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Post marketing surveillance

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https://www.readbyqxmd.com/read/29215814/safety-and-efficacy-of-b-domain-deleted-third-generation-recombinant-factor-viii-greengene-f%C3%A2-in-korean-patients-with-hemophilia-a-data-from-a-post-marketing-surveillance-study
#1
Soon Ki Kim, Ki Young Yoo, Kun Soo Lee, Taiju Hwang, Yong Mook Choi, Eun Jin Choi, Sang Kyu Park
BACKGROUND: New B-domain deleted third generation recombinant factor VIII (FVIII; GreenGene F™, beroctocog alfa) was launched in 2010. We determined safety and efficacy of GreenGene F™ during routine clinical practice in patients with hemophilia A over a period of 12 months. METHODS: From July 2010 to July 2014, a total of 136 hemophilia A patients were enrolled in a post-marketing surveillance (PMS) study. Among them, 134 patients were assessed for drug safety and 114 patients were analyzed for drug efficacy...
January 1, 2018: Journal of Korean Medical Science
https://www.readbyqxmd.com/read/29204333/development-and-application-of-two-semi-automated-tools-for-targeted-medical-product-surveillance-in-a-distributed-data-network
#2
John G Connolly, Shirley V Wang, Candace C Fuller, Sengwee Toh, Catherine A Panozzo, Noelle Cocoros, Meijia Zhou, Joshua J Gagne, Judith C Maro
Purpose of Review: An important component of the Food and Drug Administration's Sentinel Initiative is the active post-market risk identification and analysis (ARIA) system, which utilizes semi-automated, parameterized computer programs to implement propensity-score adjusted and self-controlled risk interval designs to conduct targeted surveillance of medical products in the Sentinel Distributed Database. In this manuscript, we review literature relevant to the development of these programs and describe their application within the Sentinel Initiative...
December 2017: Current Epidemiology Reports
https://www.readbyqxmd.com/read/29200865/medicines-regulation-in-africa-current-state-and-opportunities
#3
Margareth Ndomondo-Sigonda, Jacqueline Miot, Shan Naidoo, Alexander Dodoo, Eliangiringa Kaale
Sound regulatory systems are critical for protecting public health against use of medical products which do not meet international standards of quality, safety and efficacy. This review provides a summary of the current status of National Medicines Regulatory Authorities (NMRAs) in Africa, and various initiatives that have been established to improve their performance. All countries in Africa (except Sahrawi Republic), have NMRAs but their organizational set-up and functionality is variable. Some are located within Ministries of Health and others are semi-autonomous...
2017: Pharmaceutical Medicine
https://www.readbyqxmd.com/read/29200789/pharmacovigilance-a-public-health-priority-for-south-africa
#4
Ushma Mehta, Emma Kalk, Andrew Boulle, Portia Nkambule, Joey Gouws, Helen Rees, Karen Cohen
South Africa has been engaged in pharmacovigilance (PV) activities to assess the impact of adverse drug reactions on public safety and health for 40 years. Activities have evolved from passive regulatory reporting to encompass active surveillance systems. The HIV and AIDS and TB epidemics stimulated pharmacoepidemiological research into the risks associated with medicines used in the standardised regimens of mass treatment programmes. Specific safety concerns, supported by robust local cohort data, have prompted major changes to national and international treatment policies...
2017: South African Health Review
https://www.readbyqxmd.com/read/29188680/biomaterials-as-bone-graft-substitutes-for-spine-surgery-from-preclinical-results-to-clinical-study
#5
G Barbanti Bròdano, C Griffoni, A Nataloni, M Manfrini, G Giavaresi, S Bandiera, A Gasbarrini, S Terzi, R Ghermandi, G Tedesco, M Girolami, M Tognon, M Fini
Vertebral fusion is performed in order to stabilize the spine in the presence of degenerative, traumatic or oncological pathologies that alter its stability. The autologous bone, harvested from the patient’s iliac crest or from the lamina during surgery, is still considered the “gold standard” for spine fusion due to its osteogenic, osteoinductive and osteoconductive properties. However, several biological and synthetic bone substitutes have been introduced as alternatives for regenerating bone tissue...
