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https://www.readbyqxmd.com/read/28096661/patient-knowledge-on-reporting-adverse-drug-reactions-in-poland
#1
Anna Staniszewska, Marta Dąbrowska-Bender, Dominik Olejniczak, Aneta Duda-Zalewska, Magdalena Bujalska-Zadrożny
AIM: The aim of the study was to assess patient knowledge on reporting of adverse drug reactions. MATERIALS AND METHODS: A prospective study was conducted among 200 patients. The study was based on an original survey composed of 15 single- and multiple-choice questions. The study involved individuals who have experienced adverse reactions as well as individuals who have never experienced any adverse reactions; people over the age of 18; literate; residing in Mazowieckie Voivodeship, who have not been diagnosed with any disease that could compromise their logical thinking skills...
2017: Patient Preference and Adherence
https://www.readbyqxmd.com/read/28094583/signal-detection-activity-on-eudravigilance-data-analysis-of-the-procedure-and-findings-from-an-italian-regional-centre-for-pharmacovigilance
#2
Luca Monaco, Mauro Melis, Chiara Biagi, Monia Donati, Ester Sapigni, Alberto Vaccheri, Domenico Motola
BACKGROUND: In July 2012 a new European legislation (Directive 2010/84/EU and Regulation No. 1235/2010) regarding pharmacovigilance has become effective. It has boosted the activity of Signal Detection through a monthly analysis of potential safety signals on EudraVigilance (EV). Our aim is to describe the procedure of signal detection on EV data and to present results obtained by the our pharmacovigilance centre. METHOD: Data are extracted from EV database, which collects suspected Adverse Drug Reactions (ADRs) of medicinal products in Europe...
January 17, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28093797/adverse-reactions-to-dietary-supplements-containing-red-yeast-rice-assessment-of-cases-from-the-italian-surveillance-system
#3
G Mazzanti, P A Moro, E Raschi, R Da Cas, F Menniti-Ippolito
BACKGROUND AND AIM: Red yeast rice (RYR) is contained in dietary supplements used in patients with dyslipidemia. RYR supplements contain monacolin K, which is chemically identical to lovastatin, a licensed drug with a well-known risk profile. We aimed to describe the safety profile of RYR by analysing spontaneous reports of suspected adverse reactions (ARs). METHODS: Within the Italian Surveillance System of Natural Health Products, suspected ARs were collected and evaluated by a multidisciplinary group of experts to assess causality using the WHO-UMC system or the CIOMS/RUCAM score, for hepatic reactions...
January 17, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28093773/establishment-of-a-cell-line-for-assessing-drugs-as-canine-p-glycoprotein-substrates-proof-of-principle
#4
K L Mealey, S Dassanayake, N S Burke
P-glycoprotein (P-gp), encoded by the ABCB1 (MDR1) gene, dramatically impacts drug disposition. P-gp is expressed in the intestines, biliary canaliculi, renal tubules, and brain capillaries where it functions to efflux substrate drugs. In this capacity, P-gp restricts oral absorption, enhances biliary and renal excretion, and inhibits central nervous system entry of substrate drugs. Many drugs commonly used in veterinary medicine are known substrates for canine P-gp (vincristine, loperamide, ivermectin, others)...
January 17, 2017: Journal of Veterinary Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28092143/human-leucocyte-antigen-adverse-drug-reaction-associations-from-a-perspective-of-ethnicity
#5
REVIEW
G S Ghattaoraya, D Middleton, E J M Santos, R Dickson, A R Jones, A Alfirevic
Whilst immune-mediated adverse drug reactions (ADRs) are rare, they are potentially life-threatening and present a major problem for clinicians. The underlying mechanisms that cause ADRs are not fully understood although genomewide association studies (GWAS) and case-control investigations have associated human leucocyte antigen (HLA) alleles as risk factors. There is evidence that a patient's ethnic background can have an impact on their risk of developing an ADR. This review summarizes the evidence related to HLA alleles and ADRs with particular focus on patient ethnicity...
