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https://www.readbyqxmd.com/read/27894343/post-marketing-withdrawal-of-anti-obesity-medicinal-products-because-of-adverse-drug-reactions-a-systematic-review
#1
Igho J Onakpoya, Carl J Heneghan, Jeffrey K Aronson
BACKGROUND: We identified anti-obesity medications withdrawn since 1950 because of adverse drug reactions after regulatory approval, and examined the evidence used to support such withdrawals, investigated the mechanisms of the adverse reactions, and explored the trends over time. METHODS: We conducted searches in PubMed, the World Health Organization database of drugs, the websites of drug regulatory authorities, and selected full texts, and we hand searched references in retrieved documents...
November 29, 2016: BMC Medicine
https://www.readbyqxmd.com/read/27891350/hypersensitivity-with-inhalational-budesonide-an-under-recognised-entity
#2
Pramod Kumar Sharma, Neeraj Gupta, Najmul Hasan, Bhaskar Krishnamurthy, Surjit Singh
Hypersensitivity reactions are commonly encountered with drugs such as beta lactams, sulphonamides, allopurinol etc., Corticosteroids are frequently employed in the treatment of drug induced allergic reactions. Therefore, it is highly unlikely that a corticosteroid itself may cause such a reaction as an adverse effect. We had encountered a rare case of hypersensitivity reaction with inhalational budesonide in an eight-year-old boy. The patient developed maculopapular rashes over the back, buttocks and legs accompanied with pruritus within four hours of administration of the first dose...
October 2016: Journal of Clinical and Diagnostic Research: JCDR
https://www.readbyqxmd.com/read/27865471/satisfaction-and-treatment-adherence-in-erectile-dysfunction-in-the-medium-and-long-term
#3
J Panach-Navarrete, A Morales-Giraldo, C Ferrandis-Cortés, F García-Morata, J C Pastor-Lence, J M Martínez-Jabaloyas
INTRODUCTION: The aim of this study was to show the satisfaction and treatment adherence in erectile dysfunction (ED) in the medium and long term. MATERIAL AND METHODS: A descriptive, comparative study was conducted in 2 centres through telephone interviews with patients who came for an initial visit between 2012 and 2014 for ED. A complete case history review was conducted on the use of and withdrawal from treatment. For current use, the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) and the Global Assessment Questionnaire (GAQ) were filled out; for past use, only the GAQ was filled out...
November 16, 2016: Actas Urologicas Españolas
https://www.readbyqxmd.com/read/27854302/severe-cutaneous-adverse-reactions-the-pharmacogenomics-from-research-to-clinical-implementation
#4
REVIEW
Shih-Chi Su, Shuen-Iu Hung, Wen-Lang Fan, Ro-Lan Dao, Wen-Hung Chung
Severe cutaneous adverse reactions (SCARs), previously thought to be idiosyncratic or unpredictable, are a deadly form of adverse drug reactions with skin manifestations. Current pharmacogenomic studies of SCARs have made important strides, as the prevention of SCARs, to some extent, appears attainable with the identification of genetic variants for genes encoding drug-metabolizing enzymes and human leukocyte antigens (HLAs). Despite the improvement of incidence, a treatment guideline for this devastating condition is still unavailable, highlighting the inadequacy of contemporary accepted therapeutic interventions...
November 15, 2016: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/27825009/effect-of-anakinra-on-recurrent-pericarditis-among-patients-with-colchicine-resistance-and-corticosteroid-dependence-the-airtrip-randomized-clinical-trial
#5
Antonio Brucato, Massimo Imazio, Marco Gattorno, George Lazaros, Silvia Maestroni, Mara Carraro, Martina Finetti, Davide Cumetti, Alessandra Carobbio, Nicolino Ruperto, Renzo Marcolongo, Monia Lorini, Alessandro Rimini, Anna Valenti, Gian Luca Erre, Maria Pia Sormani, Riccardo Belli, Fiorenzo Gaita, Alberto Martini
Importance: Anakinra, an interleukin 1β recombinant receptor antagonist, may have potential to treat colchicine-resistant and corticosteroid-dependent recurrent pericarditis. Objective: To determine the efficacy of anakinra for colchicine-resistant and corticosteroid-dependent recurrent pericarditis. Design, Setting, and Participants: The Anakinra-Treatment of Recurrent Idiopathic Pericarditis (AIRTRIP) double-blind, placebo-controlled, randomized withdrawal trial (open label with anakinra followed by a double-blind withdrawal step with anakinra or placebo until recurrent pericarditis occurred) conducted among 21 consecutive patients enrolled at 3 Italian referral centers between June and November 2014 (end of follow-up, October 2015)...
