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Pharmacovigilence

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https://www.readbyqxmd.com/read/29339968/analysis-of-questions-about-use-of-drugs-in-breastfeeding-to-norwegian-drug-information-centres
#1
Jan Anker Jahnsen, Sofia Frost Widnes, Jan Schjøtt
Background: Health professionals may advise women to either stop breastfeeding or drug treatment due to restrictive advice in drug monographs. Regional medicines information and pharmacovigilance centres in Norway (RELIS) provide free and industry-independent answers to questions about drugs and breastfeeding documented in a full-text, searchable database (RELIS database). We used the RELIS database to describe which health care practitioners sought information about medication safety in lactation, most common drugs involved, advice provided and which resources were used to provide the advice...
2018: International Breastfeeding Journal
https://www.readbyqxmd.com/read/29339434/cerebrovascular-outcomes-with-proton-pump-inhibitors-and-thienopyridines-a-systematic-review-and-meta-analysis
#2
Konark Malhotra, Aristeidis H Katsanos, Mohammad Bilal, Muhammad Fawad Ishfaq, Nitin Goyal, Georgios Tsivgoulis
BACKGROUND AND PURPOSE: Pharmacokinetic and prior studies on thienopyridine and proton pump inhibitors (PPI) coadministration provide conflicting data for cardiovascular outcomes, whereas there is no established evidence on the association of concomitant use of PPI and thienopyridines with adverse cerebrovascular outcomes. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials and cohort studies from inception to July 2017, reporting following outcomes among patients treated with thienopyridine and PPI versus thienopyridine alone (1) ischemic stroke, (2) combined ischemic or hemorrhagic stroke, (3) composite outcome of stroke, myocardial infarction (MI), and cardiovascular death, (4) MI, (5) all-cause mortality, and (6) major or minor bleeding events...
January 16, 2018: Stroke; a Journal of Cerebral Circulation
https://www.readbyqxmd.com/read/29337457/-pharmacovigilance-update
#3
Françoise Livio
The main pharmacovigilance updates in 2017 are reviewed. Denosumab : rebound-associated multiple vertebral fractures after discontinuation. Canagliflozine: increased risk of foot/leg amputations. Biologic and targeted cancer therapies, direct-acting antivirals for chronic hepatitis C: risk of hepatitis B reactivation. Checkpoint inhibitors : immune-related adverse events and graft rejection. Fingolimod : rebound-associated reactivation of MS following withdrawal. Daclizumab: risk of severe liver injury leading to restricted use in MS patients...
January 10, 2018: Revue Médicale Suisse
https://www.readbyqxmd.com/read/29335823/-drugs-for-intravenous-induction-of-anesthesia-propofol
#4
D Bolkenius, C Dumps, E Halbeck
In a series of articles dealing with hypnotics for induction of anesthesia, this article describes the development and current value of propofol. Its significance far exceeds that of a pure induction hypnotic (sedation in diagnostic and therapeutic procedures and on the intensive care unit). Propofol is also used for sedation in diagnostic and therapeutic procedures and on the intensive care unit. In the field of induction of anesthesia, the alternatives are barely used. Some contraindications are still controversial whereas others are no longer sufficiently anchored in the users' awareness (widespread off-label use)...
January 15, 2018: Der Anaesthesist
https://www.readbyqxmd.com/read/29329993/pulmonary-arterial-hypertension-in-four-patients-treated-by-leflunomide
#5
Valentin Coirier, Alain Lescoat, Céline Chabanne, Maxime Fournet, Guillaume Coiffier, Stéphane Jouneau, Elisabeth Polard, Patrick Jégo
Pulmonary arterial hypertension (PAH) is a rare disorder that can be drug-induced, mostly following treatment by appetite-suppressant drugs. We report four cases of patients who developed PAH following a treatment by leflunomide for rheumatoid arthritis, psoriatic arthritis or undetermined connective tissue disease. All patients described a progressive dyspnea from grade II to IV of NYHA classification; clinical examination found signs of heart failure. PAH was finally diagnosed and confirmed by right heart catheterisation...
January 9, 2018: Joint, Bone, Spine: Revue du Rhumatisme
https://www.readbyqxmd.com/read/29327451/strengthening-standards-transparency-and-collaboration-to-support-medicine-evaluation-ten-years-of-the-european-network-of-centres-for-pharmacoepidemiology-and-pharmacovigilance-encepp
#6
Xavier Kurz, Susana Perez-Gutthann
No abstract text is available yet for this article.
January 11, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29325166/drug-safety-and-immunogenicity-of-tumour-necrosis-factor-inhibitors-the-story-so-far
#7
Meghna Jani, William G Dixon, Hector Chinoy
TNF-α inhibitor (TNFi) therapies have transformed the treatment of several rheumatic musculoskeletal diseases. However, the majority of TNFi's are immunogenic and consequent anti-drug antibodies formation can impact on both treatment efficacy and safety. Several controversies exist in the area of immunogenicity of TNFis and drug safety. While anti-drug antibodies to TNFis have been described in association with infusion reactions; serious adverse events (AEs) such as thromboembolic events, lupus-like syndrome, paradoxical AEs, for example, vasculitis-like events and other autoimmune manifestations have also been reported...
