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Adverse drug reactions

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https://www.readbyqxmd.com/read/28087644/u-s-fda-approval-summary-nivolumab-for-treatment-of-unresectable-or-metastatic-melanoma-following-progression-on-ipilimumab
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
https://www.readbyqxmd.com/read/28070717/identification-of-new-synthetic-cannabinoid-adb-chminaca-mab-chminaca-metabolites-in-human-hepatocytes
#10
Jeremy Carlier, Xingxing Diao, Cristina Sempio, Marilyn A Huestis
ADB-CHMINACA (MAB-CHMINACA) is a new synthetic cannabinoid with high potency and many reported adverse events and fatalities. The drug is currently scheduled in several countries in Europe and the USA. Analytical methods need to be developed to confirm ADB-CHMINACA intake for clinical and forensic programs. For many synthetic cannabinoids, parent compound is not detectable in biological samples after intake, making the detection of metabolites the only way to prove consumption. Therefore, detection of ADB-CHMINACA metabolites in biological specimens is critical...
January 9, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28070469/leukocytoclastic-vasculitis-with-systemic-involvement-associated-with-ciprofloxacin-therapy-case-report-and-review-of-the-literature
#11
REVIEW
Bruno Morgado, Catarina Madeira, Joana Pinto, Joana Pestana
A 71-year-old woman presented with constitutional signs and lower extremity palpable purpura after being prescribed a four-day course of 500 mg of ciprofloxacin two times daily for a gastrointestinal infection. She was admitted for inpatient treatment. During the third hospital day, she presented with an episode of abundant hematemesis while her skin lesions remained unchanged. Upper endoscopy revealed multiple lesions consistent with vasculitis and histological examination of the skin biopsy disclosed a leukocytoclastic vasculitis...
November 28, 2016: Curēus
https://www.readbyqxmd.com/read/28066878/safety-and-effectiveness-of-sodium-stibogluconate-and-paromomycin-combination-for-the-treatment-of-visceral-leishmaniasis-in-eastern-africa-results-from-a-pharmacovigilance-programme
#12
Robert Kimutai, Ahmed M Musa, Simon Njoroge, Raymond Omollo, Fabiana Alves, Asrat Hailu, Eltahir A G Khalil, Ermias Diro, Peninah Soipei, Brima Musa, Khalid Salman, Koert Ritmeijer, Francois Chappuis, Juma Rashid, Rezika Mohammed, Asfaw Jameneh, Eyasu Makonnen, Joseph Olobo, Lawrence Okello, Patrick Sagaki, Nathalie Strub, Sally Ellis, Jorge Alvar, Manica Balasegaram, Emilie Alirol, Monique Wasunna
INTRODUCTION: In 2010, WHO recommended a new first-line treatment for visceral leishmaniasis (VL) in Eastern Africa. The new treatment, a combination of intravenous (IV) or intramuscular (IM) sodium stibogluconate (SSG) and IM paromomycin (PM) was an improvement over SSG monotherapy, the previous first-line VL treatment in the region. To monitor the new treatment's safety and effectiveness in routine clinical practice a pharmacovigilance (PV) programme was developed. METHODS: A prospective PV cohort was developed...
January 9, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28066110/assessment-of-impact-of-pharmacophilia-and-pharmacophobia-on-medication-adherence-in-patients-with-psychiatric-disorders-a-cross-sectional-study
#13
Mini Johnson Christudas, Balaji Sathyanarayana Gupta, Krishna Undela, Noel M Isaac, Dushad Ram, Madhan Ramesh
AIMS: To investigate the impact of pharmacophilia and pharmacophobia on medication adherence among patients with psychiatric disorders. MATERIALS AND METHODS: A cross-sectional, observational study was conducted in the Department of Psychiatry over a period of 2 months. Patients above 18 years of age with a psychiatric diagnosis as per the International Classification of Diseases 10 and receiving at least one psychotropic medication (any medication capable of affecting the mind, emotions, and behavior) for >1 month were enrolled in the study...
November 2016: Indian Journal of Pharmacology
https://www.readbyqxmd.com/read/28066102/randomized-double-blind-comparative-study-of-oral-metronidazole-and-tinidazole-in-treatment-of-bacterial-vaginosis
#14
Indu M Raja, Asha Basavareddy, Deepali Mukherjee, Bikash Ranjan Meher
OBJECTIVE: To compare the efficacy and tolerability of oral metronidazole and tinidazole in patients with bacterial vaginosis (BV) using Amsel's criteria. PATIENTS AND METHODS: This was a randomized double-blind study, conducted by the Departments of Pharmacology and Gynecology of a tertiary care teaching hospital. Patients diagnosed with BV received either tablet metronidazole 500 mg twice daily for 5 days or tablet tinidazole 500 mg once daily + one placebo for 5 days and instructed to come for follow-up at the 1(st) week and 4(th) week...