February 2017: International Journal of Immunogenetics
https://www.readbyqxmd.com/read/28090715/health-care-professionals-knowledge-and-perception-of-pharmacovigilance-in-a-tertiary-care-teaching-hospital-in-amman-jordan
#6
Khawla Abu Hammour, Faris El-Dahiyat, Rana Abu Farha
RATIONALE, AIMS, AND OBJECTIVES: Underreporting of adverse drug reactions (ADRs) by health care professionals is a common inherent health problem encountered in many countries. This could be explained by the lack of awareness and knowledge about the guidelines to follow to identify and report ADRs. Thus, this study aimed to evaluate the awareness, knowledge, and perceptions among medical doctors and nurses regarding their role as ADRs reporters in Jordan. METHODS: A cross-sectional study was conducted between September 2015 to January 2016 at the Jordan University Hospital in Amman...
January 16, 2017: Journal of Evaluation in Clinical Practice
https://www.readbyqxmd.com/read/28090515/a-systematic-review-of-combinatorial-treatment-with-warming-and-invigorating-drugs-and-levothyroxine-for-hypothyroidism-caused-by-hashimoto-disease
#7
Xiangwen Cheng, Zixiao Wei, Guangde Zhang, Xin Shao, Bo Li, Rui Gao
BACKGROUND: We used the systematic review method to evaluate the clinical efficacy and safety of combinatorial treatment with warming and invigorating drugs and levothyroxine on hypothyroidism caused by Hashimoto thyroiditis (HT). METHODS: We set inclusion and exclusion criteria, searched for studies using electronic databases and manual retrieval, selected studies according to the inclusion and exclusion criteria, and assessed the qualities of the included studies according to the Jadad scale...
December 2016: Annals of Translational Medicine
https://www.readbyqxmd.com/read/28090460/efficacy-and-safety-of-dienogest-in-patients-with-endometriosis-a-single-center-observational-study-over-12-months
#8
So Yun Park, Sung Hoon Kim, Hee Dong Chae, Chung-Hoon Kim, Byung Moon Kang
OBJECTIVE: To evaluate the efficacy and safety of dienogest treatment in patients who had received dienogest for 12 months or more to treat endometriosis. METHODS: We analyzed the clinical data of 188 women with endometriosis who had been treated with 2 mg of dienogest once a day for 12 months or more at a single institute. We evaluated changes in endometriosis-associated pain and endometrioma size, recurrence rate, and adverse events following dienogest administration...
December 2016: Clinical and Experimental Reproductive Medicine
https://www.readbyqxmd.com/read/28090068/relationship-between-physicochemical-properties-of-medical-supplies-and-serious-adverse-drug-reactions-listed-in-the-package-inserts
#9
Reiko Yano, Fumiko Ohtsu, Nobuyuki Goto
<bibitem lang="en">  We sought to clarify the relationship between the physicochemical properties of each medical supply and serious adverse drug reactions listed in the package inserts, by reviewing new information. We investigated 1) 1,078 medicines currently available on the domestic Japanese market by using physicochemical data, such as cLogD, molecular weight (MW), and pKa and 2) the serious adverse drug reactions stated in the package inserts and the presence or absence of serious renal and liver disorders, as well as mental, extrapyramidal, and skin disorders...
January 13, 2017: Yakugaku Zasshi: Journal of the Pharmaceutical Society of Japan
https://www.readbyqxmd.com/read/28089608/piloting-the-united-kingdom-prescribing-safety-assessment-with-pharmacist-prescribers-in-scotland
#10
Fiona Reid, Ailsa Power, Derek Stewart, Anne Watson, Leon Zlotos, Derna Campbell, Trudi McIntosh, Simon Maxwell
BACKGROUND: Prescribing is a complex task requiring considerable knowledge and skills. The Prescribing Safety Assessment (PSA) was developed by the British Pharmacological Society and the United Kingdom (UK) Medical Schools Council. Between February and June 2014, over 7000 final year medical students undertook the PSA, with an overall pass rate of 94%. Independent prescribing for suitably trained pharmacists was introduced in the UK in 2006. To date there has been little focus on any objective measures of prescribing safety...
January 6, 2017: Research in Social & Administrative Pharmacy: RSAP
https://www.readbyqxmd.com/read/28088792/impact-of-nudt15-polymorphisms-on-thiopurines-induced-myelotoxicity-and-thiopurines-tolerance-dose
#11
Dandan Yin, Xuyang Xia, Junlong Zhang, Shouyue Zhang, Fei Liao, Ge Zhang, Yan Zhang, Qianqian Hou, Xue Yang, Hong Wang, Zhigui Ma, Heyao Wang, Yiping Zhu, Wei Zhang, Yuelan Wang, Bo Liu, Lanlan Wang, Heng Xu, Yang Shu
Thiopurines are widely used as anticancer and immunosuppressive agents. However, life-threatening myelotoxicity has been noticed and largely explained by genetic variations, including NUDT15 polymorphisms (e.g., rs116855232). In this study, we conduct a meta-analysis to investigate the impact of rs116855232 on thiopurines-induced myelotoxicity susceptibility (1752 patients from 7 independent cohorts), as well as on thiopurines intolerance dose (2745 patients from 13 cohorts). Variant allele of rs116855232 contributes 7...