January 8, 2018: Rheumatology
https://www.readbyqxmd.com/read/29324463/fractures-related-to-tenofovir-a-case-noncase-study-in-the-european-pharmacovigilance-database
#8
Montserrat G García, Unai Larrinaga-Torrontegui, Eduardo Eduardo Martinez, Unax Lertxundi, Itziar Palacios-Zabalza, Carmelo Aguirre
BACKGROUND: There is no clear consensus on the relationship between tenofovir (TDF) and fracture risk because the studies published so far present contradictory findings. STUDY QUESTION: Our objective was to detect, from the European pharmacovigilance database (EudraVigilance), a signal of fracture risk during TDF exposure in patients infected with HIV. METHODS: Herein, we analyze all the cases of fractures suspected to be related to TDF recorded in EudraVigilance between 2001 and November 10, 2016...
January 8, 2018: American Journal of Therapeutics
https://www.readbyqxmd.com/read/29322474/pharmacovigilance-in-developing-countries-part-ii-a-path-forward
#9
Shaimaa Elshafie, Anne Marie Roberti, Iman Zaghloul
In recent years, attention to pharmacovigilance has gained momentum in developing countries, however awareness of, and policies or systems for pharmacovigilance in most developing countries still lags sharply behind developed countries. This article proposes different strategies to encourage the introduction and sustain the advancement of robust pharmacovigilance systems in developing countries. To this end, this article seeks to accomplish the ultimate goal of pharmacovigilance in a developing country context; ensuring patient safety and promoting safe and rational use of drugs...
January 10, 2018: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/29318002/the-hope-hype-and-reality-of-big-data-for-pharmacovigilance
#10
EDITORIAL
Andrew Bate, Robert F Reynolds, Patrick Caubel
No abstract text is available yet for this article.
January 2018: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/29315721/do-final-year-medical-students-have-sufficient-prescribing-competencies-a-systematic-literature-review
#11
David J Brinkman, Jelle Tichelaar, Sanne Graaf, René H J Otten, Milan C Richir, Michiel A van Agtmael
AIMS: Prescribing errors are an important cause of patient safety incidents and are frequently caused by junior doctors. This might be because the prescribing competence of final-year medical students is poor as a result of inadequate clinical pharmacology and therapeutic (CPT) education. We reviewed the literature to investigate which prescribing competencies medical students should have acquired in order to prescribe safely and effectively, and whether these have been attained by the time they graduate...
January 8, 2018: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29314262/adverse-drug-reactions-of-analgesic-medicines-analysis-of-the-romanian-pharmacovigilance-database
#12
Irina Cazacu, Roxana Stroe, Roxana Dondera, Cristina Mogosan, Françoise Haramburu, Annie Fourrier-Réglat, Felicia Loghin
The results of national safety studies are essential for decision-making at the regulatory level and have also educational implications for prescribing patterns. The aim of the present study was to analyze the ADRs of analgesic medicines spontaneously reported to Pharmacovigilance and Risk Management Service of the Romanian National Agency for Medicines and Medical Devices between 2011 and 2015. For the 71 reports, patients had a mean age of 39.8 years; 60.6% of patients were female, 38% male and 1.4% were unknown...
January 4, 2018: Fundamental & Clinical Pharmacology
https://www.readbyqxmd.com/read/29278532/risks-of-cardiovascular-or-central-nervous-system-adverse-events-and-immune-reconstitution-inflammatory-syndrome-for-dolutegravir-versus-other-antiretrovirals-meta-analysis-of-randomized-trials
#13
Andrew M Hill, Nikkita Mitchell, Sophie Hughes, Anton L Pozniak
PURPOSE OF REVIEW: Results from nonrandomized cohort studies suggest higher risks of CNS adverse events for dolutegravir, versus other ARVs. There have been two case reports of myocarditis on dolutegravir. Integrase inhibitors have been associated with IRIS in two cohort studies. Meta-analysis of randomized trials can be used to cross-check potential safety signals. This systematic review of drug safety used an EMBASE and MEDLINE search combined with serious adverse event (SAE) reports on the website www...
