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Simona T Hübner, Raffaela Bertoli, Alexandra E Rätz Bravo, Martina Schaueblin, Manuel Haschke, Kathrin Scherer, Alessandro Ceschi, Anne B Leuppi-Taegtmeyer
BACKGROUND: The spectrum of inflammatory marker response in DRESS (drug reaction with eosinophilia and systemic symptoms) syndrome has not been systematically characterized. METHODS: An epidemiological biomarker study of C-reactive protein (CRP) and procalcitonin (PCT) values in patients with DRESS syndrome reported at 2 regional pharmacovigilance centers in Switzerland or published in the medical literature 2008-2016 was performed. RESULTS: Ninety-four DRESS cases were studied...
April 13, 2018: International Archives of Allergy and Immunology
M Rochoy, R Thomas, J Béné, D Deleplanque, M-C Vantyghem, S Gautier, D Deplanque
INTRODUCTION: Age-related androgenic deficiency (DALA) is a pathology that is increasingly cited in recent publications. The cardiovascular risk of testosterone is debated: present for the FDA, absent for the European Medicines Agency in 2015. Our objective was to analyze the association between androgens and vascular pathologies in adverse reactions reported in pharmacovigilance databases. MATERIAL AND METHOD: We conducted a retrospective case series study of the French and Canadian pharmacovigilance databases for the period 2005-2015...
April 9, 2018: Progrès en Urologie
M Salem, T Reichlin, D Fasel, A Leuppi-Taegtmeyer
Background: Literature about torsade de pointes induced by azole antifungal agents is scarce, despite the well-known association. Furthermore, little is known about the latency time between commencing an azole antifungal agent and developing torsade de pointes. The objectives of the present study were therefore to identify all cases of torsade de pointes associated with systemic azole antifungal use reported to the WHO monitoring centre (Uppsala, Sweden) and to determine the latency times between commencing the azole and developing torsade de pointes...
June 30, 2017: Global Cardiology Science & Practice
Helen Byomire Ndagije, Victoria Nambasa, Leonard Manirakiza, Donna Kusemererwa, Dan Kajungu, Sten Olsson, Niko Speybroeck
INTRODUCTION: Uganda has rapidly increased access to antimalarial medicines in an effort to address the huge malaria disease burden. Pharmacovigilance information is important to guide policy decisions. OBJECTIVES: The purpose of this study was to establish the burden of adverse drug reactions (ADRs) and associated risk factors for developing ADRs to artemisinin-based antimalarial treatment in Uganda. METHODS: An active follow-up study was conducted between April and July 2017 in a cohort of patients receiving treatment for uncomplicated malaria in the Iganga, Mayuge, and Kampala districts...
April 7, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
E Raschi, E Poluzzi, F Salvo, A Pariente, F De Ponti, G Marchesini, U Moretti
Sodium-glucose co-transporter-2 inhibitors (SGLT2-Is) have consistently demonstrated a clinically significant reduction of cardiovascular mortality. However, their safety in clinical practice is still incompletely characterized, and post-marketing monitoring is required considering the expected increase in clinical use. Different analyses of international spontaneous reporting systems, known as disproportionality analyses (DAs), have highlighted the occurrence of ketoacidosis, amputations, acute renal failure and skin toxicity...
March 1, 2018: Nutrition, Metabolism, and Cardiovascular Diseases: NMCD
Heide Stirnadel-Farrant, Mahesh Kudari, Nadia Garman, Jessica Imrie, Bikramjit Chopra, Stefania Giannelli, Michela Gabaldo, Ambra Corti, Stefano Zancan, Alessandro Aiuti, Maria Pia Cicalese, Rohit Batta, Jonathan Appleby, Mario Davinelli, Pauline Ng
BACKGROUND: Strimvelis (autologous CD34+ cells transduced to express adenosine deaminase [ADA]) is the first ex vivo stem cell gene therapy approved by the European Medicines Agency (EMA), indicated as a single treatment for patients with ADA-severe combined immunodeficiency (ADA-SCID) who lack a suitable matched related bone marrow donor. Existing primary immunodeficiency registries are tailored to transplantation outcomes and do not capture the breadth of safety and efficacy endpoints required by the EMA for the long-term monitoring of gene therapies...
April 6, 2018: Orphanet Journal of Rare Diseases
C-M Baxter, H J Clothier, K P Perrett
Immediate hypersensitivity reactions (IHR) are rare but potentially serious adverse events following immunization (AEFI). Surveillance of Adverse Events following Vaccination in the Community (SAEFVIC) is an enhanced passive surveillance system that collects, analyses and reports information about AEFI in Victoria, Australia. We describe the incidence, timing and type of potential IHR following vaccination in preschool children reported over an 8-year period. A total of 2110 AEFI were reported in 1620 children, of which 23...
