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https://www.readbyqxmd.com/read/28646580/biosimilars-for-psoriasis-worldwide-overview-of-regulatory-guidelines-uptake-and-implications-for-dermatology-clinical-practice
#1
REVIEW
A D Cohen, J J Wu, L Puig, S Chimenti, R Vender, M Rajagopalan, R Romiti, C de la Cruz, L Skov, C Zachariae, H S Young, P Foley, J M van der Walt, L Naldi, A Blauvelt
The introduction of biologic drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologic drugs for patients with psoriasis...
June 24, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28641055/long-term-safety-evaluation-of-natalizumab-for-the-treatment-of-multiple-sclerosis
#2
Marinella Clerico, Carlo Alberto Artusi, Alessandra Di Liberto, Simona Rolla, Valentina Bardina, Pierangelo Barbero, Stefania Federica De Mercanti, Luca Durelli
Introduction Natalizumab is a humanized monoclonal antibody highly effective in relapsing-remitting multiple sclerosis (MS). Important concerns about its safety have been pointed out because of the risk of progressive multifocal leukoencephalopathy (PML), caused by the opportunistic John-Cunningham virus (JCV). Areas covered This review analyzes all the safety aspects related to the use of natalizumab in MS patients. Fatigue and allergic reactions are not-severe adverse events (AEs) occurring more frequently than placebo and no differences in serious AEs (SAE) have been observed comparing to interferon-β1a during clinical trials...
June 22, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28632830/-declaration-of-the-chilean-academy-of-medicine-of-law-20-850-on-clinical-trials-of-pharmaceutical-products-and-medical-devices-and-of-the-bylaw-that-will-regulate-its-application
#3
Gloría López, Gloría Valdés, Emilio Roessler, Vicente Valdivieso
In Chile, high cost treatments required by selected medical conditions are financed by the State, according to Law 20.850. A bylaw under discussion by the Senate regulates clinical trials, posing complex issues that will endanger local interest in front-line research: 1) The exclusive and mandatory control bestowed to the Institute of Public Health during all stages of the trials and also the surveillance of institutions performing clinical trials, overriding their Clinical Research Review Boards; 2) The 10 year period during which any adverse event is assumed to have been caused by the medication or devise evaluated by the trial, unless the contrary is proven in a judicial process; 3) Individuals submitted to the trials are entitled to free post trial access to the treatment received during the study, financed by the trial supporting entities and as long as the drug or devise is considered to be useful...
April 2017: Revista Chilena de Infectología: órgano Oficial de la Sociedad Chilena de Infectología
https://www.readbyqxmd.com/read/28627937/the-safety-of-intra-articular-injections-for-the-treatment-of-knee-osteoarthritis-a-critical-narrative-review
#4
Christelle Nguyen, François Rannou
International guidelines recommend that the management of knee osteoarthritis (OA) combine both nonpharmacological and pharmacological interventions. Intra-articular (IA) therapies are considered part of this multimodal approach and are well-established Food and Drug Administration (FDA) and European Medicines Agency (EMA)-approved treatments. Areas covered. Safety data for knee OA, including IA corticosteroids, hyaluronic acid, platelet-rich plasma and botulinum toxin are critically reviewed, and evidence- and pratice-based measures to improve safety of IA therapies are discussed...
June 19, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28582563/participant-centred-active-surveillance-of-adverse-events-following-immunisation-a-narrative-review
#5
Patrick Cashman, Kristine Macartney, Gulam Khandaker, Catherine King, Michael Gold, David N Durrheim
The importance of active, participant-centred monitoring of adverse events following immunisation (AEFI) is increasingly recognised as a valuable adjunct to traditional passive AEFI surveillance. The databases OVID Medline and OVID Embase were searched to identify all published articles referring to AEFI. Only studies which sought participant response after vaccination were included. A total of 6060 articles published since the year 2000 were identified. After the application of screening inclusion and exclusion criteria, 25 articles describing 23 post-marketing AEFI systems were identified...
May 1, 2017: International Health
https://www.readbyqxmd.com/read/28580889/phosphodiesterase-5-inhibitors-and-their-analogues-as-adulterants-of-herbal-and-food-products-analysis-of-the-malaysian-market-in-2014-2016
#6
Nur Baizura Bujang, Chin Fei Chee, Choon Han Heh, Noorsaadah Abd Rahman, Michael J C Buckle
Adulteration of herbal health supplements with phosphodiesterase-5 (PDE-5) inhibitors and their analogues is becoming a worldwide problem. The aim of this study was to investigate herbal and food products sold in the Malaysian market for the presence of these adulterants. Sixty-two products that claim to enhance men's sexual health were sampled between April 2014 and April 2016. These products included unregistered products seized by the Pharmacy Enforcement Division of the Ministry of Health (n = 39), products sent to the National Pharmaceutical Regulatory Agency for pre-registration testing (n = 9) and products investigated under the post-registration market surveillance programme (n = 14)...