December 22, 2017: Current Opinion in HIV and AIDS
https://www.readbyqxmd.com/read/29275134/comparative-safety-of-drugs-targeting-the-nitric-oxide-pathway-in-pulmonary-hypertension-a-mixed-approach-combining-a-meta-analysis-of-clinical-trials-and-a-disproportionality-analysis-from-the-who-pharmacovigilance-database
#14
C Khouri, M Lepelley, M Roustit, F Montastruc, M Humbert, J L Cracowski
BACKGROUND: Recent guidelines recommend riociguat, a soluble guanylate cyclase (sGC) stimulator, as well as the type 5 phosphodiesterase inhibitor (PDE5i) tadalafil or sildenafil as treatments for pulmonary arterial hypertension. We compared the safety profiles of sildenafil, tadalafil and riociguat in pulmonary hypertension. METHODS: We combined two approaches: First, we performed a meta-analysis of safety data extracted from randomized controlled trials. Secondly, we conducted a disproportionality analysis of data from VigiBase, the WHO global database of individual case safety reports, to compare the safety profiles with real life data...
December 21, 2017: Chest
https://www.readbyqxmd.com/read/29274824/antituberculosis-drug-associated-dress-a-case-series
#15
Marion Allouchery, Sophie Logerot, Judith Cottin, Pauline Pralong, Céline Villier, Benoit Ben Saïd
BACKGROUND: Although antituberculosis drug-associated drug reaction with eosinophilia and systemic symptoms (DRESS) is rarely reported, its diagnosis should not be dismissed. Its management implies an early withdrawal of suspected drugs. OBJECTIVE: The objective of this study was to describe the characteristics of antituberculosis drug-associated DRESS and to identify the most likely involved drugs. METHODS: We searched for potential cases of DRESS with rifampicin, isoniazid, pyrazinamide, and ethambutol reported from January 1, 2005, to July 30, 2015, in the French pharmacovigilance database...
December 20, 2017: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/29258401/preventable-adrs-leading-to-hospitalization-results-of-a-long-term-prospective-safety-study-with-6-427-adr-cases-focusing-on-elderly-patients
#16
S Schmiedl, M Rottenkolber, J Szymanski, B Drewelow, W Siegmund, M Hippius, K Farker, I R Guenther, J Hasford, P A Thuermann
BACKGROUND: Studies evaluating the impact of age and potentially inappropriate medication (PIM) on avoidable adverse drug reactions (ADRs) are scarce. METHODS: In this prospective, multi-center, long-term (8.5 years) observational study, we analysed ADRs leading to hospitalization in departments of internal medicine. ADRs causality and preventability were assessed using standardised algorithms. PIM was defined based on the PRISCUS-list. Multivariate analyses and estimation of ADR incidence rates were conducted...
February 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29248988/pharmacovigilance-in-developing-countries-part-i-importance-and-challenges
#17
Shaimaa Elshafie, Iman Zaghloul, Anne Marie Roberti
The thalidomide disaster was the significant historical event that acted as a catalyst for pharmacovigilance activity. Following this event developed countries initiated drug monitoring systems that evolved and now extend their scope to broader drug-related safety issues; however, this was not the case in developing countries. Pharmacovigilance is still a relatively new concept with low priority in developing countries although various issues are raising concerns that magnify the need for systems to monitor post marketing drug safety in these countries...
December 16, 2017: International Journal of Clinical Pharmacy
https://www.readbyqxmd.com/read/29248119/-hyponatremia-associated-with-ssri-nrsi-descriptive-and-comparative-epidemiological-study-of-the-incidence-rates-of-the-notified-cases-from-the-data-of-the-french-national-pharmacovigilance-database-and-the-french-national-health-insurance
#18
https://www.readbyqxmd.com/read/29233304/perspective-of-saudi-undergraduate-pharmacy-students-on-pharmacovigilance-and-adverse-drug-reaction-reporting-a-national-survey
#19
Nazmeyah Alkayyal, Ejaz Cheema, Muhammad Abdul Hadi
INTRODUCTION: The purpose of this study was to evaluate Saudi undergraduate pharmacy students' knowledge, attitude, and readiness towards pharmacovigilance and reporting of adverse drug reactions (ADRs). METHODS: A cross-sectional survey was conducted between January 15, 2016 and February 18, 2016 using a structured, validated and pilot-tested questionnaire among senior (year 4, 5, and 6) undergraduate pharmacy students enrolled at a governmental or private university/college...
September 2017: Currents in Pharmacy Teaching & Learning
https://www.readbyqxmd.com/read/29227893/targeted-eco-pharmacovigilance-for-ketoprofen-in-the-environment-need-strategy-and-challenge
#20
REVIEW
Jun Wang, Shu-Qi Zhao, Meng-Ya Zhang, Bing-Shu He
Implementing "targeted" eco-pharmacovigilance(EPV) which focuses on individual or specific pharmaceuticals on a prioritised basis is a feasible, economical and customized approach to reduce the environmental concentrations and risks of pharmaceuticals. Non-steroidal anti-inflammatory drugs(NSAIDs) remaining in environment are a kind of priority hazard substances, due to a notable case that diclofenac residues caused the loss of more than 99% of vultures across the Indian sub-continent. Ketoprofen, as another widely used NSAID with comparable or even higher global consumption than diclofenac, in the environment has been shown to present a potential risk to non-target terrestrial and aquatic species...
December 6, 2017: Chemosphere
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