April 6, 2018: Human Vaccines & Immunotherapeutics
Megan E B Clowse, Angela E Scheuerle, Christina Chambers, Anita Afzali, Alexa B Kimball, John J Cush, Maureen Cooney, Laura Shaughnessy, Mark Vanderkelen, Frauke Förger
BACKGROUND: Anti-tumor necrosis factor medications (anti-TNFs) are effective in controlling chronic inflammatory diseases, but information about their use and safety in pregnancy is limited. Consequently, anti-TNFs are often discontinued early in gestation. Certolizumab pegol (CZP), a PEGylated, Fc-free anti-TNF approved for treatment of rheumatic diseases and/or Crohn's disease, has minimal to no active placental transfer. This project provides information on pregnancy outcomes in women receiving CZP, especially those with early pregnancy exposure...
April 5, 2018: Arthritis & Rheumatology
Yoshihiro Noguchi, Anri Ueno, Manami Otsubo, Hayato Katsuno, Ikuto Sugita, Yuta Kanematsu, Aki Yoshida, Hiroki Esaki, Tomoya Tachi, Hitomi Teramachi
BACKGROUND: Patient background (e.g. age, sex, and primary disease) is an important factor to consider when monitoring adverse drug events (ADEs) for the purpose of pharmacovigilance. However, in disproportionality methods, when additional factors are considered, the number of combinations that have to be computed increases, and it becomes very difficult to explore the whole spontaneous reporting system (SRS). Since the signals need to be detected quickly in pharmacovigilance, a simple exploration method is required...
April 5, 2018: BMC Bioinformatics
Maria J Costa, Maria T Herdeiro, Jorge J Polónia, Inês Ribeiro-Vaz, Cármen Botelho, Eunice Castro, Josefina Cernadas
Objective: Characterization of the adverse drug reactions (ADR) reported by the immunoallergology department (IAD), Centro Hospitalar de São João (Porto), to the Northern Pharmacovigilance Centre (NPC). Methods: An observational, descriptive and retrospective study was conducted, based in a spontaneous report system. Participants were all the patients from the IAD, with suspected ADR, reported to NPC by specialists after the study was completed. Results: Studied population had a median age of 41 years, with the predominance of the female gender (73...
January 2018: Pharmacy Practice
Fabrizio Schifano, Stefania Chiappini
Objective: Traditionally, studies on the non-medical use of pharmaceutical products have focused on controlled substances; e.g., opiates/opioids; and benzodiazepines. Although both bupropion and venlafaxine have been reported as being misused, only anecdotal reports have been made available so far. Hence, the European Monitoring Agency (EMA) Adverse Drug Reactions (ADRs), misuse/abuse/dependence and withdrawal, venlafaxine- and bupropion-related, database was here analyzed. Methods: All EMA spontaneous reports relating to venlafaxine (2005-2016) and bupropion (2003-2016) notifications were here analyzed, to provide a descriptive analysis by source, gender, age, and type of report...
2018: Frontiers in Pharmacology
Moza Al Hail, Wessam Elkassem, Anas Hamad, Pallivalappila Abdulrouf, Binny Thomas, Derek Stewart
Adverse Drug Reactions (ADRs) are major global concern, adversely impacting patient safety and health outcomes. ADRs cause significant morbidity and mortality among hospitalised patients, causing greater length of hospital stay, increased healthcare costs and patient dissatisfaction to the treatments. Pharmacovigilance (PV), a process of detecting, monitoring and preventing drug-related harm, plays a vital role to ensure patient safety. ADR reporting is the cornerstone of PV. PV practices in Qatar are relatively new and are evolving rapidly...
April 3, 2018: International Journal of Clinical Pharmacy
Akash Syed, Saira Azhar, Muhammad Mohsin Raza, Humaira Saeed, Shazia Qasim Jamshed
OBJECTIVES: Pharmacovigilance in Pakistan needs robust preference in terms of implementation and consistent movement of structured approaches. The objective of this study is to explore the knowledge, attitude and barriers towards adverse drug reaction (ADR) reporting among physicians and pharmacists and to explore the encouraging factors of ADR reporting. METHODS: The current research was a cross-sectional study design in which a pre-validated questionnaire was administered to physicians and pharmacists in Abbottabad, Pakistan...
