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Pharmacoepidemiology and Drug Safety

Akeem Yusuf, Victoria Chia, Fei Xue, Daniel D Mikol, Lisa Bollinger, Charles Cangialose
PURPOSE: The recent expansion of electronic health and medical record systems may present an opportunity to generate robust post-approval safety data and obviate the limitations of prospective pregnancy exposure registries. We examined and compared, over the same time frame, the outcomes of triptan exposure in pregnancy using (1) a retrospective claims database and (2) a previously completed pregnancy registry. METHODS: Using the Marketscan database, the risk of major birth defects was ascertained in live-born infants whose birth mothers were exposed to sumatriptan, naratriptan, or sumatriptan/naproxen during pregnancy...
September 21, 2018: Pharmacoepidemiology and Drug Safety
Edward Chia-Cheng Lai, Ju-Young Shin, Kiyoshi Kubota, Kenneth K C Man, Byung Joo Park, Nicole Pratt, Elizabeth E Roughead, Ian C K Wong, Yea-Huei Kao Yang, Soko Setoguchi
PURPOSE: The safety of nonsteroidal anti-inflammatory drugs (NSAIDs) commonly used in Asia-Pacific countries has had limited study. We assessed the risk of hospitalization for gastrointestinal events with loxoprofen and mefenamic acid compared with other NSAIDs in Asia-Pacific populations. METHODS: We conducted a cohort study using a distributed network with a common data model in Australia, Hong Kong, Japan, Korea, and Taiwan. We included patients who initiated diclofenac, loxoprofen, mefenamic acid, or celecoxib and followed them until their first gastrointestinal hospitalization, switch or discontinuation of medication, disenrollment, or end of database coverage...
September 19, 2018: Pharmacoepidemiology and Drug Safety
Sara A Ephross, Allen A Mitchell, Susan Sacks, Walter Straus, Til Stürmer
No abstract text is available yet for this article.
September 19, 2018: Pharmacoepidemiology and Drug Safety
Tiantian Zhu, Yuan Zhang, Xiaofei Ye, Yongfang Hou, Jia Liu, Wentao Shi, Jinfang Xu, Xiaojing Guo, Jia He
PURPOSE: Signal evaluation is considered to be a tedious process owing to the large number of disproportional signals detected. This study aimed to apply a biclustering algorithm in the spontaneous reporting system of China and to obtain the optimal parameters. The biclustering algorithm is expected to improve the efficiency of signal evaluation by identifying similar signal groups. METHODS: Information component (IC) was the method used for disproportionality analysis...
September 19, 2018: Pharmacoepidemiology and Drug Safety
Shunsuke Ishida, Kenshi Takechi, Hiroshi Bando, Masaki Imanishi, Yoshito Zamami, Masayuki Chuma, Hiroaki Yanagawa, Yasushi Kirino, Toshimi Nakamura, Kazuhiko Teraoka, Keisuke Ishizawa
PURPOSE: Drug side effects often lead to serious outcomes. Administration of second-generation antipsychotics has resulted in diabetic ketoacidosis and diabetic coma leading to death. Therefore, pharmacists are required to collect information on clinical test values, determine the appropriate test timing, and coordinate with doctors for further clinical laboratory orders, all of which are labor-intensive and time-intensive tasks. In this study, we developed a side effect-monitoring tool and aimed to clarify the influence and efficiency of monitoring side effects by using the tool in patients taking atypical antipsychotics in whom it is necessary to check clinical test values such as blood sugar levels...
September 17, 2018: Pharmacoepidemiology and Drug Safety
Sara Fogelberg, Favelle Lamb, Olof Grönlund, Irene Eriksson, Karin Sundström, Mark Clements, Lisen Arnheim-Dahlström
PURPOSE: To investigate whether herpes zoster vaccine (HZV) was associated with socioeconomic status in Stockholm, when the vaccine was reimbursed in Sweden. METHODS: This was an observational retrospective case-control study, using population-based health care registers. During the study period, September 2013 to November 2014, the HZV was reimbursed as part of the National Pharmaceutical Benefits Scheme in Sweden and recommended for individuals over 50 years...
September 17, 2018: Pharmacoepidemiology and Drug Safety
Judy Staffa, Tamra Meyer, Alex Secora, Jana McAninch
No abstract text is available yet for this article.
September 17, 2018: Pharmacoepidemiology and Drug Safety
Mark Jones, Susan E Tett, Chris Del Mar
PURPOSE: Estimating the rate of adverse events (AEs) caused by a treatment in clinical trials typically involves comparing the proportions of patients experiencing AEs in intervention and control groups. However, potentially important information, including duration, recurrence, and intensity of events, is lost. In this study, we illustrate how the additional information can be obtained and incorporated into analyses of AEs. METHODS: Data on psychiatric AEs were extracted from clinical study reports (CSRs) provided by the manufacturer of oseltamivir in 4 prophylaxis randomised trials in adults and adolescents...
September 12, 2018: Pharmacoepidemiology and Drug Safety
Wei-Hsuan Lo-Ciganic, Julie M Donohue, Joo Yeon Kim, Elizabeth E Krans, Bobby L Jones, David Kelley, Alton E James, Marian P Jarlenski
PURPOSE: Little is known about the longitudinal patterns of buprenorphine adherence among pregnant women with opioid use disorder, especially when late initiation, nonadherence, or early discontinuation of buprenorphine during pregnancy may increase the risk of adverse outcomes. We aimed to identify distinct trajectories of buprenorphine use during pregnancy, and factors associated with these trajectories in Medicaid-enrolled pregnant women. METHODS: A retrospective cohort study included 2361 Pennsylvania Medicaid enrollees aged 15 to 46 having buprenorphine therapy during pregnancy and a live birth between 2008 and 2015...
