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

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https://www.readbyqxmd.com/read/28083785/erratum-to-association-between-statin-use-and-bell-s-palsy-a-population-based-study
#1
Shih-Han Hung, Li-Hsuan Wang, Herng-Ching Lin, Shiu-Dong Chung
No abstract text is available yet for this article.
January 12, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28074424/signal-detection-based-on-time-to-onset-algorithm-in-spontaneous-reporting-system-of-china
#2
Tianyi Zhang, Xiaofei Ye, Xiaojing Guo, Guizhi Wu, Yongfang Hou, Jinfang Xu, Wentao Shi, Tiantian Zhu, Yuan Zhang, Xinji Zhang, Jiaqi Song, Jia He
INTRODUCTION: The method of time-to-onset (TTO) has been proposed to overcome the drawbacks of traditional disproportionality analyses (DPAs), and it has been used for detecting safety signals of vaccines and some non-vaccine products in spontaneous reporting systems (SRSs). However, there is no consensus on its superiority over DPAs. Further, it is still not clear whether this novel approach can be generalized to the entire national SRS database. OBJECTIVE: The purpose of this study was to generalize the TTO method to the Chinese SRS and to identify suitable parameters for its optimal performance...
January 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28074423/effectiveness-of-risk-evaluation-and-mitigation-strategies-rems-for-lenalidomide-and-thalidomide-patient-comprehension-and-knowledge-retention
#3
Nancy A Brandenburg, Robert Bwire, John Freeman, Florence Houn, Paul Sheehan, Jerome B Zeldis
INTRODUCTION: The effectiveness of patient education activities conducted within the lenalidomide and thalidomide risk evaluation and mitigation strategies (REMS) programs was evaluated by measuring understanding of serious risk and safe-use messages. METHODS: Results from mandatory knowledge, attitude, and behavior surveys and voluntary patient surveys completed between June 2012 and June 2013 were analyzed, and responses to questions relating to compliance with birth control measures and understanding of safe-use messages are presented by patient risk category...
January 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28070742/authors-reply-to-jouanjus-and-colleagues-comment-on-social-media-mining-for-toxicovigilance-automatic%C3%A2-monitoring-of-prescription-medication-abuse-from-twitter
#4
LETTER
Abeed Sarker, Dan Malone, Graciela Gonzalez
No abstract text is available yet for this article.
January 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28070741/comment-on-social-media-mining-for-toxicovigilance-automatic-monitoring-of-prescription-medication-abuse-from-twitter
#5
LETTER
Emilie Jouanjus, Michel Mallaret, Joëlle Micallef, Camille Ponté, Anne Roussin, Maryse Lapeyre-Mestre
No abstract text is available yet for this article.
January 10, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28070740/generating-evidence-of-clinical-outcomes-of-drug-drug-interactions
#6
LETTER
Katsiaryna Bykov, Joshua J Gagne
No abstract text is available yet for this article.
January 9, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28044249/evaluation-of-facebook-and-twitter-monitoring-to-detect-safety-signals-for-medical-products-an-analysis-of-recent-fda-safety-alerts
#7
Carrie E Pierce, Khaled Bouri, Carol Pamer, Scott Proestel, Harold W Rodriguez, Hoa Van Le, Clark C Freifeld, John S Brownstein, Mark Walderhaug, I Ralph Edwards, Nabarun Dasgupta
INTRODUCTION: The rapid expansion of the Internet and computing power in recent years has opened up the possibility of using social media for pharmacovigilance. While this general concept has been proposed by many, central questions remain as to whether social media can provide earlier warnings for rare and serious events than traditional signal detection from spontaneous report data. OBJECTIVE: Our objective was to examine whether specific product-adverse event pairs were reported via social media before being reported to the US FDA Adverse Event Reporting System (FAERS)...
January 2, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28035492/factors-influencing-the-use-of-a-mobile-app-for-reporting-adverse-drug-reactions-and-receiving-safety-information-a-qualitative-study
#8
Sieta T de Vries, Lisa Wong, Alastair Sutcliffe, François Houÿez, Carmen Lasheras Ruiz, Peter G M Mol
INTRODUCTION: A mobile app may increase the reporting of adverse drug reactions (ADRs) and improve the communication of new drug safety information. Factors that influence the use of an app for such two-way risk communication need to be considered at the development stage. OBJECTIVE: Our aim was to reveal the factors that may influence healthcare professionals (HCPs) and patients to use an app for two-way risk communication. METHODS: Focus group discussions and face-to-face interviews were conducted in the Netherlands, Spain and the UK...
December 29, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28035491/cancer-event-rate-and-mortality-with-thienopyridines-a-systematic-review-and-meta-analysis
#9
REVIEW
Rafail Angelos Kotronias, Chun Shing Kwok, Chun Wai Wong, Tim Kinnaird, Azfar Zaman, Mamas A Mamas
INTRODUCTION: Thienopyridines are a class of antiplatelet drugs widely used in cardiovascular disease prevention and treatment. A recent concern has come to light regarding the safety of thienopyridines because of the possible risk of malignancy. We therefore performed a systematic review and meta-analysis to evaluate the association between thienopyridine exposure and malignancy. METHODS: We searched the MEDLINE and EMBASE databases in March 2016 for studies that evaluated incident cancer and cancer mortality with and without exposure to thienopyridines...
