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https://www.readbyqxmd.com/read/27926986/long-term-safety-of-icatibant-treatment-of-patients-with-angioedema-in-real-world-clinical-practice
#1
Andrea Zanichelli, Marcus Maurer, Werner Aberer, Teresa Caballero, Hilary Longhurst, Laurence Bouillet, Vincent Fabien, Irmgard Andresen
The Icatibant Outcome Survey (IOS) is an observational study monitoring safety and effectiveness of icatibant in the real-world setting. We analyzed safety data from 3025 icatibant-treated attacks in 557 patients (enrolled between July 2009 and February 2015). Icatibant was generally well tolerated. Excluding off-label use and pregnancy, 438 patients (78.6%) did not report adverse events (AEs). The remaining 119 (21.4%) patients reported 341 AEs, primarily gastrointestinal disorders (19.6%). Of these, 43 AEs in 17 patients (3...
December 7, 2016: Allergy
https://www.readbyqxmd.com/read/27926652/hysteroscopic-sterilization-with-essure-summary-of-the-u-s-food-and-drug-administration-actions-and-policy-implications-for-postmarketing-surveillance
#2
Jessica R Walter, Comeron W Ghobadi, Emily Hayman, Shuai Xu
In September 2015, the U.S. Food and Drug Administration (FDA) convened a meeting of the Obstetrics and Gynecology Advisory Board Committee to address the sudden increase of patient-reported adverse events surrounding Essure, a Class III device offering a less invasive method for permanent female sterilization. After a review of the premarketing and postmarketing data and existing scientific literature, the FDA concluded there was insufficient evidence to remove the device from the market. However, the FDA did release a new guidance document requiring a black box warning for the device and ordered a new postmarketing study comparing Essure's safety and efficacy with laparoscopic tubal sterilization...
December 2, 2016: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/27926584/common-single-nucleotide-polymorphisms-in-transient-receptor-potential-melastatin-type-6-increase-the-risk-for-proton-pump-inhibitor-induced-hypomagnesemia-a-case-control-study
#3
Mark W Hess, Jeroen H F de Baaij, Mark M T J Broekman, Tanya M Bisseling, Bertram J T Haarhuis, Adriaan C I T L Tan, René H M Te Morsche, Joost G J Hoenderop, René J M Bindels, Joost P H Drenth
OBJECTIVE: Proton pump inhibitors (PPIs) are effective drugs for the treatment of gastric acid-related disorders. Serious adverse events are rare for PPIs, but recent data suggest that PPIs cause hypomagnesemia. The aim of this study was to estimate the frequency of PPI-induced hypomagnesemia and to define the risk factors for its development. MATERIALS AND METHODS: A total of 133 chronic users of PPIs were enrolled and patients were distinguished on the basis of their serum Mg concentrations...
December 6, 2016: Pharmacogenetics and Genomics
https://www.readbyqxmd.com/read/27924815/the-relationship-between-eligibility-criteria-and-adverse-events-in-randomized-controlled-trials-of-hematologic-malignancies
#4
A Statler, T Radivoyevitch, C Siebenaller, A T Gerds, M Kalaycio, E Kodish, S Mukherjee, C Cheng, M A Sekeres
To minimize adverse events unrelated to drugs and maximize the likelihood of drug approvals, eligibility criteria for randomized controlled trials (RCTs) may be overly restrictive. The purpose of this study was to determine if RCTs in hematologic malignancies exclude patients irrespective of known toxicities or observed adverse events (AEs). MEDLINE was searched from 1/2010 to 1/2015 for RCTs published in high-impact journals. Of 97 trials, 33% were conducted in leukemia, 28% in lymphoma, 34% in multiple myeloma, and 5% in myelodysplastic syndromes or myelofibrosis...
December 7, 2016: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
https://www.readbyqxmd.com/read/27924751/neurological-sequelae-of-cancer-immunotherapies-and-targeted-therapies
#5
REVIEW
Wolfgang Wick, Anne Hertenstein, Michael Platten
Neurological complications of cancer and of anticancer treatments can be substantially disabling to patients, especially with classic chemotherapies. As a rare but important complication, targeted therapies might also result in similar unwanted effects, partly because inhibition of VEGF is a common downstream effect. Therapeutic antibodies, such as the CD20-depleting antibody rituximab, and underlying haematological malignancies, can induce long-lasting cellular immunosuppression, predisposing patients to opportunistic CNS infections, such as progressive multifocal leukoencephalopathy, where treatment-induced recovery can result in severe reconstitution of immune inflammatory syndromes of the central nervous system...