October 2017: Journal of Biological Regulators and Homeostatic Agents
https://www.readbyqxmd.com/read/29185822/safety-and-efficacy-of-ipragliflozin-in-japanese-patients-with-type-2-diabetes-in-real-world-clinical-practice-interim-results-of-the-stella-long-term-post-marketing-surveillance-study
#6
Ichiro Nakamura, Hiroshi Maegawa, Kazuyuki Tobe, Hiromi Tabuchi, Satoshi Uno
BACKGROUND: Data regarding the efficacy and safety of sodium-glucose cotransporter 2 inhibitors in the real-world setting in Japan are limited. The STELLA-LONG TERM study is an ongoing 3-year post-marketing surveillance study of ipragliflozin in type 2 diabetes (T2D) patients. Here, we report the interim results (including 3-, 12-, and 24-month data). RESEARCH DESIGN AND METHODS: All Japanese patients with T2D who were first prescribed ipragliflozin between July 17, 2014, and October 15, 2015, at participating centers in Japan were registered in STELLA-LONG TERM...
November 29, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29180056/review-of-a-licensed-dengue-vaccine-inappropriate-subgroup-analyses-and-selective-reporting-may-cause-harm-in-mass-vaccination-programs
#7
Antonio L Dans, Leonila F Dans, Mary Ann D Lansang, Maria Asuncion A Silvestre, Gordon H Guyatt
Severe life-threatening dengue fever usually occurs when a child is infected by dengue virus a 2nd time. This is caused by a phenomenon called antibody dependent enhancement or ADE. Since dengue vaccines can mimic a first infection in seronegative children (those with no previous infection), a natural infection later in life could lead to severe disease. The possibility that dengue vaccines can cause severe dengue through ADE has led to serious concern regarding the safety of mass vaccination programs. A published meta-analysis addressed this safety issue for a new vaccine against dengue fever - Dengvaxia ™...
November 24, 2017: Journal of Clinical Epidemiology
https://www.readbyqxmd.com/read/29178842/a-non-interventional-observational-study-of-a-fixed-combination-of-pepsin-and-amino-acid-hydrochloride-in-patients-with-functional-dyspepsia
#8
Kristin Forssmann, Larissa Meier, Bernhard Uehleke, Cornelia Breuer, Rainer Stange
BACKGROUND: Functional dyspepsia (FD) is a gastrointestinal disorder characterized by recurrent and diverse symptoms and pathophysiology that remains unexplained following routine clinical investigation. Enzynorm®f is a pharmaceutical preparation comprising fixed amounts of pepsin of biological origin and organically bound acid in the form of amino acid hydrochloride. It is traditionally used as a mild agent to support gastric function and to stimulate the stomach's proteolytic activities in FD...
November 25, 2017: BMC Gastroenterology
https://www.readbyqxmd.com/read/29157020/pharmacokinetic-drug-evaluation-of-mepolizumab-for-the-treatment-of-severe-asthma-associated-with-persistent-eosinophilic-inflammation-in-adults
#9
Lakshmi Kallur, Alexei Gonzalez-Estrada, Frank Eidelman, Ves Dimov
Mepolizumab is a humanized monoclonal antibody that binds to and inactivates IL-5. It is available as a subcutaneous preparation. The practical application of mepolizumab is as an add-on therapy in the treatment of severe eosinophilic asthma. Areas covered: This article was created from a comprehensive literature search with information taken from meta-analyses, systematic reviews, and clinical trials of adults. The articles that have been selected evaluate the use of mepolizumab and its role in eosinophilic asthma...
November 21, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/29153952/surveillance-of-the-safety-and-efficacy-of-recombinant-human-soluble-thrombomodulin-in-patients-with-obstetrical-disseminated-intravascular-coagulation
#10
Takao Kobayashi, Masahiro Kajiki, Katsuhito Nihashi, Goichi Honda
BACKGROUND: Recombinant human soluble thrombomodulin (TM-α) has been shown to be useful in the treatment of disseminated intravascular coagulation (DIC) in a heparin-controlled study, and has been available for clinical use in Japan since 2008. However, use of TM-α for obstetrical DIC has not yet been established, so efficacy and safety were analyzed in 117 obstetrical DIC patients identified from post-marketing surveillance. MATERIALS AND METHODS: From June 2010 to March 2012, the cases of 117 patients with obstetrical DIC treated with TM-α were registered...