January 11, 2017: Oncotarget
https://www.readbyqxmd.com/read/28087644/u-s-fda-approval-summary-nivolumab-for-treatment-of-unresectable-or-metastatic-melanoma-following-progression-on-ipilimumab
#12
Maitreyee Hazarika, Meredith K Chuk, Marc R Theoret, Sirisha Mushti, Kun He, Shawna L Weis, Alexander H Putman, Whitney S Helms, Xianhua Cao, Hongshan Li, Hong Zhao, Liang Zhao, Joel Welch, Laurie Graham, Meredith Libeg, Rajeshwari Sridhara, Patricia Keegan, Richard Pazdur
On December 22, 2014, the U. S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (OPDIVO®, Bristol-Myers Squibb) for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation-positive, a BRAF inhibitor. Approval was based on a clinically meaningful, durable objective response rate (ORR) in a non-comparative analysis of 120 patients who received nivolumab 3 mg/kg intravenously every 2 weeks with at least 6 months follow-up in an ongoing, randomized, open-label, active-controlled clinical trial...
January 13, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28087585/standard-based-comprehensive-detection-of-adverse-drug-reaction-signals-from-nursing-statements-and-laboratory-results-in-electronic-health-records
#13
Suehyun Lee, Jiyeob Choi, Hun-Sung Kim, Grace Juyun Kim, Kye Hwa Lee, Chan Hee Park, Jongsoo Han, Dukyong Yoon, Man Young Park, Rae Woong Park, Hye-Ryun Kang, Ju Han Kim
OBJECTIVE: We propose 2 Medical Dictionary for Regulatory Activities-enabled pharmacovigilance algorithms, MetaLAB and MetaNurse, powered by a per-year meta-analysis technique and improved subject sampling strategy. MATRIALS AND METHODS: This study developed 2 novel algorithms, MetaLAB for laboratory abnormalities and MetaNurse for standard nursing statements, as significantly improved versions of our previous electronic health record (EHR)-based pharmacovigilance method, called CLEAR...
January 13, 2017: Journal of the American Medical Informatics Association: JAMIA
https://www.readbyqxmd.com/read/28079787/oral-and-vulvo-vaginal-lichenoid-reactions-due-to-mitotane-lysodren-a-case-report
#14
Arthur Schmouchkovitch, Héloïse Herry, Philippe Thuillier, Véronique Kerlan, Camille Fleuret, Guy Le Toux, Sylvie Boisramé
BACKGROUND: The purpose of pharmacovigilance (drug safety) is collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. It is meant to identify, characterize, prevent, or minimize actual or potential risks relating to medicinal products. To prevent these adverse effects and improve our practice, health professionals have a duty to report side effects to assess this risk and evaluate the benefit/risk requirements. Mitotane (Lysodren) is used for treating adrenocortical carcinoma...
January 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28073844/fda-approval-of-nivolumab-for-the-first-line-treatment-of-patients-with-brafv600-wild-type-unresectable-or-metastatic-melanoma
#15
Julia A Beaver, Marc R Theoret, Sirisha Mushti, Kun He, Meredith Libeg, Kirsten Goldberg, Rajeshwari Sridhara, Amy E McKee, Patricia Keegan, Richard Pazdur
On November 23, 2015, the U.S. Food and Drug Administration approved nivolumab (OPDIVO®, Bristol Myers Squibb, Co.) as a single agent for the first-line treatment of patients with BRAFV600 wild-type, unresectable or metastatic melanoma. An international, double-blind, randomized (1:1) trial conducted outside of the U.S. allocated 418 patients to receive nivolumab 3mg/kg intravenously every 2 weeks (n=210) or dacarbazine 1000mg/m2 intravenously every 3 weeks (n=208). Patients with disease progression who met protocol-specified criteria (~25% of each trial arm) were permitted to continue with the assigned treatment in a blinded fashion until further disease progression is documented...