June 5, 2017: Food Additives & Contaminants. Part A, Chemistry, Analysis, Control, Exposure & Risk Assessment
https://www.readbyqxmd.com/read/28571476/the-safety-and-tolerability-of-nintedanib-in-the-treatment-of-idiopathic-pulmonary-fibrosis
#7
Vincent Cottin
Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease that primarily affects older individuals. Nintedanib, a tyrosine kinase inhibitor, has been approved for the treatment of IPF in several countries. The safety and tolerability of nintedanib have been investigated in clinical trials and in real-world studies (compassionate use programs and post-marketing surveillance). Areas covered: Most frequent adverse events reported in patients treated with nintedanib (gastrointestinal); additional adverse events of special interest (elevations in liver enzymes, bleeding, cardiovascular adverse events); recommendations for managing adverse events...
June 15, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28552510/post-marketing-safety-surveillance-for-inactivated-and-live-attenuated-japanese-encephalitis-vaccines-in-china-2008-2013
#8
Wendi Wu, Dawei Liu, Keli Li, J Pekka Nuorti, Hanna M Nohynek, Disha Xu, Jiakai Ye, Jingshan Zheng, Huaqing Wang
INTRODUCTION: Two types of Japanese encephalitis (JE) vaccines, inactivated JE vaccine (JE-I) and live-attenuated JE vaccine (JE-L), are available and used in China. In particular, one JE-L, produced by a domestic manufacturer in China, was prequalified by WHO in 2013. We assessed the safety of JE vaccines in China during 2008-2013 using the Chinese National Adverse Events Following Immunization Information System (CNAEFIS) data. METHODS: We retrieved AEFI reporting data about JE vaccines from CNAEFIS, 2008-2013, examined demographic characteristics of AEFI cases, and used administrative data on vaccine doses as denominator to calculate and compare crude reporting rates...
June 22, 2017: Vaccine
https://www.readbyqxmd.com/read/28548196/-declaration-of-the-chilean-academy-of-medicine-of-law-20-850-%C3%A2-on-clinical-trials-of-pharmaceutical-products-and-medical-devices%C3%A2-and-of-the-bylaw-that-will-regulate-its-application
#9
Gloria López S, Gloria Valdés S, Emilio Roessler B, Vicente Valdivieso D
In Chile, high cost treatments required by selected medical conditions are financed by the State, according to Law 20.850. A bylaw under discussion by the Senate regulates clinical trials, posing complex issues that will endanger local interest in front-line research: 1. The exclusive and mandatory control bestowed to the Institute of Public Health during all stages of the trials and also the surveillance of institutions performing clinical trials, overriding their Clinical Research Review Boards; 2.The 10 year period during which any adverse event is assumed to have been caused by the medication or devise evaluated by the trial, unless the contrary is proven in a judicial process; 3...
March 2017: Revista Médica de Chile
https://www.readbyqxmd.com/read/28532461/national-post-market-surveillance-assessment-of-veterinary-medicines-in-korea-during-the-past-decade
#10
JeongWoo Kang, Hae-Chul Park, Yang Ho Jang, Md Akil Hossain, Kyunghun Jeong, Mi Young Jeong, Seon-Jong Yun, Sung-Won Park, Dae Gyun Kim, Kwang-Jick Lee
BACKGROUND: Veterinary medicines have been widely used for the prevention and treatment of diseases, growth promotion, and to promote feeding efficacy in livestock. As the veterinary medicine industry has steadily grown, it is crucial to set up a baseline for the quality of medicine as well as the insufficiency or excessiveness of the active ingredients in drug products to ensure the compliance, safety and efficacy of these medicines. Thus, the 10 years data of post-marketing quality control study was summarized to determine the rate and extent of non-compliance of these medicines and to establish baseline data for future quality control measures of veterinary medicine...
May 22, 2017: BMC Veterinary Research
https://www.readbyqxmd.com/read/28510606/safety-and-efficacy-of-cell-free-and-concentrated-ascites-reinfusion-therapy-cart-in-refractory-ascites-post-marketing-surveillance-results
#11
Norio Hanafusa, Ayako Isoai, Tomoaki Ishihara, Tetsuya Inoue, Ken Ishitani, Taiju Utsugisawa, Toshihiko Yamaka, Tetsuya Ito, Hiroshi Sugiyama, Atsushi Arakawa, Yosuke Yamada, Yasuo Itano, Hirokazu Onodera, Ryosuke Kobayashi, Naoko Torii, Toyoko Numata, Taihei Kashiwabara, Yoshihiro Matsuno, Michio Kato
We performed post-marketing surveillance to evaluate the safety and efficacy of cell-free and concentrated ascites reinfusion therapy (CART). In total, 356 CART sessions in 147 patients at 22 centers were performed. The most common primary disease was cancer (128 cases, 300 sessions). Mean amount of ascites collected was 3.7 L, and mean concentration ratio was 9.2. Mean amount of reinfused protein was 67.8 g (recovery rate, 72.0%). Performance status, dietary intake, urine volume, body weight and abdominal circumference were significantly improved after CART...