September 18, 2017: Thrombosis Research
https://www.readbyqxmd.com/read/29152884/economic-impacts-of-avian-influenza-outbreaks-in-kerala-india
#11
G Govindaraj, R Sridevi, S N Nandakumar, R Vineet, P Rajeev, M K Binu, V Balamurugan, H Rahman
This study assessed the short-run impact to poultry farmers, duck hatcheries, control costs, compensation paid to stakeholders (transfer payments) and market reactions on own and substitute product prices and backwater tourism (boat operators) due to avian influenza (AI) outbreaks in Kuttanad region of Kerala, India, during 2014. The primary data from 91 poultry farms (duck farms, broiler chicken and backyard poultry), four hatcheries and 90 backwater boat owners were collected through pre-tested schedules...
November 19, 2017: Transboundary and Emerging Diseases
https://www.readbyqxmd.com/read/29139248/-post-marketing-safety-surveillance-of-diemailing-kudiezi-injection-real-world-study-in-30-233-cases
#12
Xing Liao, Dan-Dan Yu, Yan-Ming Xie, Yun-Ling Zhang, Yan He, Yin Zhang, Yan Liu, Dan-Hui Yi, Yong-Yan Wang
This study was aimed to obtain the incidence of adverse drug reaction (ADR) of Diemailing Kudiezi injection, explore its characteristics, related risk factors and application in real world. A prospective single cohort study was conducted from 25 hospitals (including Chinese medicine hospitals and Western medicine hospitals) for 4 years. 30 233 consecutive inpatients using Diemailing Kudiezi injection were observed. Their general information was analyzed by using statistic frequency description. Association rules were used to analyze the correlation between comorbidities or drug combinations; the influential factors for ADRs were initially screened by using cross contingency method and Chi-square test, and then Group LASSAO method was used for further analysis...
August 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
https://www.readbyqxmd.com/read/29131033/adverse-reactions-to-biologics-in-psoriasis
#13
Stephen J Lockwood, Lisette M Prens, Alexa B Kimball
Psoriasis is a chronic autoimmune disease which affects millions of people worldwide. Not only can psoriasis itself be debilitating and significantly reduce an individual's quality of life, but it is also a risk factor for other systemic disorders, such as metabolic syndrome, cardiovascular disease, and malignancy. Tremendous strides were made in the treatment of psoriasis during the mid-to-late-20th century, including the emergence of topical corticosteroids and vitamin D analogs, methotrexate, systemic retinoids, and phototherapy...
2018: Current Problems in Dermatology
https://www.readbyqxmd.com/read/29128379/active-sms-based-influenza-vaccine-safety-surveillance-in-australian-children
#14
Alexis Pillsbury, Helen Quinn, Patrick Cashman, Alan Leeb, Kristine Macartney
INTRODUCTION: Australia's novel, active surveillance system, AusVaxSafety, monitors the post-market safety of vaccines in near real time. We analysed cumulative surveillance data for children aged 6 months to 4 years who received seasonal influenza vaccine in 2015 and/or 2016 to determine: adverse event following immunisation (AEFI) rates by vaccine brand, age and concomitant vaccine administration. METHODS: Parent/carer reports of AEFI occurring within 3 days of their child receiving an influenza vaccine in sentinel immunisation clinics were solicited by Short Message Service (SMS) and/or email-based survey...
November 8, 2017: Vaccine
https://www.readbyqxmd.com/read/29122449/long-term-effectiveness-of-the-zilver-ptx-drug-eluting-stent-for-femoropopliteal-peripheral-artery-disease-in-patients-with-no-patent-tibial-runoff-vessels-results-from-the-zilver-ptx-japan-post-market-surveillance-study
#15
Stefano Cipollari, Hiroyoshi Yokoi, Takao Ohki, Kimihiko Kichikawa, Masato Nakamura, Kimihiro Komori, Shinsuke Nanto, Erin E O'Leary, Aaron E Lottes, Alan T Saunders, Michael D Dake
PURPOSE: To evaluate 2-year results of the Zilver PTX (Cook Medical, Bloomington, Indiana) drug-eluting stent (DES) for femoropopliteal peripheral artery disease (PAD) in patients with no continuous patent infrapopliteal runoff arteries compared with patients with ≥ 1 continuous patent runoff vessels. MATERIALS AND METHODS: A retrospective analysis of patients with femoropopliteal PAD enrolled in the Zilver PTX Post-Market Surveillance Study in Japan was performed...