November 8, 2016: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/27783843/azathioprine-or-6-mercaptopurine-for-induction-of-remission-in-crohn-s-disease
#6
REVIEW
Nilesh Chande, Cassandra M Townsend, Claire E Parker, John K MacDonald
BACKGROUND: The results from controlled clinical trials investigating the efficacy of azathioprine and 6-mercaptopurine for the treatment of active Crohn's disease have been conflicting and controversial. An updated meta-analysis was performed to assess the effectiveness of these drugs for the induction of remission in active Crohn's disease. OBJECTIVES: The primary objective was to determine the efficacy and safety of azathioprine and 6-mercaptopurine for induction of remission in active Crohn's disease...
October 26, 2016: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/27779771/efficacy-and-tolerability-of-antiepileptic-drugs-in-patients-with-focal-epilepsy-systematic-review-and-network-meta-analyses
#7
Marília Silveira de Almeida Campos, Lorena Rocha Ayres, Manuela Roque Siane Morelo, Fabiana Angelo Marques, Leonardo Régis Leira Pereira
Several newer antiepileptic drugs (AEDs) have been introduced into clinical practice, offering choices for individualizing the treatment of epilepsy since AEDs have different efficacy and tolerability profiles. In particular, questions exist regarding which AEDs are the best options for the monotherapy of focal epilepsy. Is carbamazepine (CBZ), which is considered the standard treatment for focal epilepsy, still the best option for monotherapy of focal epilepsy, despite the emergence of new AEDs? In this systematic review, we compared the relative tolerability of all available AEDs for monotherapy of all types of epilepsy as well as their efficacy in the monotherapy of focal epilepsy...
October 25, 2016: Pharmacotherapy
https://www.readbyqxmd.com/read/27716721/guidelines-for-the-management-of-stevens-johnson-syndrome-toxic-epidermal-necrolysis-an-indian-perspective
#8
Lalit Kumar Gupta, Abhay Mani Martin, Nidheesh Agarwal, Paschal D'Souza, Sudip Das, Rajesh Kumar, Sushil Pande, Nilay Kanti Das, Muthuvel Kumaresan, Piyush Kumar, Anubhav Garg, Saurabh Singh
BACKGROUND: Stevens-Johnson syndrome and toxic epidermal necrolysis are severe, life-threatening mucocutaneous adverse drug reactions with a high morbidity and mortality that require immediate medical care. The various immunomodulatory treatments include systemic corticosteroids, cyclosporine, intravenous immunoglobulin, cyclophosphamide, plasmapheresis and tumor necrosis factor-α inhibitors. AIM: The ideal therapy of Stevens-Johnson syndrome/toxic epidermal necrolysis still remains a matter of debate as there are only a limited number of studies of good quality comparing the usefulness of different specific treatments...
November 2016: Indian Journal of Dermatology, Venereology and Leprology
https://www.readbyqxmd.com/read/27707789/a-randomised-double-blind-placebo-controlled-trial-of-trichuris-suis-ova-tso-in-active-crohn-s-disease
#9
Jürgen Schölmerich, Klaus Fellermann, Frank W Seibold, Gerhard Rogler, Jost Langhorst, Stefanie Howaldt, Gottfried Novacek, Andreas Munk Petersen, Oliver Bachmann, Harald Matthes, Norbert Hesselbarth, Niels Teich, Jan Wehkamp, Jochen Klaus, Claudia Ott, Karin Dilger, Roland Greinwald, Ralph Mueller
BACKGROUND & AIMS: To investigate the efficacy and safety of three different dosages of embryonated, viable eggs of Trichuris suis (TSO) versus placebo for induction of remission in mildly-to-moderately active ileocolonic, uncomplicated Crohn's disease (CD). METHODS: Adults with active CD (n=252) randomly received six fortnightly doses of 250, 2500 or 7500 TSO/15 ml suspension/day (TSO 250, TSO 2500, TSO 7500), or 15ml placebo solution/day, in a double-blind fashion, with four weeks' follow-up...