March 31, 2018: Pharmacy (Basel, Switzerland)
Samy Babai, Laurent Auclert, Hervé Le-Louët
BACKGROUND AND AIM: The occurrence of drug induced liver injury (DILI) is the most common reason of post-marketing withdrawals. DILI in humans is difficult to predict using in vitro cytotoxicity screening and animal studies. A review of hepatotoxicity data was performed with the aim of identifying relevant factors that could have predicted the occurrence of serious DILI. METHODS: The drugs withdrawn from the market due to hepatotoxicity in Europe and/or in USA either by marketing authorization holders or by Regulatory agencies from 1997 to 2016 were selected...
February 21, 2018: Thérapie
Jesper Hallas, Shirley V Wang, Joshua J Gagne, Sebastian Schneeweiss, Nicole Pratt, Anton Pottegård
Active surveillance for unknown or unsuspected adverse drug effects may be carried out by applying epidemiological techniques to large administrative databases. Self-controlled designs, like the symmetry design, have the advantage over conventional design of adjusting for confounders that are stable over time. The aim of this paper was to describe the output of a comprehensive open-ended symmetry analysis of a large dataset. All drug dispensings and all secondary care contacts in Denmark during the period 1995-2012 for persons born before 1950 were analyzed by a symmetry design...
March 31, 2018: European Journal of Epidemiology
John Price
Pharmacovigilance (PV) is under unprecedented stress from fundamental changes in a booming pharmaceutical industry, from the challenges of creating and maintaining an increasingly complex PV system in a globally diverse regulatory environment, and from unpredicted consequences of historical PV cost-reduction strategies. At the same time, talent availability lags demand, and many PV professionals may no longer be finding personal fulfillment in their careers. The situation creates risks for companies. Advantages and disadvantages of potential strategies to address this increasing problem at a corporate and industry level and in collaboration with regulatory agencies are discussed, as well as opportunities to adopt new technologies, including artificial intelligence and machine-learning to automate pharmacovigilance operations...
March 28, 2018: Clinical Therapeutics
David Croteau, Charlene Flowers, Corrinne G Kulick, Allen Brinker, Cindy M Kortepeter
OBJECTIVE: To evaluate acute acalculous cholecystitis (AAC) as a potential safety risk for patients treated with alemtuzumab. METHODS: The Food and Drug Administration Adverse Event Reporting System and the medical literature were searched for cases of AAC in conjunction with alemtuzumab for all clinical indications. RESULTS: Eight spontaneously reported cases meeting the case definition of AAC in close temporal association with alemtuzumab use were identified...
March 30, 2018: Neurology
José Maria Andreas Wijnands, Feng Zhu, Elaine Kingwell, John David Fisk, Charity Evans, Ruth Ann Marrie, Yinshan Zhao, Helen Tremlett
OBJECTIVE: Little is known about disease-modifying treatments (DMTs) for multiple sclerosis (MS) and infection risk in clinical practice. We examined the association between DMTs and infection-related medical encounters. METHODS: Using population-based administrative data from British Columbia, Canada, we identified MS cases and followed them from their first demyelinating event (1996-2013) until emigration, death or study end (December 2013). Associations between DMT exposure (by DMT generation or class) and infection-related physician or hospital claims were assessed using recurrent time-to-events models, adjusted for age, sex, socioeconomic status, index year and comorbidity count...
March 30, 2018: Journal of Neurology, Neurosurgery, and Psychiatry
Swapnil Dylan Fernandes, Narayanan V Anoop, Lovely Joylen Castelino, R Narayana Charyulu
Pharmacovigilance is the pharmacological science associated with the detection, understanding and prevention of adverse effects, especially long-term and short-term adverse effects of medicines. In the present day pharmaceutical scenario, where the development and marketing of an ever-growing array of medicines has rendered their safety and therapeutic efficacy key to determining the success of a drug, pharmacovigilance has come about to play a critical and significant part. While pharmacovigilance, as a system, has witnessed considerable progress and evolution in the West, not as much has been accomplished in India...
March 23, 2018: Research in Social & Administrative Pharmacy: RSAP
K Ksouda, H Affes, A Ghorbel, L Chtourou, R Guidara, N Tahri, S Hammami, K Zeghal
Vitamin K antagonists (VKA) are difficult to use because of a narrow therapeutic index and of a marked inter- and intra-individual variability among patients in the required dosage. This drug may interact with many other drugs and same with certain food compounds. We report the case of potential interaction between soy lecithin and Vitamin K antagonists in a 46 years-old woman. Subtherapeutic INR values were detected despite the increase gradually in dose and replacing acenocoumarol by fluindione. An enquiry of pharmacovigilance was conducted found the consumption of soy lecithin capsules...
March 27, 2018: Annales de Cardiologie et D'angéiologie
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