December 29, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28025733/antibiotic-induced-liver-injury-in-paediatric-outpatients-a-case-control-study-in-primary-care-databases
#10
Carmen Ferrajolo, Katia M C Verhamme, Gianluca Trifirò, Geert W 't Jong, Gino Picelli, Carlo Giaquinto, Giampiero Mazzaglia, Bruno H Stricker, Francesco Rossi, Annalisa Capuano, Miriam C J M Sturkenboom
INTRODUCTION: Antibiotics are the most commonly prescribed drug class in children. Real-world data mining on the paediatric population showed potential associations between antibiotic use and acute liver injury. OBJECTIVE: We assessed risk estimates of liver injury associated with antibiotic use in children and adolescent outpatients. METHODS: A large, multi-database, population-based, case-control study was performed in people <18 years of age from two European countries (Italy and The Netherlands) during the period 2000-2008...
December 26, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28005253/diverging-conclusions-from-the-same-meta-analysis-in-drug-safety-source-of-data-primary-versus-secondary-takes-a-toll
#11
Guillermo Prada-Ramallal, Bahi Takkouche, Adolfo Figueiras
INTRODUCTION: Meta-analyses of observational studies represent an important tool for assessing efficacy and safety in the pharmacoepidemiologic field. The data from the individual studies are either primary (i.e., collected through interviews or self-administered questionnaires) or secondary (i.e., collected from databases that were established for other purposes). So far, the origin of the data (primary vs. secondary) has not been systematically assessed as a source of heterogeneity in pharmacoepidemiologic meta-analyses...
December 22, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28000151/the-impact-of-provider-networks-on-the-co-prescriptions-of-interacting-drugs-a-claims-based-analysis
#12
Mei-Sing Ong, Karen L Olson, Laura Chadwick, Chunfu Liu, Kenneth D Mandl
INTRODUCTION: Multiple provider prescribing of interacting drugs is a preventable cause of morbidity and mortality, and fragmented care is a major contributing factor. We applied social network analysis to examine the impact of provider patient-sharing networks on the risk of multiple provider prescribing of interacting drugs. METHODS: We performed a retrospective analysis of commercial healthcare claims (years 2008-2011), including all non-elderly adult beneficiaries (n = 88,494) and their constellation of care providers...
December 20, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27995520/effect-of-medications-for-gastric-acid-related-symptoms-on-total-motile-sperm-count-and-concentration-a-case-control-study-in-men-of-subfertile-couples-from-the-netherlands
#13
Nicole A Huijgen, Hedwig J Goijen, John M Twigt, Annemarie G M G J Mulders, Jan Lindemans, Gert R Dohle, Joop S E Laven, Régine P M Steegers-Theunissen
INTRODUCTION: Gastric acid-related symptoms are highly prevalent in the general population (21-40%), and more than 11% of individuals use medication for the treatment of these symptoms. The uptake of micronutrients is dependent on the gastrointestinal potential of hydrogen (pH). OBJECTIVE: We hypothesized that medication affecting gastrointestinal pH reduces the availability of B vitamins, thereby deranging one-carbon metabolism and detrimentally affecting spermatogenesis...
December 19, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27995519/hepatic-cyst-infection-during-use-of-the-somatostatin-analog-lanreotide-in-autosomal-dominant-polycystic-kidney-disease-an-interim-analysis-of-the-randomized-open-label-multicenter-dipak-1-study
#14
Marten A Lantinga, Hedwig M A D'Agnolo, Niek F Casteleijn, Johan W de Fijter, Esther Meijer, Annemarie L Messchendorp, Dorien J M Peters, Mahdi Salih, Edwin M Spithoven, Darius Soonawala, Folkert W Visser, Jack F M Wetzels, Robert Zietse, Joost P H Drenth, Ron T Gansevoort
INTRODUCTION AND AIMS: The DIPAK-1 Study investigates the reno- and hepatoprotective efficacy of the somatostatin analog lanreotide compared with standard care in patients with later stage autosomal dominant polycystic kidney disease (ADPKD). During this trial, we witnessed several episodes of hepatic cyst infection, all during lanreotide treatment. We describe these events and provide a review of the literature. METHODS: The DIPAK-1 Study is an ongoing investigator-driven, randomized, controlled, open-label multicenter trial...