October 5, 2016: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/27679410/guidelines-for-the-management-of-stevens-johnson-syndrome-toxic-epidermal-necrolysis-an-indian-perspective
#10
Lalit Kumar Gupta, Abhay Mani Martin, Nidheesh Agarwal, Paschal D'Souza, Sudip Das, Rajesh Kumar, Sushil Pande, Nilay Kanti Das, Muthuvel Kumareshan, Piyush Kumar, Anubhav Garg, Saurabh Singh
BACKGROUND: Stevens-Johnson syndrome and toxic epidermal necrolysis are severe, life-threatening mucocutaneous adverse drug reactions with a high morbidity and mortality that require immediate medical care. The various immunomodulatory treatments include systemic corticosteroids, cyclosporine, intravenous immunoglobulin, cyclophosphamide, plasmapheresis and tumor necrosis factor-α inhibitors. AIM: The ideal therapy of Stevens-Johnson syndrome/toxic epidermal necrolysis still remains a matter of debate as there are only a limited number of studies of good quality comparing the usefulness of different specific treatments...
September 26, 2016: Indian Journal of Dermatology, Venereology and Leprology
https://www.readbyqxmd.com/read/27578085/drug-induced-itch-management
#11
Toshiya Ebata
Drugs may cause itching as a concomitant symptom of drug-induced skin reactions or in the form of pruritus without skin lesions. Drug-induced itch is defined as generalized itching without skin lesions, caused by a drug. Itching associated with drug-induced cholestasis is among the common dermatologic adverse events (dAEs) that induce itching. Some drugs such as opioids, antimalarials, and hydroxyethyl starch are known to induce itching without skin lesions. The clinical features and underlying proposed mechanisms of itching caused by these drugs have been specifically investigated...
2016: Current Problems in Dermatology
https://www.readbyqxmd.com/read/27574928/dress-syndrome-following-metformin-administration-a-case-report-and-review-of-the-literature
#12
Prakruthi Voore, Chibuzo Odigwe, Aibek E Mirrakhimov, Dana Rifai, Nkemakolam A Iroegbu
The drug rash with eosinophilia and systemic symptoms syndrome also known as DRESS syndrome refers to an idiosyncratic drug reaction commonly characterized by rashes, fever, lymphadenopathy, and internal organ involvement. We report a case of this syndrome in a 40-year-old man presenting with a rash, generalized pruritus, lymphadenopathy, and eosinophilia after metformin treatment. To the best of our knowledge, this is the first report linking metformin to the DRESS syndrome. The patient improved remarkably with drug withdrawal...
August 17, 2016: American Journal of Therapeutics
https://www.readbyqxmd.com/read/27572807/dress-syndrome-caused-by-cross-reactivity-between-vancomycin-and-subsequent-teicoplanin-administration-a-case-report
#13
Daisuke Miyazu, Nobuhiro Kodama, Daiki Yamashita, Hirokazu Tanaka, Sachiko Inoue, Osamu Imakyure, Masaaki Hirakawa, Hideki Shuto, Yasufumi Kataoka
BACKGROUND Drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome is a potentially life-threatening syndrome comprising severe skin eruption, fever, eosinophilia, lymphadenopathy, and involvement of internal organs. Here, we describe a case of DRESS syndrome caused by cross-reactivity between vancomycin and subsequent teicoplanin administration. CASE REPORT A 79-year-old male was admitted to our hospital for the treatment of injuries incurred in a traffic accident. Eosinophilia and lung dysfunction appeared after vancomycin administration...
2016: American Journal of Case Reports
https://www.readbyqxmd.com/read/27551882/peginesatide-for-the-treatment-of-anemia-due-to-chronic-kidney-disease-an-unfulfilled-promise
#14
Terhi Hermanson, Charles L Bennett, Iain C Macdougall
INTRODUCTION: The introduction of recombinant human erythropoietin revolutionized the management of anemia in patients with chronic kidney disease (CKD). In order to circumvent costly recombinant DNA technology, synthetic chemistry techniques were used to manufacture peginesatide, a synthetic peptide that bore no resemblance to previous erythropoiesis-stimulating agents (ESAs), and yet was capable of stimulating erythropoiesis. Compared with other ESAs, peginesatide was deemed to have advantages related to immunogenicity, administration schedule, and cost...
October 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27451390/nivolumab-for-classical-hodgkin-s-lymphoma-after-failure-of-both-autologous-stem-cell-transplantation-and-brentuximab-vedotin-a-multicentre-multicohort-single-arm-phase-2-trial
#15
Anas Younes, Armando Santoro, Margaret Shipp, Pier Luigi Zinzani, John M Timmerman, Stephen Ansell, Philippe Armand, Michelle Fanale, Voravit Ratanatharathorn, John Kuruvilla, Jonathon B Cohen, Graham Collins, Kerry J Savage, Marek Trneny, Kazunobu Kato, Benedetto Farsaci, Susan M Parker, Scott Rodig, Margaretha G M Roemer, Azra H Ligon, Andreas Engert
BACKGROUND: Malignant cells of classical Hodgkin's lymphoma are characterised by genetic alterations at the 9p24.1 locus, leading to overexpression of PD-1 ligands and evasion of immune surveillance. In a phase 1b study, nivolumab, a PD-1-blocking antibody, produced a high response in patients with relapsed and refractory classical Hodgkin's lymphoma, with an acceptable safety profile. We aimed to assess the clinical benefit and safety of nivolumab monotherapy in patients with classical Hodgkin's lymphoma after failure of both autologous stem-cell transplantation and brentuximab vedotin...
