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Post marketing surveillance

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https://www.readbyqxmd.com/read/28231676/-post-marketing-surveillance-of-tanreqing-injection-in-children-a-real-world-study
#1
X X Li, L Zhuo, Y H Yang, S Y Zhan, S D Zhai
Objective: To evaluate the safety of Tanreqing injection among children in the real world. Methods: A multicenter, large sample, ambispective cohort study, with registration-type clinical safety monitoring. A total of 6 188 inpatients and patients from the emergency units, aged ≤ 14 years who all had been using Tanreqing injection in 59 secondary and tertiary hospitals in China, were recruited between January, 2014 and May, 2015. The main outcomes would include incidence and severity of adverse drug reaction (ADR)/adverse drug event (ADE) of Tanreqing injection...
February 10, 2017: Zhonghua Liu Xing Bing Xue za Zhi, Zhonghua Liuxingbingxue Zazhi
https://www.readbyqxmd.com/read/28227018/using-constrained-information-entropy-to-detect-rare-adverse-drug-reactions-from-medical-forums
#2
Yi Zheng, Chaowang Lan, Hui Peng, Jinyan Li, Yi Zheng, Chaowang Lan, Hui Peng, Jinyan Li, Jinyan Li, Hui Peng, Chaowang Lan, Yi Zheng
Adverse drug reactions (ADRs) detection is critical to avoid malpractices yet challenging due to its uncertainty in pre-marketing review and the underreporting in post-marketing surveillance. To conquer this predicament, social media based ADRs detection methods have been proposed recently. However, existing researches are mostly co-occurrence based methods and face several issues, in particularly, leaving out the rare ADRs and unable to distinguish irrelevant ADRs. In this work, we introduce a constrained information entropy (CIE) method to solve these problems...
August 2016: Conference Proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society
https://www.readbyqxmd.com/read/28223094/a-decade-of-the-catalonian-arthroplasty-register-racat-variability-exhaustivity-and-survival-of-prostheses-between-2005-and-2014
#3
J Arias-de la Torre, A Capdevila, O Martínez, L Domingo, M Marinelli, N Robles, J Nardi, L Puig-Verdié, F Pallisó, M Espallargues
BACKGROUND AND AIM: The Catalonian Arthroplasty Register (RACat) is a public health-based population register used to analyse and evaluate hip and knee replacements in Catalonia. The aim of this study is to present the outcomes after 10 years in operation (January 2005-December 2014). METHODOLOGY: Using the information from the RACat and the minimum basic data set at hospital discharge, an analysis was made of the quality and exhaustivity of the data, as well as a descriptive analysis of the patients, prostheses, and care process...
February 17, 2017: Revista Española de Cirugía Ortopédica y Traumatología
https://www.readbyqxmd.com/read/28216355/innovative-postmarket-device-evaluation-using-a-quality-registry-to-monitor-thoracic-endovascular-aortic-repair-in-the-treatment-of-aortic-dissection
#4
Adam W Beck, Joseph V Lombardi, Dorothy B Abel, J Pablo Morales, Danica Marinac-Dabic, Grace Wang, Ali Azizzadeh, John Kern, Mark Fillinger, Rodney White, Jack L Cronenwett, Richard P Cambria
OBJECTIVE: United States Food and Drug Administration (FDA)-mandated postapproval studies have long been a mainstay of the continued evaluation of high-risk medical devices after initial marketing approval; however, these studies often present challenges related to patient/physician recruitment and retention. Retrospective single-center studies also do not fully represent the spectrum of real-world performance nor are they likely to have a sufficiently large enough sample size to detect important signals...
February 16, 2017: Journal of Vascular Surgery
https://www.readbyqxmd.com/read/28192490/safety-of-measles-containing-vaccines-in-post-marketing-surveillance-in-anhui-china
#5
Fan-Ya Meng, Yong Sun, Yong-Gang Shen, Hai-Feng Pan, Ji-Hai Tang, Bin-Bing Wang, Chang-Hao Wu, Dong-Qing Ye
The safety of measles vaccination is of great interest and importance to public health practice and the general society. We have analyzed the adverse events following immunization (AEFIs) of currently used measles-containing vaccines (including live attenuated measles vaccine, live attenuated measles and rubella combined vaccine, live attenuated measles and mumps combined vaccine, live attenuated Measles, Mumps and Rubella Combined Vaccine) in Anhui Province, China. From 2009 to 2014, 9.9 million doses of measles-containing vaccines were administrated and 1893 AEFIs were found (191...
