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Drug Safety: An International Journal of Medical Toxicology and Drug Experience

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https://www.readbyqxmd.com/read/30377994/correction-to-abstracts-of-the-18th-isop-annual-meeting-pharmacovigilance-without-borders-geneva-switzerland-11-14-november-2018
#1
(no author information available yet)
ISoP18-1156 From Database to Diagnosis: 'Intelligent Query', a Tool to Help With Safety Signal Evaluation".
October 31, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30368737/fluoroquinolones-and-cardiovascular-risk-a-systematic-review-meta-analysis-and-network-meta-analysis
#2
Einat Gorelik, Reem Masarwa, Amichai Perlman, Victoria Rotshild, Momen Abbasi, Mordechai Muszkat, Ilan Matok
INTRODUCTION: Several fluoroquinolone antibiotics have been associated with cardiac adverse effects, leading to the withdrawal of some of these agents from the market. Cardiac side effects such as QT prolongation and torsades de pointes (TdP) have also been observed with fluoroquinolones currently on the market. In order to evaluate the cardiac risk of fluoroquinolones as a class, and the comparative risk for each individual drug, we conducted a systematic review, meta-analysis, and network meta-analysis...
October 27, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30361989/previous-drug-exposure-in-patients-hospitalised-for-acute-liver-injury-a-case-population-study-in-the-french-national-healthcare-data-system
#3
Nicholas Moore, Stéphanie Duret, Adeline Grolleau, Régis Lassalle, Vanessa Barbet, Mai Duong, Nicolas Thurin, Cécile Droz-Perroteau, Sinem Ezgi Gulmez
INTRODUCTION: Acute liver injury (ALI) is a major reason for stopping drug development or removing drugs from the market. Hospitalisation for ALI is relatively rare for marketed drugs, justifying studies in large-scale databases such as the nationwide Système National des Données de Santé (SNDS), which covers 99% of the French population. METHODS: SNDS was queried over 2010-2014 for all hospital admissions for acute toxic liver injuries not associated with a possible other cause, using a case-population approach...
October 25, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30357649/prevalence-of-drug-prescriptions-and-potential-safety-in-patients-with-cirrhosis-a-retrospective-real-world-study
#4
Rianne A Weersink, Katja Taxis, Joost P H Drenth, Eline Houben, Herold J Metselaar, Sander D Borgsteede
INTRODUCTION: Patients with cirrhosis are at risk for adverse drug reactions (ADRs) due to altered pharmacokinetics and pharmacodynamics. We aimed to determine the prevalence of drug prescriptions and the potential safety of these prescriptions in a real-world cohort of patients with cirrhosis. METHODS: This was a retrospective cohort study based on linked real-world data from the Out-patient Pharmacy Database and the Hospitalisation Database of the PHARMO Database Network...
October 24, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30357648/the-role-of-european-patient-organizations-in-pharmacovigilance
#5
Cristiano Matos, Gerda Weits, Florence van Hunsel
INTRODUCTION: Patient organizations have a privileged position to be active agents for promoting pharmacovigilance and patient engagement, encouraging direct patient reporting and improving the awareness of pharmacovigilance. AIM: The objective of this study was to understand the role of European patient organizations as stakeholders to optimize patient involvement in pharmacovigilance. METHODS: A descriptive correlational study was conducted to investigate the opinions and attitudes of patient organizations regarding general patient involvement in pharmacovigilance, and their initiatives to support drug safety through a web-based questionnaire during the months of March and April 2018...
October 24, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30343418/drug-induced-liver-injury-highlights-of-the-recent-literature
#6
REVIEW
Mark Real, Michele S Barnhill, Cory Higley, Jessica Rosenberg, James H Lewis
Drug-induced liver injury (DILI), herbal-induced liver injury, and herbal and dietary supplement (HDS)-induced liver injury are an important aspect of drug safety. Knowledge regarding responsible drugs, mechanisms, risk factors, and the diagnostic tools to detect liver injury have continued to grow in the past year. This review highlights what we considered the most significant publications from among more than 1800 articles relating to liver injury from medications, herbal products, and dietary supplements in 2017 and 2018...