September 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27450969/treatment-efficacy-and-safety-of-low-dose-azathioprine-in-chronic-active-ulcerative-colitis-patients-a-meta-analysis-and-systemic-review
#16
Zi Jian Luan, Yue Li, Xin Yu Zhao, Li Wang, Ying Hao Sun, Shi Yao Wang, Jia Ming Qian
OBJECTIVE: To pool the data of studies and to evaluate the efficacy and safety of low-dose azathioprine (AZA) for treating patients with chronic active ulcerative colitis. METHODS: Research subjects were patients with chronic active UC, including steroid-dependent colitis, steroid-refractory colitis patients or patients who couldn't achieve remission after full-dose 5-ASA treatment. The treatment of chronic active UC patients was low-dose AZA (≤1.5 mg/kg/d)...
July 23, 2016: Journal of Digestive Diseases
https://www.readbyqxmd.com/read/27373095/-efficacy-of-sublingual-immunotherapy-in-children-with-allergic-rhinitis
#17
Hang Lin, Shuyu Che, Rongjun Lin, Na Li
OBJECTIVE: To evaluate the efficacy of sublingual immunotherapy with dermatophagoides farina drops on children with allergic rhinitis. METHOD: This was retrospective study analyzing the efficacy of dermatophaguides farinae drops SLIT in 110 patients (aged 4-14 years old) with house dust mites induced allergic rhinitis (without asthma). All the patients were divided into the SLIT group (n = 60) and drug group (n = 50). Patients in SLIT group received sublingual immunotherapy combined with symptomatic medication, and patients in drug group only received symptomatic medication...
February 2016: Journal of Clinical Otorhinolaryngology, Head, and Neck Surgery
https://www.readbyqxmd.com/read/27344345/validation-of-precision-cut-liver-slices-to-study-drug-induced-cholestasis-a-transcriptomics-approach
#18
Suresh Vatakuti, Peter Olinga, Jeroen L A Pennings, Geny M M Groothuis
Hepatotoxicity is one of the major reasons for withdrawal of drugs from the market. Therefore, there is a need to screen new drugs for hepatotoxicity in humans at an earlier stage. The aim of this study was to validate human precision-cut liver slices (PCLS) as an ex vivo model to predict drug-induced cholestasis and identify the possible mechanisms of cholestasis-induced toxicity using gene expression profiles. Five hepatotoxicants, which are known to induce cholestasis (alpha-naphthyl isothiocyanate, chlorpromazine, cyclosporine, ethinyl estradiol and methyl testosterone) were used at concentrations inducing low (<30 %) and medium (30-50 %) toxicity, based on ATP content...
June 25, 2016: Archives of Toxicology
https://www.readbyqxmd.com/read/27334199/a-survey-on-computational-approaches-to-predicting-adverse-drug-reactions
#19
Yun-Gu Chen, Yin-Ying Wang, Xing-Ming Zhao
Adverse drug reactions (ADRs) are the leading factors of drug attrition in drug development and post-market drug withdrawal. The identification of potential ADRs can help prevent the failure of drug discovery and improve development efficiency. Furthermore, elucidating possible ADRs for known drugs can help better understand the mechanism of drug actions and even find new indications of old drugs. Unfortunately, only the ADRs of some well-studied drugs are available and our knowledge about ADRs of available drugs is far from complete...
2016: Current Topics in Medicinal Chemistry
https://www.readbyqxmd.com/read/27330371/drug-safety-the-concept-inception-and-its-importance-in-patients-health
#20
REVIEW
Thamir M Alshammari
BACKGROUND: Drug safety is one of the hottest topics in daily medical practice, particularly with regard to approving new medication or questioning the possibility of withdrawing a drug from the market. AIM: The aim of this review is to highlight the importance of the drug safety concept and its impact on patients' health. METHODS: A literature search was conducted using Pubmed®, EMBASE®, EBSCO and Medline in the period between 1980 and 2013...
July 2016: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
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