November 2016: Indian Journal of Pharmacology
https://www.readbyqxmd.com/read/28066097/pharmacovigilance-programme-of-india-recent-developments-and-future-perspectives
#15
Vivekanandan Kalaiselvan, Prasad Thota, Gyanendra Nath Singh
Promoting safe use of medicines is a priority of Indian Pharmacopoeia Commission that functions as the National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI). One hundred and seventy-nine adverse drug reactions (ADRs) monitoring centers currently report ADRs to NCC. Current India contribution to global safety database reaches 3% and the completeness score is 0.93 out of 1. NCC is taking several measures to enhance patient safety including capacity building for monitoring, surveillance, collaboration with national health programs and other organizations to increase ADR reporting and to ensure that PvPI is a vital knowledge database for Indian regulators...
November 2016: Indian Journal of Pharmacology
https://www.readbyqxmd.com/read/28065444/investigating-patient-narratives-posted-on-internet-and-their-informativeness-level-for-pharmacovigilance-purpose-the-example-of-comments-about-statins
#16
Farid Kheloufi, Anne Default, Olivier Blin, Joelle Micallef
AIM OF THE STUDY: Health-related networks like patient health forums may be considered as potential sources of information to early detect pharmacovigilance issues or complete data on drug safety. However, the clinical and pharmacological relevancy of such a source has not been clearly explored. We aimed to describe the characteristics and the informativeness level of Internet narratives posted by patients and mentioning adverse drug reactions (ADRs) related to statins. METHODS: A retrospective cross-sectional study was conducted on an Internet website dedicated to share experience on medicines...
December 9, 2016: Thérapie
https://www.readbyqxmd.com/read/28065233/optimal-treatment-strategies-of-clozapine-for-refractory-schizophrenia
#17
Yuan-Yuan Li, Yun-Shu Zhang, Jian Wang, Ke-Qing Li, Hong-Ying Wang
Objective To systematically evaluate the efficacy of clozapine combined with other antipsychotic drugs in the treatment of refractory schizophrenia. Methods We searched Medline, EMBASE, and China Biology Medicine databases in both English and Chinese for randomized controlled trials, quasi-randomization controlled trials, and clinical controlled trials concerning the combinations of clozapine with other antipsychotic drugs for refractory schizophrenia. Quality assessment and data extraction were conducted with the Cochrane collaboration's RevMan 5...
December 20, 2016: Zhongguo Yi Xue Ke Xue Yuan Xue Bao. Acta Academiae Medicinae Sinicae
https://www.readbyqxmd.com/read/28064419/pharmacokinetics-and-pharmacogenetics-of-carbamazepine-in-children
#18
Natasa Djordjevic, Slobodan M Jankovic, Jasmina R Milovanovic
Although carbamazepine is one of the oldest anticonvulsant drugs, it is still heavily utilized for treatment of epilepsy in children. The aim of this article was to review the current knowledge about pharmacokinetics and pharmacogenetics of carbamazepine in children. The literature for this review was systematically searched for in the MEDLINE and SCINDEKS databases. Oral bioavailability of carbamazepine in children is about 75-85%, and it is approximately 75-85% bound to plasma proteins. Apparent volume of distribution is 1...
January 7, 2017: European Journal of Drug Metabolism and Pharmacokinetics
https://www.readbyqxmd.com/read/28064233/clozapine-associated-with-autoimmune-reaction-fever-and-low-level-cardiotoxicity-a-case-report
#19
Charilaos Gerasimou, Georgia Phaedra Vitali, George D Vavougios, Charalabos Papageorgiou, Athanasios Douzenis, Styliani I Kokoris, Ioannis Liappas, Emmanouil Rizos
BACKGROUND: Clozapine is a second-generation antipsychotic drug used in treatment-resistant schizophrenia. Fever induced by clozapine is a rather frequent side-effect which usually occurs in the first 4 weeks of treatment. Despite its effectiveness, there are potentially life-threatening adverse effects, such as cardiotoxicity. CASE REPORT: We present the case of a 31-year-old caucasian male with refractory schizophrenia who developed benign fever, increase of C-reactive protein and high troponin levels, without presenting any other signs to myocarditis, on the 13th day under clozapine treatment, which declined progressively upon discontinuation of the drug...
January 2017: In Vivo
https://www.readbyqxmd.com/read/28063660/deprescribing-a-narrative-review-of-the-evidence-and-practical-recommendations-for-recognizing-opportunities-and-taking-action
#20
REVIEW
Emily Reeve, Wade Thompson, Barbara Farrell
Deprescribing can be defined as the process of withdrawal or dose reduction of medications which are considered inappropriate in an individual. The aim of this narrative review is to provide an overview of "deprescribing"; firstly discussing the potential benefits and harms followed by the barriers to and enablers of deprescribing. We also provide practical recommendations to recognise opportunities and strategies for deprescribing in practice. Studies focused on minimizing polypharmacy indicate that deprescribing may be associated with potential benefits including resolution of adverse drug reactions, improved quality of life and medication adherence and a reduction in drug costs...
January 4, 2017: European Journal of Internal Medicine
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