December 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27924687/the-fluad-case-in-italy-could-it-have-been-dealt-differently
#6
Miriam Levi, Ersilia Sinisgalli, Chiara Lorini, Francesca Santomauro, Martina Chellini, Paolo Bonanni
During the influenza vaccination campaign 2014-2015, the reporting of three deaths within 48 hours of vaccination with Fluad brought the Italian Medicines Agency (AIFA) to pronounce the withdrawal of two batches of vaccine, based on the precautionary principle. Investigations by the Istituto Superiore di Sanità, the National Institute of Health, and by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee at the European Medicines Agency (EMA) responsible for monitoring and assessing the safety profiles of human drugs, concluded that there was a lack of causality between the reported deaths and the vaccines administered...
December 7, 2016: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/27924646/influence-of-anti-tnf-immunogenicity-on-safety-in-rheumatic-disease-a-narrative-review
#7
Andrea Matucci, Daniele Cammelli, Fabrizio Cantini, Delia Goletti, Valentina Marino, Giuseppe Maria Milano, Raffaele Scarpa, Giuliano Tocci, Enrico Maggi, Alessandra Vultaggio
Tumor necrosis factor-alpha (TNF-α) antagonists have been shown to be effective in the treatment of chronic inflammatory rheumatic conditions. The use of anti-TNF agents, combined with improved diagnosis, aggressive regimens and regular monitoring, have substantially improved patient outcomes. However, all biological agents are immunogenic, resulting in the formation of anti-drug antibodies (ADAs), which can neutralize drug activity leading to loss of response and potential relapse. In addition, ADAs can also cause serious adverse events such as infusion hypersensitivity reactions...
December 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27924643/risk-of-infections-using-anti-tnf-agents-in-rheumatoid-arthritis-psoriatic-arthritis-and-ankylosing-spondylitis-a-systematic-review-and-meta-analysis
#8
Silvia Minozzi, Stefanos Bonovas, Theodore Lytras, Valentina Pecoraro, Marien González-Lorenzo, Anan Judina Bastiampillai, Eugenia Maria Gabrielli, Andrea Carlo Lonati, Lorenzo Moja, Michela Cinquini, Valentina Marino, Andrea Matucci, Giuseppe Maria Milano, Giuliano Tocci, Raffaele Scarpa, Delia Goletti, Fabrizio Cantini
Five anti-tumor necrosis factor (anti-TNF) agents have received regulatory approval for use in rheumatology: adalimumab, golimumab, infliximab, certolizumab, and etanercept. Apart from their well-documented therapeutic value, it is still uncertain to what extent they are associated with an increased risk of infectious adverse events. Areas covered: We conducted a systematic review and meta-analysis of published randomized studies to determine the effect of anti-TNF drugs on the occurrence of infectious adverse events (serious infections; tuberculosis; opportunistic infections; any infection)...
December 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27924213/drug-eluting-stents-appear-superior-to-bare-metal-stents-for-vein-graft-pci-in-vessels-up-to-a-stent-diameter-of-4-mm
#9
Oliver P Guttmann, Daniel A Jones, Kassem A Safwan, Sean Gallagher, Krishnaraj S Rathod, Steve Hamshere, Elliot J Smith, Ajay K Jain, Anthony Mathur, Andrew Wragg, Charles J Knight, Roshan Weerackody
BACKGROUND: Research trials have shown improved short-term outcome with drug-eluting stents (DES) over bare metal stents (BMS) in saphenous vein graft (SVG) percutaneous coronary intervention (PCI), primarily by reducing target vessel revascularization (TVR) for in-stent restenosis. We compared the outcomes in patients undergoing SVG stent implantation treated with DES or BMS. In exploratory analyses we investigated the influence of stent generation and diameter. METHODS: Data were obtained from a prospective database of 657 patients who underwent PCI for SVG lesions between 2003 and 2011...
January 2016: Heart International
https://www.readbyqxmd.com/read/27924184/revealed-opportunism-how-physicians-game-prior-authorization-protocols-until-they-are-rescinded
#10
Natan R Kahan, Dan-Andrei Waitman, David P Chinitz
BACKGROUND: Prior authorization (PA) is a management technique that has been implemented to manage the utilization of expensive drugs and to improve the precision of drug prescribing. PA requirements may incentivize physicians to document adverse effects, sometimes falsely, to meet the eligibility requirements. OBJECTIVES: To identify documentation patterns that may facilitate the quantitative analysis of physician gaming and underreporting behaviors associated with the prescribing of angiotensin-converting enzyme (ACE) inhibitors in a primary care setting, and to evaluate the effect of a PA requirement on the documentation of adverse events as a way to receive approval for more expensive drugs...