2017: PloS One
https://www.readbyqxmd.com/read/28190666/design-of-a-framework-for-the-deployment-of-collaborative-independent-rare-disease-centric-registries-gaucher-disease-registry-model
#6
Matthew I Bellgard, Kathryn R Napier, Alan H Bittles, Jeffrey Szer, Sue Fletcher, Nikolajs Zeps, Adam A Hunter, Jack Goldblatt
Orphan drug clinical trials often are adversely affected by a lack of high quality treatment efficacy data that can be reliably compared across large patient cohorts derived from multiple governmental and country jurisdictions. It is critical that these patient data be captured with limited corporate involvement. For some time, there have been calls to develop collaborative, non-proprietary, patient-centric registries for post-market surveillance of aspects related to orphan drug efficacy. There is an urgent need for the development and sustainable deployment of these 'independent' registries that can capture comprehensive clinical, genetic and therapeutic information on patients with rare diseases...
January 27, 2017: Blood Cells, Molecules & Diseases
https://www.readbyqxmd.com/read/28174182/contribution-of-industry-funded-post-marketing-studies-to-drug-safety-survey-of-notifications-submitted-to-regulatory-agencies
#7
Angela Spelsberg, Christof Prugger, Peter Doshi, Kerstin Ostrowski, Thomas Witte, Dieter Hüsgen, Ulrich Keil
OBJECTIVES:  To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. DESIGN:  Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. SETTING:  Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany...
February 7, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28161880/long-term-safety-and-efficacy-of-omnitrope-%C3%A2-in-adults-with-growth-hormone-deficiency-italian-interim-analysis-of-the-patro-adults-study
#8
D Ferone, E Profka, V Gasco, M R Ambrosio, A Colao, C Di Somma, E Puxeddu, G Arnaldi, C Pagano, E Zecchi, A Pietropoli, P Beck-Peccoz
PURPOSE: To report the long-term effectiveness and safety of the recombinant human growth hormone Omnitrope(®), a somatropin biosimilar to Genotropin(®), in Italian patients with growth hormone deficiency (GHD) enrolled in the PATRO Adults study. METHODS: The PATRO Adults study is an ongoing observational, longitudinal, non-interventional global post-marketing surveillance study, conducted in several European countries. The primary endpoint is long-term safety; secondary endpoints include the effectiveness of Omnitrope(®), which was assessed using serum insulin-like growth factor-1 levels, body composition, bone mineral density and lipid levels...
February 4, 2017: Journal of Endocrinological Investigation
https://www.readbyqxmd.com/read/28158568/pemetrexed-related-interstitial-lung-disease-reported-from-post-marketing-surveillance-malignant-pleural-mesothelioma-non-small-cell-lung-cancer
#9
Keisuke Tomii, Terufumi Kato, Masashi Takahashi, Satoshi Noma, Yoichiro Kobashi, Sotaro Enatsu, Sumiko Okubo, Noriko Kobayashi, Shoji Kudoh
No abstract text is available yet for this article.
February 2, 2017: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28155198/validation-of-new-signal-detection-methods-for-web-query-log-data-compared-to-signal-detection-algorithms-used-with-faers
#10
Susan Colilla, Elad Yom Tov, Ling Zhang, Marie-Laure Kurzinger, Stephanie Tcherny-Lessenot, Catherine Penfornis, Shang Jen, Danny S Gonzalez, Patrick Caubel, Susan Welsh, Juhaeri Juhaeri
INTRODUCTION: Post-marketing drug surveillance is largely based on signals found in spontaneous reports from patients and healthcare providers. Rare adverse drug reactions and adverse events (AEs) that may develop after long-term exposure to a drug or from drug interactions may be missed. The US FDA and others have proposed that web-based data could be mined as a resource to detect latent signals associated with adverse drug reactions. METHODS: Recently, a web-based search query method called a query log reaction score (QLRS) was developed to detect whether AEs associated with certain drugs could be found from search engine query data...