December 19, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27988884/proactive-regional-pharmacovigilance-system-versus-national-spontaneous-reporting-for-collecting-safety-data-on-concerning-off-label-prescribing-practices-an-example-with-baclofen-and-alcohol-dependence-in-france
#15
Marine Auffret, Julien Labreuche, Alain Duhamel, Sylvie Deheul, Olivier Cottencin, Régis Bordet, Sophie Gautier, Benjamin Rolland
INTRODUCTION: Off-label prescribing (OLP) may raise serious safety concerns that traditional spontaneous reporting of adverse drug reactions (ADRs) may not identify in a timely manner. In France, the 'Multidisciplinary Consultation Service for Off-Label Prescribing in Addiction Medicine' (CAMTEA) is a proactive regional system established to identify ADRs associated with the OLP of baclofen for alcohol dependence. OBJECTIVE: The aim was to demonstrate, using the French pharmacovigilance database (FPVD), that CAMTEA allowed for the reporting of a substantial amount of ADRs, comparable in nature to those provided via spontaneous reporting...
December 17, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27988883/surveillance-of-adverse-events-after-seasonal-influenza-vaccination-in-pregnant-women-and-their-infants-in-the-vaccine-adverse-event-reporting-system-july-2010-may-2016
#16
Pedro Moro, Jane Baumblatt, Paige Lewis, Janet Cragan, Naomi Tepper, Maria Cano
INTRODUCTION: Routine immunization of pregnant women with seasonal inactivated influenza vaccines (IIVs) is recommended in all trimesters of pregnancy. A review of the Vaccine Adverse Event Reporting System (VAERS) during 1990-2009 did not find any unexpected patterns of pregnancy complications or fetal outcomes after administration of IIV or live attenuated influenza vaccines (LAIVs). During the 2009-2010 pandemic influenza A (H1N1) vaccination campaign, a study noted that the number of VAERS reports from pregnant women who received the H1N1 2009 inactivated monovalent vaccine (n = 288) increased compared with 1990-2009 seasonal IIV pregnancy reports (n = 148)...
December 17, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27981444/hyperglycaemia-induced-by-novel-anticancer-agents-an-undesirable-complication-or-a-potential-therapeutic-opportunity
#17
REVIEW
Rashmi R Shah
Signalling pathways involving protein kinase, insulin-like growth factor 1, insulin receptors and the phosphoinositide 3 kinase/protein kinase B/mammalian target of rapamycin (PI3K/AKT/mTOR) system are critical in promoting oncogenesis. The use of anticancer agents that inhibit these pathways frequently results in hyperglycaemia, an on-target effect of these drugs. Hyperglycaemia induced by these agents denotes optimal inhibition of the desired pharmacological target. As hyperglycaemia can be treated successfully and effectively with metformin, managing this complication by reducing the dose of or discontinuing the anticancer drug may be counterproductive, especially if it is otherwise effective and clinically tolerated...
December 15, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27943160/melanoma-and-non-melanoma-skin-cancer-associated-with-angiotensin-converting-enzyme-inhibitors-angiotensin-receptor-blockers-and-thiazides-a-matched-cohort-study
#18
Beatrice Nardone, Sara Majewski, Ashley S Kim, Tina Kiguradze, Estela M Martinez-Escala, Rivka Friedland, Ahmad Amin, Anne E Laumann, Beatrice J Edwards, Alfred W Rademaker, Mary C Martini, Dennis P West
INTRODUCTION: Controversy exists about an association between angiotensin-converting-enzyme inhibitors (ACEIs), angiotensin-receptor blockers (ARBs), and thiazides (TZs) and the risk of malignant melanoma (MM), and non-melanoma skin cancer-basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). OBJECTIVE: The aim of this study was to determine if an association exists for ACEI, ARB, or TZ exposure and skin cancers. METHODS: This was a matched cohort study using a large electronic medical records repository, the Northwestern Medicine Enterprise Data Warehouse (NMEDW)...
December 9, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27928727/benefits-and-risks-of-long-term-asthma-management-in-children-where-are-we-heading
#19
Hengameh H Raissy, H William Kelly
International guidelines provide recommendations for a stepwise approach to the management of asthma in children 0-4 years old, 5-11 years old, and adolescents who are treated as adults. Therapy is aimed at two domains of control: current impairment and future risk. The long-term controller medications, inhaled corticosteroids (ICSs), ICSs in combination with long-acting β2 agonists, leukotriene receptor antagonists, and immunomodulators, exhibit different efficacies for these domains. The risk:benefit ratios of the available medications need to be carefully assessed...
December 7, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/27928726/evaluating-the-safety-profile-of-non-active-implantable-medical-devices-compared-with-medicines
#20
REVIEW
Josep Pane, Preciosa M Coloma, Katia M C Verhamme, Miriam C J M Sturkenboom, Irene Rebollo
Recent safety issues involving non-active implantable medical devices (NAIMDs) have highlighted the need for better pre-market and post-market evaluation. Some stakeholders have argued that certain features of medicine safety evaluation should also be applied to medical devices. Our objectives were to compare the current processes and methodologies for the assessment of NAIMD safety profiles with those for medicines, identify potential gaps, and make recommendations for the adoption of new methodologies for the ongoing benefit-risk monitoring of these devices throughout their entire life cycle...
December 7, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
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