September 2016: American Health & Drug Benefits
https://www.readbyqxmd.com/read/27923840/osimertinib-for-the-treatment-of-metastatic-epidermal-growth-factor-t970m-positive-non-small-cell-lung-cancer
#11
Sean Khozin, Chana Weinstock, Gideon M Blumenthal, Joyce Cheng, Kun He, Luning Zhuang, Hong Zhao, Rosane Charlab Orbach, Ingrid Fan, Patricia Keegan, Richard Pazdur
On November 13, 2015, FDA granted accelerated approval to osimertinib (TAGRISSO™; AstraZeneca), a breakthrough therapy-designated drug for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, with progression on or after EGFR tyrosine kinase inhibitor therapy. Approval was based on durable tumor response rates in two single-arm, multicenter trials: the dose extension cohort of a first-in-human trial (AURA extension; n=201) and a fixed-dose, activity-estimating trial (AURA2; n=210)...
December 6, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/27923318/herbal-medicines-challenges-in-the-modern-world-part-5-status-and-current-directions-of-complementary-and-alternative-herbal-medicine-worldwide
#12
Elena Yu Enioutina, Emma R Salis, Kathleen M Job, Michael I Gubarev, Lubov V Krepkova, Catherine Mt Sherwin
Herbal medicine (HM) use is growing worldwide. Single herb preparations, ethnic and modern HM formulations are widely used as adjunct therapies or to improve consumer wellbeing. Areas covered: This final part in the publication series summarizes common tendencies in HM use as adjunct or alternative medicine, education of healthcare professionals and consumers, current and proposed guidelines regulating of production. We discuss potential HM-HM and HM-drug interactions that could lead to severe adverse events in situations where HMs are taken without proper medical professional oversight...
December 7, 2016: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/27922765/therapeutic-drug-monitoring-of-anti-tumour-necrosis-factor-%C3%AE-agents-in-inflammatory-bowel-disease
#13
Nikola Mitrev, Rupert W Leong
Anti-TNFα therapy has revolutionised treatment of inflammatory bowel disease, however primary non-response and secondary loss of response are a significant problem. Therapeutic drug monitoring (TDM) has recently emerged as a means of optimising use of anti-TNFα agents. Areas covered: TDM of anti-TNFα agents can guide clinical decisions during treatment failure events, prevent treatment failure events, and potentially result in significant healthcare cost saving. TDM for anti-TNFα agent involves measurement of drug levels and anti-drug antibodies, and can be performed reactively or proactively...
December 6, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27922722/topiramate-versus-carbamazepine-monotherapy-for-epilepsy-an-individual-participant-data-review
#14
REVIEW
Sarah J Nolan, Maria Sudell, Catrin Tudur Smith, Anthony G Marson
BACKGROUND: Epilepsy is a common neurological condition in which abnormal electrical discharges from the brain cause recurrent unprovoked seizures. It is believed that with effective drug treatment, up to 70% of individuals with active epilepsy have the potential to become seizure-free and go into long-term remission shortly after starting drug therapy, the majority of which may be able to achieve remission with a single antiepileptic drug (AED).The correct choice of first-line antiepileptic therapy for individuals with newly diagnosed seizures is of great importance...
December 6, 2016: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/27920801/implications-of-analgesics-use-in-osteoporotic-related-pain-treatment-focus-on-opioids
#15
REVIEW
Renato Vellucci, Consalvo Mattia, Ludovica Celidonio, Rocco Domenico Mediati
Bone loss is asymptomatic and will progress without pain and other symptoms until the occurrence of a fracture. The occurrence of a breaking bone induce acute pain determined and supported by a mechanical, inflammatory and neuropathic component. Very often the acute component evolves in a chronic musculoskeletal component. Overall objectives of the analgesic therapy can be summarized in pain relief, improving sleep, improve mobility, reduce anxiety, emotional component and depression. Osteoporosis is predominantly a condition of the elderly, more likely to have coexisting cardiovascular disease and age-related decline in renal function, receiving treatment for one or more comorbid conditions, taking multiple medications...