October 20, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30343417/artificial-intelligence-and-the-future-of-the-drug-safety-professional
#7
Karolina Danysz, Salvatore Cicirello, Edward Mingle, Bruno Assuncao, Niki Tetarenko, Ruta Mockute, Danielle Abatemarco, Mark Widdowson, Sameen Desai
The healthcare industry, and specifically the pharmacovigilance industry, recognizes the need to support the increasing amount of data received from individual case safety reports (ICSRs). To cope with this increase, more healthcare and qualified professionals are required to capture and evaluate the data. To address the evolving landscape, it will be necessary to embrace assistive technologies such as artificial intelligence (AI) at scale. AI in the field of pharmacovigilance will possibly result in the transformation of the drug safety (DS) professional's daily work life and their career development...
October 20, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30341678/comment-on-assessment-of-the-utility-of-social-media-for-broad-ranging-statistical-signal-detection-in-pharmacovigilance-results-from-the-web-radr-project
#8
LETTER
Cedric Bousquet, Bissan Audeh, Florelle Bellet, Agnès Lillo-Le Louët
No abstract text is available yet for this article.
October 19, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30341677/safety-of-follitropin-alfa-lutropin-alfa-for-stimulation-of-follicular-development
#9
Nadezda Abramova, Julie Hubbard, Joan Schertz, Emilia Richter
INTRODUCTION: Recombinant human luteinizing hormone (r-hLH) is used in a fixed-ratio combination with recombinant human follicle-stimulating hormone (r-hFSH) for the stimulation of follicular development. OBJECTIVE: The objective of this article was to conduct a review of safety data to evaluate the risks of r-hFSH/r-hLH treatment. METHODS: Data were retrieved from the Global Safety Database (Merck KGaA, Darmstadt, Germany) including reports from healthcare professionals, patients, health authorities, clinical trials, non-interventional studies, and the literature...
October 19, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30328587/correction-to-liver-safety-of-fasiglifam-tak-875-in-patients-with-type-2-diabetes-review-of-the-global-clinical-trial-experience
#10
John F Marcinak, Melvin S Munsaka, Paul B Watkins, Takashi Ohira, Neila Smith
In the original publication of the article, the ALT and AST values in Fig. 5a-e were capped at 10× ULN, which did not accurately reflect the narrative provided for each case. In this correction, the original Fig. 5a-e (Fig. 1a-e) and the correct Fig. 5a-5e (Fig. 2a-e) are published.
October 17, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30302624/real-world-evidence-time-for-a-switch
#11
Rachel E Sobel, Andrew Bate, Robert F Reynolds
No abstract text is available yet for this article.
October 9, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30298309/preventing-future-deaths-from-medicines-responses-to-coroners-concerns-in-england-and-wales
#12
Robin E Ferner, Tohfa Ahmad, Zainab Babatunde, Anthony R Cox
INTRODUCTION: Coroners inquire into sudden, unexpected, or unnatural deaths. We have previously established 99 cases (100 deaths) in England and Wales in which medicines or part of the medication process or both were mentioned in coroners' 'Regulation 28 Reports to Prevent Future Deaths' (coroners' reports). OBJECTIVE: We wished to see what responses were made by National Health Service (NHS) organizations and others to these 99 coroners' reports. METHODS: Where possible, we identified the party or parties to whom these reports were addressed (names were occasionally redacted)...
October 8, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30291596/authors-reply-to-katsuhiro-toda-s-comment-on-proton-pump-inhibitor-use-and-risk-of-developing-alzheimer-s-disease-or-vascular-dementia-a-case-control-analysis
#13
LETTER
Patrick Imfeld, Michael Bodmer, Susan S Jick, Christoph R Meier
No abstract text is available yet for this article.
October 5, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30291595/comment-on-proton-pump-inhibitor-use-and-risk-of-developing-alzheimer-s-disease-or-vascular-dementia-a-case-control-analysis
#14
LETTER
Katsuhiro Toda
No abstract text is available yet for this article.
October 5, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30284215/surveillance-of-drug-safety-during-pregnancy-insight-in-current-international-activities-future-intentions-and-need-for-support-of-national-pharmacovigilance-centres
#15
Agnes Kant, Loes de Vries, Leàn Rolfes
INTRODUCTION: Surveillance of drug safety during pregnancy is a special interest of pharmacovigilance (PV). The role that national PV centres take in this field is, however, unclear. AIM: The aim of this study was to provide insight into current activities, future intentions and need for support of national PV centres in the field of drug safety during pregnancy. METHOD: A web-based questionnaire was used to ask PV centres about their current activities concerning the surveillance of drug safety during pregnancy, their intentions to implement or improve activities and need for support...