November 7, 2017: Journal of Vascular and Interventional Radiology: JVIR
https://www.readbyqxmd.com/read/29119538/safety-and-effectiveness-of-natalizumab-first-report-of-interim-results-of-post-marketing-surveillance-in-japan
#16
Takahiko Saida, Kazumasa Yokoyama, Ryusuke Sato, Haruki Makioka, Yukihiko Iizuka, Masakazu Hase, Yan Ling, Shinichi Torii
INTRODUCTION: Natalizumab, a humanized anti-α4 integrin monoclonal antibody, received marketing approval in Japan in 2014 for the treatment of multiple sclerosis (MS). Because the previous large-scale clinical trials of natalizumab were mainly conducted in Europe and North American countries, and data in patients with MS from Japan were limited, we conducted an all-case post-marketing surveillance of natalizumab-treated MS patients from Japan to investigate the safety and effectiveness of natalizumab in a real-world clinical setting in Japan...
November 8, 2017: Neurology and Therapy
https://www.readbyqxmd.com/read/29096801/outcomes-with-transcatheter-mitral-valve-repair-in-the-united-states-an-sts-acc-tvt-registry-report
#17
Paul Sorajja, Sreekanth Vemulapalli, Ted Feldman, Michael Mack, David R Holmes, Amanda Stebbins, Saibal Kar, Vinod Thourani, Gorav Ailawadi
BACKGROUND: Post-market surveillance is needed to evaluate the real-world clinical effectiveness and safety of U.S. Food and Drug Administration-approved devices. OBJECTIVES: The authors examined the commercial experience with transcatheter mitral valve repair for the treatment of mitral regurgitation. METHODS: Data from the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with transcatheter mitral valve repair were analyzed...
November 7, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/29081385/toward-multimodal-signal-detection-of-adverse-drug-reactions
#18
Rave Harpaz, William DuMouchel, Martijn Schuemie, Olivier Bodenreider, Carol Friedman, Eric Horvitz, Anna Ripple, Alfred Sorbello, Ryen W White, Rainer Winnenburg, Nigam H Shah
OBJECTIVE: Improving mechanisms to detect adverse drug reactions (ADRs) is key to strengthening post-marketing drug safety surveillance. Signal detection is presently unimodal, relying on a single information source. Multimodal signal detection is based on jointly analyzing multiple information sources. Building on, and expanding the work done in prior studies, the aim of the article is to further research on multimodal signal detection, explore its potential benefits, and propose methods for its construction and evaluation...
October 25, 2017: Journal of Biomedical Informatics
https://www.readbyqxmd.com/read/29080984/benefit-risk-assessment-of-crataegus-extract-ws%C3%A2-1442-an-evidence-based-review
#19
REVIEW
Christian J F Holubarsch, Wilson S Colucci, Jaan Eha
Preparations from Crataegus (hawthorn) have a long history in the treatment of heart failure. WS 1442 is a dry extract from hawthorn leaves with flowers (4-6.6:1), extraction solvent of ethanol 45% (w/w), adjusted to 17.3-20.1% of oligomeric procyanidins. Nonclinical studies show that WS 1442 has positive inotropic and antiarrhythmic properties and protects the myocardium from ischemic damage, reperfusion injury, and hypertension-related hypertrophy, improves endothelial functions such as NO synthesis, and delays endothelial senescence...
October 28, 2017: American Journal of Cardiovascular Drugs: Drugs, Devices, and Other Interventions
https://www.readbyqxmd.com/read/29080523/fatal-poisonings-involving-propoxyphene-before-and-after-voluntary-withdrawal-from-the-united-states-market-an-analysis-from-the-state-of-florida
#20
Chris Delcher, Guanming Chen, Yanning Wang, Svetla Slavova, Bruce A Goldberger
The synthetic opioid propoxyphene was a schedule IV controlled substance with multiple reported health risks before the US Food and Drug Administration issued a request for voluntary market withdrawal in November 2010. The purpose of this study is to investigate the characteristics and occurrences of propoxyphene-related deaths in Florida before and after voluntary market removal. Decedent-level toxicology data from Florida's Medical Examiners Commission was used to compare the temporal, polysubstance use, sociodemographic, and geographic profiles associated with propoxyphene-involved deaths for a pre-withdrawal (November 2008-November 2010) and post-withdrawal (December 2010-December 2012) period...
November 2017: Forensic Science International
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