May 2016: Clinical Cases in Mineral and Bone Metabolism
https://www.readbyqxmd.com/read/27920527/pharmacokinetics-and-safety-of-dts-108-a-human-oligopeptide-bound-to-sn-38-with-an-esterase-sensitive-cross-linker-in-patients-with-advanced-malignancies-a-phase-i-study
#16
Romain Coriat, Sandrine J Faivre, Olivier Mir, Chantal Dreyer, Stanislas Ropert, Mohammed Bouattour, Robert Desjardins, François Goldwasser, Eric Raymond
BACKGROUND: DTS-108 is a hydrosoluble prodrug, where the SN-38 moiety is covalently linked to a 20-amino acid vector peptide by a specific esterase-sensitive cross-linker, releasing 7-ethyl-10-hydroxycampthotecin (SN-38) by esterase bond cleavage. METHODS: The pharmacokinetics of DTS-108, adverse events graded according to NCI-CTCv3.1, dose-limiting toxicities at cycle 1, the maximum tolerated dose (MTD), and the recommended Phase II dose (RP2D) of intravenous DTS-108 (1-2 hours) every 2 weeks were evaluated in a first-in-human Phase I study in patients with advanced/metastatic carcinomas, according to an accelerated dose escalation design...
2016: International Journal of Nanomedicine
https://www.readbyqxmd.com/read/27920503/adverse-events-and-patients-perceived-health-related-quality-of-life-at-the-end-of-multidrug-resistant-tuberculosis-treatment-in-namibia
#17
Evans L Sagwa, Nunurai Ruswa, Farai Mavhunga, Timothy Rennie, Hubert Gm Leufkens, Aukje K Mantel-Teeuwisse
PURPOSE: The health-related quality of life (HRQoL) of patients completing multidrug-resistant tuberculosis (MDR-TB) treatment in Namibia and whether the occurrence of adverse events influenced patients' rating of their HRQoL was evaluated. PATIENTS AND METHODS: A cross-sectional analytic survey of patients completing or who recently completed MDR-TB treatment was conducted. The patients rated their HRQoL using the simplified Short Form-™ (SF-8) questionnaire consisting of eight Likert-type questions...
2016: Patient Preference and Adherence
https://www.readbyqxmd.com/read/27919915/chemoprevention-of-colorectal-cancer-in-individuals-with-previous-colorectal-neoplasia-systematic-review-and-network-meta-analysis
#18
Parambir S Dulai, Siddharth Singh, Evelyn Marquez, Rohan Khera, Larry J Prokop, Paul J Limburg, Samir Gupta, Mohammad Hassan Murad
OBJECTIVE:  To assess the comparative efficacy and safety of candidate agents (low and high dose aspirin, non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs), calcium, vitamin D, folic acid, alone or in combination) for prevention of advanced metachronous neoplasia (that is, occurring at different times after resection of initial neoplasia) in individuals with previous colorectal neoplasia, through a systematic review and network meta-analysis. DATA SOURCES:  Medline, Embase, Web of Science, from inception to 15 October 2015; clinical trial registries...
December 5, 2016: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/27919281/incidence-causes-and-consequences-of-preventable-adverse-drug-events-protocol-for-an-overview-of-reviews
#19
Brian Hutton, Salmaan Kanji, Erika McDonald, Fatemeh Yazdi, Dianna Wolfe, Kednapa Thavorn, Sally Pepper, Laurie Chapman, Becky Skidmore, David Moher
BACKGROUND: Medication errors represent a noteworthy source of harm to patients. In recent years, several systematic reviews have assessed the frequency and causes of these events, as well as other factors such as commonly associated drugs, their incidence in different specialties, and their consequences to patients. Despite this past literature, there remains a need to study discrepancies between these reviews and establish the current state of the evidence. The planned review will bring together, compare, and contract existing evidence related to the occurrence of medication errors in acute and continuing/long-term care settings...
December 5, 2016: Systematic Reviews
https://www.readbyqxmd.com/read/27919207/safety-and-effectiveness-of-24-week-treatment-with-iguratimod-a-new-oral-disease-modifying-antirheumatic-drug-for-patients-with-rheumatoid-arthritis-interim-analysis-of-a-postmarketing-surveillance-study-of-2679-patients-in-japan
#20
Tsuneyo Mimori, Masayoshi Harigai, Tatsuya Atsumi, Takao Fujii, Masataka Kuwana, Hiroaki Matsuno, Shigeki Momohara, Syuji Takei, Naoto Tamura, Yoshinari Takasaki, Satoshi Ikeuchi, Satoru Kushimoto, Takao Koike
OBJECTIVE: To determine the real-world safety and effectiveness of iguratimod (IGU) for rheumatoid arthritis (RA), a 52-week, Japanese, postmarketing surveillance study was conducted. An interim analysis at week 24 was performed. METHODS: This study included all RA patients who received IGU following its introduction to the market. All adverse events (AEs) and adverse drug reactions (ADRs) were collected. Effectiveness was evaluated by the change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) from baseline to week 24...
December 6, 2016: Modern Rheumatology
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