2017: PloS One
https://www.readbyqxmd.com/read/28490974/the-introduction-of-biosimilars-of-low-molecular-weight-heparins-in-europe-a-critical-review-and-reappraisal-endorsed-by-the-italian-society-for-haemostasis-and-thrombosis-siset-and-the-italian-society-for-angiology-and-vascular-medicine-siapav
#12
REVIEW
Davide Imberti, Marco Marietta, Hernan Polo Friz, Claudio Cimminiello
Recently, the European Medicines Agency (EMA) authorized the introduction and marketing of Thorinane® and Inhixa®, biosimilars of the Low Molecular Weight Heparin (LMWH) enoxaparin. The authorization path is considerably different from the guidelines published by the EMA in 2009, as well as from the recommendations from the International Society on Thrombosis and Haemostasis published in 2013. Indeed, both of them recommended that LMWHs biosimilars therapeutic equivalence should be demonstrated in at least one adequately designed clinical trial...
2017: Thrombosis Journal
https://www.readbyqxmd.com/read/28488101/impact-of-chronic-renal-failure-on-safety-and-effectiveness-of-paclitaxel-eluting-stents-for-femoropopliteal-artery-disease-subgroup-analysis-from-zilver-ptx-post-market-surveillance-study-in-japan
#13
Yukihisa Ogawa, 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: Favorable long-term outcomes of the Zilver PTX drug-eluting stent (DES) in femoropopliteal lesions have been demonstrated. Chronic renal failure (CRF) has been shown to be a risk factor for restenosis and decreased limb salvage. The results of the DES in patients with CRF have not previously been reported. This study compares the results with the DES in patients with CRF and those without CRF. METHODS: This retrospective analysis from the Zilver PTX Japan Post-Market Surveillance Study included 321 patients with CRF and 584 patients without CRF...
May 9, 2017: Cardiovascular and Interventional Radiology
https://www.readbyqxmd.com/read/28480041/risk-of-qt-prolongation-and-torsade-de-pointes-associated-with-exposure-to-hydroxyzine-re-evaluation-of-an-established-drug
#14
Anne-Françoise Schlit, Annie Delaunois, Aurore Colomar, Branderley Claudio, Luca Cariolato, Rossen Boev, Jean-Pierre Valentin, Christopher Peters, Victor S Sloan, Jürgen W G Bentz
Several noncardiac drugs have been linked to cardiac safety concerns, highlighting the importance of post-marketing surveillance and continued evaluation of the benefit-risk of long-established drugs. Here, we examine the risk of QT prolongation and/or torsade de pointes (TdP) associated with the use of hydroxyzine, a first generation sedating antihistamine. We have used a combined methodological approach to re-evaluate the cardiac safety profile of hydroxyzine, including: (1) a full review of the sponsor pharmacovigilance safety database to examine real-world data on the risk of QT prolongation and/or TdP associated with hydroxyzine use and (2) nonclinical electrophysiological studies to examine concentration-dependent effects of hydroxyzine on a range of human cardiac ion channels...
June 2017: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/28473520/examining-the-safety-of-menstrual-cups-among-rural-primary-school-girls-in-western-kenya-observational-studies-nested-in-a-randomised-controlled-feasibility-study
#15
Jane Juma, Elizabeth Nyothach, Kayla F Laserson, Clifford Oduor, Lilian Arita, Caroline Ouma, Kelvin Oruko, Jackton Omoto, Linda Mason, Kelly T Alexander, Barry Fields, Clayton Onyango, Penelope A Phillips-Howard
OBJECTIVE: Examine the safety of menstrual cups against sanitary pads and usual practice in Kenyan schoolgirls. DESIGN: Observational studies nested in a cluster randomised controlled feasibility study. SETTING: 30 primary schools in a health and demographic surveillance system in rural western Kenya. PARTICIPANTS: Menstruating primary schoolgirls aged 14-16 years participating in a menstrual feasibility study. INTERVENTIONS: Insertable menstrual cup, monthly sanitary pads or 'usual practice' (controls)...