October 3, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30284214/pharmacoepidemiologic-evaluation-of-birth-defects-from-health-related-postings-in-social-media-during-pregnancy
#16
Su Golder, Stephanie Chiuve, Davy Weissenbacher, Ari Klein, Karen O'Connor, Martin Bland, Murray Malin, Mondira Bhattacharya, Linda J Scarazzini, Graciela Gonzalez-Hernandez
INTRODUCTION: Adverse effects of medications taken during pregnancy are traditionally studied through post-marketing pregnancy registries, which have limitations. Social media data may be an alternative data source for pregnancy surveillance studies. OBJECTIVE: The objective of this study was to assess the feasibility of using social media data as an alternative source for pregnancy surveillance for regulatory decision making. METHODS: We created an automated method to identify Twitter accounts of pregnant women...
October 3, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30276630/potential-direct-costs-of-adverse-drug-events-and-possible-cost-savings-achievable-by-their-prevention-in-tuscany-italy-a-model-based-analysis
#17
Irma Convertino, Stefano Salvadori, Alessandro Pecori, Maria Teresa Galiulo, Sara Ferraro, Maria Parrilli, Tiberio Corona, Giuseppe Turchetti, Corrado Blandizzi, Marco Tuccori
INTRODUCTION: Adverse drug events (ADEs) may represent an important item of expenditure for healthcare systems and their prevention could be associated with a relevant cost saving. OBJECTIVE: The objective of this study was to simulate the annual economic burden for ADEs in Tuscany (Italy) and the potential cost savings related to avoidable ADEs. METHODS: A systematic review was performed, according to the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) and Meta-analysis Of Observational Studies in Epidemiology (MOOSE) statements, on observational studies published from 2006 to 2016 in MEDLINE and EMBASE, focusing on direct costs of ADEs in the inpatient setting from high-income countries...
October 1, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30269245/the-role-of-european-healthcare-databases-for-post-marketing-drug-effectiveness-safety-and-value-evaluation-where-does-italy-stand
#18
REVIEW
Gianluca Trifirò, Rosa Gini, Francesco Barone-Adesi, Ettore Beghi, Anna Cantarutti, Annalisa Capuano, Carla Carnovale, Antonio Clavenna, Mirosa Dellagiovanna, Carmen Ferrajolo, Matteo Franchi, Ylenia Ingrasciotta, Ursula Kirchmayer, Francesco Lapi, Roberto Leone, Olivia Leoni, Ersilia Lucenteforte, Ugo Moretti, Alessandro Mugelli, Luigi Naldi, Elisabetta Poluzzi, Concita Rafaniello, Federico Rea, Janet Sultana, Mauro Tettamanti, Giuseppe Traversa, Alfredo Vannacci, Lorenzo Mantovani, Giovanni Corrao
Enormous progress has been made globally in the use of evidence derived from patients' clinical information as they access their routine medical care. The value of real-world data lies in their complementary nature compared with data from randomised controlled trials: less detailed information on drug efficacy but longer observational periods and larger, more heterogeneous study populations reflecting clinical practice because individuals are included who would not usually be recruited in trials. Real-world data can be collected in various types of electronic sources, such as electronic health records, claims databases and drug or disease registries...
September 29, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30269244/pharmacovigilance-in-india-present-scenario-and-future-challenges
#19
V Kalaiselvan, Sushma Srivastava, Abhishank Singh, S K Gupta
Pharmacovigilance in India was initiated way back in 1986 with a formal adverse drug reaction (ADR) monitoring system, under supervision of the drug controller of India. India joined the World Health Organization (WHO) Programme for International Drug Monitoring in 1998, but was not successful. Later, the National Programme of Pharmacovigilance was launched in 2005, and was renamed as the Pharmacovigilance Programme of India (PvPI) in 2010. In consideration of having a robust pharmacovigilance system in India, steps were taken...
September 29, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/30269243/authors-reply-to-cohen-et-al-s-comment-on-central-demyelinating-diseases-after-vaccination-against-hepatitis-b-virus-a-disproportionality-analysis-within-the-vaers-database
#20
LETTER
Julie Mouchet, Bernard Bégaud
No abstract text is available yet for this article.
September 29, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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