February 2, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28134628/when-is-a-fracture-not-fresh-aligning-reimbursement-with-patient-outcome
#11
Robert Zura, Zekun Jack Xu, Gregory J Della Rocca, Samir Mehta, R Grant Steen
OBJECTIVE: The clinical value of low-intensity pulsed ultrasound (LIPUS) for fresh fracture is known. Yet in the absence of a definition of what "fresh" is, payers have adopted study inclusion criteria drawn from randomized clinical trials as de facto definitions of which patients should be treated, with "fresh" defined as <1 week old. Fracture patients may thus be ineligible for LIPUS treatment after week 1, which potentially denies access to patients who could benefit from LIPUS...
February 15, 2017: Journal of Orthopaedic Trauma
https://www.readbyqxmd.com/read/28130774/pre-exposure-prophylaxis-for-hiv-prevention-safety-concerns
#12
REVIEW
Raymond A Tetteh, Barbara A Yankey, Edmund T Nartey, Margaret Lartey, Hubert G M Leufkens, Alexander N O Dodoo
Available evidence supports the efficacy of pre-exposure prophylaxis (PrEP) in decreasing the incidence of human immunodeficiency virus (HIV) infection among high-risk individuals, especially when used in combination with other behavioural preventive methods. Safety concerns about PrEP present challenges in the implementation and use of PrEP. The aim of this review is to discuss safety concerns observed in completed clinical trials on the use of PrEP. We performed a literature search on PrEP in PubMed, global advocacy for HIV prevention (Aids Vaccine Advocacy Coalition) database, clinical trials registry " http://www...
January 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28130659/pitavastatin-a-review-in-hypercholesterolemia
#13
Sheridan M Hoy
Oral pitavastatin (Livalo(®); Livazo(®)) is a competitive HMG-CoA reductase inhibitor that is available in the EU for the reduction of elevated total cholesterol and low-density lipoprotein cholesterol (LDL-C) levels in adults with primary hypercholesterolemia and combined (mixed) dyslipidemia. In short-term, phase III or IV studies in this patient population, pitavastatin 1-4 mg once daily was generally no less effective than presumed equipotent dosages of atorvastatin and simvastatin (including in patients with type 2 diabetes or ≥2 cardiovascular risk factors) and was superior to pravastatin (including in patients aged ≥65 years) in lowering LDL-C levels...
January 27, 2017: American Journal of Cardiovascular Drugs: Drugs, Devices, and Other Interventions
https://www.readbyqxmd.com/read/28125608/post-marketing-safety-surveillance-of-the-salvia-miltiorrhiza-depside-salt-for-infusion-a-real-world-study
#14
Ying-Ying Yan, Yi-Heng Yang, Wei-Wei Wang, Yu-Ting Pan, Si-Yan Zhan, Ming-Yang Sun, Hong Zhang, Suo-Di Zhai
BACKGROUND: Salvia Miltiorrhiza Depside Salt for Infusion (SMDS) is made of a group of highly purified listed drugs. However, its safety data is still reported limitedly. Compared with the clinical trials, its safety in the real world setting is barely assessed. OBJECTIVE: To investigate the safety issues, including adverse events (AEs), adverse events related to SMDS (ADEs), and adverse drug reactions (ADRs) of the SMDS in the real world clinical practice. METHODS: This is a prospective, multicenter, pharmacist-led, cohort study in the real world setting...
2017: PloS One
https://www.readbyqxmd.com/read/28119747/safety-and-effectiveness-of-indacaterol-in-chronic-obstructive-pulmonary-disease-patients-in-south-korea
#15
Ho-Kee Yum, Hak-Ryul Kim, Yoon Soo Chang, Kyeong-Cheol Shin, Song Kim, Yeon-Mok Oh
BACKGROUND: Inhaled indacaterol (Onbrez Breezhaler), a long-acting β2-agonist, is approved in over 100 countries, including South Korea, as a once-daily bronchodilator for maintenance and treatment of chronic obstructive pulmonary disease (COPD). Here, we present an interim analysis of a post-marketing surveillance study conducted to evaluate the real-world safety and effectiveness of indacaterol in the Korean population. METHODS: This was an open-label, observational, prospective study in which COPD patients, who were newly prescribed with indacaterol (150 or 300 µg), were evaluated for 12 or 24 weeks...
