristics of the elderly aged ≥65 years with a comparison group aged 18-64 years among patients with scrub typhus, murine typhus, or acute Q fever who were serologically confirmed at three hospitals in Taiwan during 2002-2011. RESULTS: Among 441 cases, including 187 cases of scrub typhus, 166 acute Q fever, and 88 murine typhus, 68 (15...
June 22, 2017: Journal of Microbiology, Immunology, and Infection, Wei Mian Yu Gan Ran za Zhi
https://www.readbyqxmd.com/read/28689383/-apnea-of-prematurity-characteristic-and-treatment
#13
Aleksandra Goryniak, Angelika Szczęśniak, Daria Śleboda, Barbara Dołęgowska
Apnea of prematurity (AOP) can affect even 85-100% of premature newborns and is related to lack of full maturity of organs. AOP is manifesting by 15-20 seconds cessations of breathing accompanied by bradycardia and oxygen desaturation, what can lead to hypoxia or death. Therefore it is very important to implement the effective and safe treatment immediately after birth. Widely used caffeine citrate, which stimulates the respiratory system, improving the working of the respiratory muscles. However the metabolism of caffeine citrate is difficult in preterm infants due to the immaturity of the hepatic enzyme system, what can lead to the occurrence of side effects and toxicity...
2017: Postepy Biochemii
https://www.readbyqxmd.com/read/28684901/comparison-of-posttransplant-outcomes-in-patients-with-no-acute-or-chronic-amiodarone-use-before-heart-transplantation
#14
Rasmus Rivinius, Matthias Helmschrott, Arjang Ruhparwar, Fabrice F Darche, Dierk Thomas, Tom Bruckner, Hugo A Katus, Andreas O Doesch
BACKGROUND: Major concerns about the safety of pretransplant amiodarone use have been raised. As a result of its long half-life, the cardiac allograft is exposed to amiodarone posing potential risks such as bradycardia, requirement for pacemaker implantation, or increased mortality after heart transplantation (HTX). OBJECTIVE: The aim of this study is to investigate the posttransplant outcomes of patients with no, acute, or chronic amiodarone use before HTX. METHODS: This retrospective single-center study included 530 adult patients who received HTX between 06/1989 and 12/2012...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28668627/vigabatrin-lacks-proarrhythmic-potential-results-from-a-thorough-qt-qtc-study-in-healthy-volunteers
#15
Dwain Tolbert, Susan Reid, Stuart Harris, Ihor Bekersky
PURPOSE: A thorough QT study was performed to assess the proarrhythmic potential of vigabatrin, an antiepileptic drug approved in the United States for the treatment of infantile spasms and refractory complex partial seizures. METHODS: In this Phase I, randomized, double-blind, placebo- and active-controlled (moxifloxacin), 4-sequence, crossover study conducted at a single center, healthy participants received 1 of 4 randomly assigned treatments: 3.0g vigabatrin solution (therapeutic dose) and 1 moxifloxacin placebo tablet; 6...
June 28, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28667196/patient-safety-during-procedural-sedation-using-capnography-monitoring-a-systematic-review-and-meta-analysis
#16
Rhodri Saunders, Michel M R F Struys, Richard F Pollock, Michael Mestek, Jenifer R Lightdale
OBJECTIVE: To evaluate the effect of capnography monitoring on sedation-related adverse events during procedural sedation and analgesia (PSA) administered for ambulatory surgery relative to visual assessment and pulse oximetry alone. DESIGN AND SETTING: Systematic literature review and random effects meta-analysis of randomised controlled trials (RCTs) reporting sedation-related adverse event incidence when adding capnography to visual assessment and pulse oximetry in patients undergoing PSA during ambulatory surgery in the hospital setting...
June 30, 2017: BMJ Open
https://www.readbyqxmd.com/read/28663645/prophylactic-use-of-intravenous-clonidine-compared-to-tramadol-in-prevention-of-intraoperative-shivering-under-regional-anesthesia
#17
Sarmila Guha Banerjee, Pallab Kumar Nath, Rita Halder, Ujjwal Bandyopadhyay
OBJECTIVES: This study aimed to evaluate the relative efficacy of prophylactic intravenous (IV) clonidine and tramadol for control of intraoperative shivering following spinal anesthesia. MATERIALS AND METHODS: After institutional ethical clearance, 142 patients were chosen from either gender, aged 20-60 years, physical status American Society of Anesthesiology Class I and II scheduled for elective infraumbilical surgery under spinal anesthesia. Patients were randomized into two groups: Group C (n = 71) received injection clonidine 50 μg) IV in 100 ml normal saline (NS) over 10 min and Group T (n = 71) received injection tramadol 50 mg IV...
April 2017: Anesthesia, Essays and Researches
https://www.readbyqxmd.com/read/28660467/influence-of-dexmedetomidine-on-cardiac-complications-in-non-cardiac-surgery-a-meta-analysis-of-randomized-trials
#18
Shuan Jin, Xueyue Zhou
Background The cardiac protection of dexmedetomidine (Dex) in peri-operative period of patients with non-cardiac surgery is still controversial. Aim of the Review We aimed to evaluate the influence of Dex on cardiac complications in peri-operative period of non-cardiac surgery by using a meta-analysis. Methods PubMed, Embase, the Cochrane library and Springer databases were searched for relevant studies. Patients in the eligible studies were divided into Dex group and placebo group. Relative risk (RR) and the 95 % confidence interval (CI) were calculated to evaluate the outcomes including all-cause mortality, myocardial infarction, myocardial ischaemia, hypotension and bradycardia...
August 2017: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/28654510/late-ina-inhibition-as-an-antiarrhythmic-strategy
#19
Alexander Burashnikov
Late sodium channel current (late INa) is considered to be an anti-arrhythmic target. The prime anti-arrhythmic mechanisms of late INa inhibition have been suggested to be 1) suppression of intracellular calcium [Cai]-mediated rhythmic activity (via reduction of Cai secondary to the decrease of intracellular sodium [Nai]) and 2) normalization of repolarization. Endogenous late INa is a small current and acceleration of heart rate decreases late INa density. Late INa influx may significantly contribute to Nai loading, but it appears to largely occur in the combined conditions of augmented late INa density, bradycardia, and prolonged repolarization...
June 22, 2017: Journal of Cardiovascular Pharmacology
https://www.readbyqxmd.com/read/28644847/role-of-classic-signs-as-diagnostic-predictors-for-enteric-fever-among-returned-travellers-relative-bradycardia-and-eosinopenia
#20
Takashi Matono, Satoshi Kutsuna, Yasuyuki Kato, Yuichi Katanami, Kei Yamamoto, Nozomi Takeshita, Kayoko Hayakawa, Shuzo Kanagawa, Mitsuo Kaku, Norio Ohmagari
BACKGROUND: The lack of characteristic clinical findings and accurate diagnostic tools has made the diagnosis of enteric fever difficult. We evaluated the classic signs of relative bradycardia and eosinopenia as diagnostic predictors for enteric fever among travellers who had returned from the tropics or subtropics. METHODS: This matched case-control study used data from 2006 to 2015 for culture-proven enteric fever patients as cases. Febrile patients (>38.3°C) with non-enteric fever, who had returned from the tropics or subtropics, were matched to the cases in a 1:3 ratio by age (±3 years), sex, and year of diagnosis as controls...
2017: PloS One
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