May 4, 2017: BMJ Open
https://www.readbyqxmd.com/read/28461912/sequelae-of-large-head-metal-on-metal-hip-arthroplasties-current-status-and-future-prospects
#16
REVIEW
Christiaan P van Lingen, Luigi M Zagra, Harmen B Ettema, Cees C Verheyen
Large-head metal-on-metal (MoM) bearings were re-popularised in the late 1990s with the introduction of modern hip resurfacing (HR), followed closely by large metal head total hip arthroplasty (THA). A worldwide increase in the use of MoM hip arthroplasty subsequently saw a sharp decline, due to serious complications.MoM was rapidly adopted in the early 2000s until medical device alerts were issued by government regulatory agencies and national and international organisations, leading to post-marketing surveillance and discontinuation of these implants...
October 2016: EFORT open reviews
https://www.readbyqxmd.com/read/28460126/quality-of-artemisinin-based-antimalarial-drugs-marketed-in-nigeria
#17
Oisaemi Izevbekhai, Babatunde Adeagbo, Adeniyi Olagunju, Oluseye Bolaji
Background: Artemisinin combination therapy is first-line therapy for treatment of malaria, which is one of the most significant public health problems in Nigeria. With the increasing level of use of these drugs coupled with the emergence of resistance, there is a need for regular post-market surveillance. Method: Twenty different brands of artesunate-containing antimalarial drugs and 10 brands of artemether-lumefantrine were multi-sourced in the south western part of Nigeria and were subjected to identification, weight uniformity test, and assay using United State pharmacopoeia and International Pharmacopoeia monographs...
February 1, 2017: Transactions of the Royal Society of Tropical Medicine and Hygiene
https://www.readbyqxmd.com/read/28458553/long-term-effect-of-galantamine-on-cognitive-function-in-patients-with-alzheimer-s-disease-versus-a-simulated-disease-trajectory-an-observational-study-in-the-clinical-setting
#18
Ryoko Nakagawa, Takashi Ohnishi, Hisanori Kobayashi, Toshio Yamaoka, Tsutomu Yajima, Ai Tanimura, Toshiya Kato, Kazutake Yoshizawa
BACKGROUND: Long-term maintenance of cognitive function is an important goal of treatment for Alzheimer's disease (AD), but evidence about the long-term efficacy of cholinesterase inhibitors is sparse. To evaluate the long-term efficacy and safety of galantamine for AD in routine clinical practice, we conducted a 72-week post-marketing surveillance study. The effect of galantamine on cognitive function was estimated in comparison with a simulated disease trajectory. PATIENTS AND METHODS: Patients with mild-to-moderate AD received flexible dosing of galantamine (16-24 mg/day) during this study...
2017: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/28448181/blood-pressure-control-with-cilnidipine-treatment-in-japanese-post-stroke-hypertensive-patients-the-ca-attend-study
#19
Shiro Aoki, Naohisa Hosomi, Tomohisa Nezu, Tsukasa Teshima, Hitoshi Sugii, Shinobu Nagahama, Yoshiki Kurose, Hirofumi Maruyama, Masayasu Matsumoto
Blood pressure control is important in post-stroke hypertensive patients and antihypertensive treatment is recommended for such patients. Ca-channel blockers are recommended as the medications of choice for the treatment of post-stroke patients. Here, we report the results of a large-scale prospective post-marketing surveillance study of post-stroke hypertensive patients (n = 2667, male 60.4%, 69.0 ± 10.9 years) treated with cilnidipine, with regard to blood pressure control and adverse reactions. Cilnidipine treatment caused a decrease in both clinic and home blood pressures 2 months after the beginning of treatment, and the decreased blood pressure was maintained until the end of 12 months' observation...
2017: Clinical and Experimental Hypertension: CHE
https://www.readbyqxmd.com/read/28411001/interstitial-lung-disease-induced-by-fluoxetine-systematic-review-of-literature-and-analysis-of-vigiaccess-eudravigilance-and-a-national-pharmacovigilance-database
#20
REVIEW
Arianna Deidda, Claudia Pisanu, Laura Micheletto, Alberto Bocchetta, Maria Del Zompo, Maria Erminia Stochino
We investigated a pulmonary adverse drug reaction possibly induced by fluoxetine, the Interstitial Lung Disease, by performing a systematic review of published case reports on this subject, a review of the World Health Organization VigiAccess database, of the European EudraVigilance database and of a national Pharmacovigilance database (Italian Pharmacovigilance Network). The research found a total of seven cases linking fluoxetine to Interstitial Lung Disease in the literature. 36 cases of interstitial lung disease related to fluoxetine were retrieved from the VigiAccess database (updated to July 2016), and 36 reports were found in EudraVigilance database (updated to June 2016)...
June 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
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