January 2017: Tuberculosis and Respiratory Diseases
https://www.readbyqxmd.com/read/28104414/dissolution-failure-of-solid-oral-drug-products-in-field-alert-reports
#16
Dajun Sun, Meng Hu, Mark Browning, Rick L Friedman, Wenlei Jiang, Liang Zhao, Hong Wen
From 2005 to 2014, 370 data entries of dissolution failures of solid oral drug products were assessed with respect to the solubility of drug substances, dosage forms [immediate release (IR) vs. modified release (MR)], and manufacturers (brand name vs. generic). The study results show that the solubility of drug substances does not play a significant role in dissolution failures; however, MR drug products fail dissolution tests more frequently than IR drug products. When multiple variables were analyzed simultaneously, poorly water-soluble IR drug products failed the most dissolution tests, followed by poorly soluble MR drug products and very soluble MR drug products...
January 17, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28097680/development-of-a-novel-algorithm-for-detecting-glucocorticoid-induced-diabetes-mellitus-using-a-medical-information-database
#17
T Imatoh, K Sai, K Hori, K Segawa, J Kawakami, M Kimura, Y Saito
WHAT IS KNOWN AND OBJECTIVE: Glucocorticoid-induced diabetes mellitus (GIDM) increases the risk of diabetes mellitus (DM)-related complications but is generally difficult to detect in clinical settings. The criteria for diagnosing GIDM have not been established. Recently, medical information databases (MIDs) have been used in post-marketing surveillance (PMS) studies. We conducted a pharmacoepidemiological study to develop an algorithm for detecting GIDM using MID. METHODS: We selected 1214 inpatients who were newly prescribed with a typical glucocorticoid, prednisolone, during hospitalization from 2008 to 2014 from an MID of Hamamatsu University Hospital in Japan...
January 18, 2017: Journal of Clinical Pharmacy and Therapeutics
https://www.readbyqxmd.com/read/28073851/increased-risk-of-adverse-neurocognitive-outcomes-with-proprotein-convertase-subtilisin-kexin-type-9-inhibitors
#18
Abdur Rahman Khan, Chirag Bavishi, Haris Riaz, Talha A Farid, Sobia Khan, Michel Atlas, Glenn Hirsch, Sohail Ikram, Roberto Bolli
BACKGROUND: There is encouraging evidence of the efficacy of proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors; however, their long-term safety remains unclear. We performed a meta-analysis of studies to evaluate the long-term safety of PCSK9 inhibitors. METHODS AND RESULTS: Our search strategy yielded 11 studies (9 smaller early-phase and 2 larger outcome trials). The outcomes assessed were cumulative serious adverse events, musculoskeletal adverse events, neurocognitive adverse events, and stroke...
January 2017: Circulation. Cardiovascular Quality and Outcomes
https://www.readbyqxmd.com/read/28073687/adverse-event-detection-using-the-fda-post-marketing-drug-safety-surveillance-system-cardiotoxicity-associated-with-loperamide-abuse-and-misuse
#19
Kimberley A Swank, Eileen Wu, Cindy Kortepeter, Jana McAninch, Robert L Levin
OBJECTIVE: The purpose of this investigation was to identify and characterize post-marketing reports of cardiotoxicity, including torsades de pointes (TdP), associated with loperamide use. METHODS: We searched the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database for post-marketing reports of serious cardiac adverse events associated with loperamide use from December 28, 1976 (U.S. drug approval date), through December 14, 2015. We also conducted a Pubmed and Google Scholar search to identify additional published reports of cardiotoxicity associated with loperamide in the medical literature through February 11, 2016...
January 7, 2017: Journal of the American Pharmacists Association: JAPhA
https://www.readbyqxmd.com/read/28060547/the-safety-of-sacubitril-valsartan-for-the-treatment-of-chronic-heart-failure
#20
Jeffrey M Tyler, John R Teerlink
Sacubitril-valsartan is a combination drug that contains the neprilysin inhibitor sacubitril and angiotensin II receptor blocker valsartan. In 2015, the US Food and Drug Administration approved sacubitril-valsartan for treatment of heart failure patients with reduced ejection fraction and New York Heart Association class II-IV symptoms following a large, Phase III clinical trial (PARADIGM-HF) that demonstrated a 20% reduction in the combined primary end-point of death from cardiovascular cause or hospitalization for heart failure compared to enalapril...
January 6, 2017: Expert Opinion on Drug Safety
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