January 10, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28073793/adverse-drug-reactions-to-anticoagulants-in-spain-analysis-of-the-spanish-national-hospital-discharge-data-2010-2013
#16
P Carrasco-Garrido, V Hernández-Barrera, J Esteban-Hernández, I Jiménez-Trujillo, A Álvaro-Meca, A López de Andrés, J de Miguel Diez, J M Rodríguez Barrios, J A Muñoz Robles, R Jiménez-García
OBJECTIVE: To describe and analyse hospitalisations for adverse drug reactions (ADRs) involving anticoagulants. We also analysed the progress of the reactions over time, the factors related with ADRs. DESIGN: A retrospective, descriptive, epidemiological study. SETTING: This study used the Spanish National Hospital Discharge Database (Conjunto Mínimo Básico de Datos, CMBD), over a 4-year period. PARTICIPANTS: We selected CMBD data corresponding to hospital discharges with a diagnosis of ADRs to anticoagulants (International Classification of Diseases-Ninth Revision, Clinical Modification (ICD-9-CM) code E934...
January 10, 2017: BMJ Open
https://www.readbyqxmd.com/read/28072733/efficacy-and-safety-of-puerarin-injection-in-curing-acute-ischemic-stroke-a-meta-analysis-of-randomized-controlled-trials
#17
Qing-Hua Zheng, Xiao-Li Li, Zhi-Gang Mei, Li Xiong, Qing-Xian Mei, Jin-Feng Wang, Ling-Jing Tan, Song-Bai Yang, Zhi-Tao Feng
BACKGROUND: Previous studies indicated that the puerarin injection has been widely employed in China for the treatment of acute ischemic stroke. We aim to evaluate the efficacy and safety of the puerarin injection for the treatment of acute ischemic stroke. METHODS: A systematic literature search was performed in PUBMED, EMBASE, SPRINGER LINK, Scopus, Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP Journals Database, Wanfang database and the China Biological Medicine database before November 2016, randomized controlled clinical trials (RCTs) of puerarin injection treating acute ischemic stroke were included...
January 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28071845/influence-of-age-sex-and-seriousness-on-reporting-of-adverse-drug-reactions-in-sweden
#18
Lennart Holm, Elisabet Ekman, Kerstin Jorsäter Blomgren
PURPOSE: To investigate how reporting of adverse drug reactions (ADRs) among adults in Sweden is associated to age and sex, in addition to seriousness of the reaction and drug utilisation. METHODS: Individual case safety reports (ICSRs) reported by healthcare professionals to the national pharmacovigilance database 2008-2011 were related to defined daily dose (DDD) in the Swedish Prescribed Drug Register (SPDR) for individual's ≥20 years. Data were stratified into five age groups...
January 10, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28071818/safety-profile-of-the-direct-oral-anticoagulants-an-analysis-of-the-who-database-of-adverse-drug-reactions
#19
Luca Monaco, Chiara Biagi, Valentino Conti, Mauro Melis, Monia Donati, Mauro Venegoni, Alberto Vaccheri, Domenico Motola
AIM: Direct oral anticoagulants (DOACs) have shown non-inferiority to warfarin for stroke prevention in non-valvular atrial fibrillation (AF) and a more promising safety profile. Unanswered safety aspects remain to addressed and available evidence on the risk associated with these drugs are conflicting. In order to contribute to the debate on their safety profile, we conducted a comparative analysis of the reports of suspected adverse drug reactions (ADRs) associated with DOACs in VigiBase...
January 10, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28070824/tolerability-of-an-immunologically-enhanced-subcutaneous-immunotherapy-preparation-in-patients-treated-with-concomitant-allergy-immunotherapy-a-non-interventional-observational-study
#20
Rainer Reiber, Hendrik Wolf, Jörg Schnitker, Eike Wüstenberg
BACKGROUND: For causal treatment by allergy immunotherapy (AIT) a single or few allergen products for the clinically most relevant allergens are applied to treat multiple allergies, but few data on the tolerability of multiple AIT applications are available. OBJECTIVE: The aim of our study was to investigate safety and tolerability in patients treated by subcutaneous immunotherapy (SCIT) and concomitant SCIT or sublingual immunotherapy (SLIT) products. METHODS: In a non-interventional, observational study in Germany treatment of patients with a primary SCIT and concomitant AIT (SCIT or SLIT) was documented during the first 4 months of treatment...
January 9, 2017: Drugs—Real World Outcomes
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