September 7, 2018: Pharmacoepidemiology and Drug Safety
Saeko Hirota, Takuhiro Yamaguchi
PURPOSE: The purposes of the study are to compare safety specifications between Japan and the European Union (EU) and to identify the factors affecting categorization of important identified or potential risks. METHODS: Safety specifications were collected from orphan and nonorphan drugs approved in Japan between 2014 and 2016, and in the EU as of October 2017. Outcome was defined dichotomously as listed as important identified risks or potential risks. A mixed-effects logistic regression was performed to estimate odds ratios of being listed as important identified risks...
September 5, 2018: Pharmacoepidemiology and Drug Safety
Irene B Murimi, Hsien-Yen Chang, Mark Bicket, Christopher M Jones, G Caleb Alexander
PURPOSE: In October 2014, the US Drug Enforcement Agency moved hydrocodone combination products (HCPs) from schedule III to II of the Controlled Substances Act, further restricting their access. The aim of the study is to quantify the effect of hydrocodone's "upscheduling" on the use of opioid and nonopioid analgesics among chronic users. METHODS: Using IQVIA LRx LifeLink anonymized pharmacy data 2013 to 2015, we performed interrupted time series analysis and group-based trajectory modeling to characterize the effect of rescheduling on 316 731 long-term hydrocodone users...
September 5, 2018: Pharmacoepidemiology and Drug Safety
Ingrid Oosterhuis, Petra Zweers, Hans Rümke, Annemarie Muller-Hansma, Eugène Paul van Puijenbroek
PURPOSE: To estimate causation of adverse drug reaction (ADR) reports, causality methods were developed from a theoretical perspective. In daily practice, not all information is relevant or available, decreasing the applicability. We developed a new causality documentation tool (CausDoc) where an algorithm is combined with expert judgement. The aim of this study is to test the validity and reliability of CausDoc for ADR reports on drugs and vaccines. METHODS: CausDoc provides 9 structured relevant questions...
August 30, 2018: Pharmacoepidemiology and Drug Safety
Robert Ball, Sengwee Toh, Jamie Nolan, Kevin Haynes, Richard Forshee, Taxiarchis Botsis
INTRODUCTION: In May 2008, the Food and Drug Administration launched the Sentinel Initiative, a multi-year program for the establishment of a national electronic monitoring system for medical product safety that led, in 2016, to the launch of the full Sentinel System. Under the Mini-Sentinel pilot, several algorithms for identifying health outcomes of interest, including one for anaphylaxis, were developed and evaluated using data available from the Sentinel common data model. PURPOSE: To evaluate whether features extracted from unstructured narrative data using natural language processing (NLP) could be used to classify anaphylaxis cases...
August 28, 2018: Pharmacoepidemiology and Drug Safety
Jane Sterndorff Winkel, Per Damkier, Jesper Hallas, Daniel Pilsgaard Henriksen
PURPOSE: Leukotriene receptor antagonists are used in asthma and rhinitis treatment. Pharmacovigilance data have suggested an association between montelukast and depression, but the association has not been established in controlled study designs. We described the association between initiation of montelukast and depression, using prescriptions of antidepressants as a surrogate marker, and assessed whether the association was related to the underlying asthma disease. METHODS: We performed a symmetry analysis, with a study period from January 1, 2000 to December 31, 2016, using 3 nationwide Danish registers...
August 23, 2018: Pharmacoepidemiology and Drug Safety
Sinem Ezgi Gulmez, Ulku Sur Unal, Régis Lassalle, Anaïs Chartier, Adeline Grolleau, Nicholas Moore
PURPOSE: The SALT study found similar per-user risks of acute liver failure (ALF) leading to transplantation (ALFT) between NSAIDs and a threefold higher risk in nonoverdose paracetamol (NOP) users. The objective of EPIHAM was to identify the risks of hospital admission for acute liver injury (ALI) associated with NSAIDs and NOP. METHODS: Case-population study in the 1/97 sample of the French population claims database. Acute liver injury was identified from hospital discharge summaries, from 2009 to 2013...
August 16, 2018: Pharmacoepidemiology and Drug Safety
Sigal Kaplan, Earl L Goehring, Sigal Melamed-Gal, Bao-Anh Nguyen-Khoa, Helena Knebel, Judith K Jones
PURPOSE: This study examined the potential risk of cardiovascular (CV) events associated with modafinil and the consistency of the risk estimates across databases. METHODS: A retrospective, inception cohort design of patients who initiated treatment with modafinil between 2006 and 2008 was used in three US health care claims databases. Modafinil users were matched with nonusers. Patients were further divided into two cohorts of obstructive sleep apnea (OSA) and non-OSA (NOSA) cohorts...
August 14, 2018: Pharmacoepidemiology and Drug Safety
Azar Mehrabadi, Pauline Reynier, Robert W Platt, Kristian B Filion
PURPOSE: Our aim was to describe trends in the prescription of domperidone for insufficient lactation in England, the characteristics of women prescribed it postpartum, and the impact of a 2014 European Medicines Agency (EMA) recommendation to restrict its use due to a potential increased risk of sudden cardiac death associated with its use. METHODS: We conducted a population-based cohort study with interrupted time series analysis using data from the Clinical Practice Research Datalink linked to Hospital Episode Statistics...
August 14, 2018: Pharmacoepidemiology and Drug Safety
Brenda C T Kieboom, Robert Zietse, M Arfan Ikram, Ewout J Hoorn, Bruno H Stricker
PURPOSE: Hypomagnesaemia has been associated with various adverse outcomes. Loop and thiazide diuretics promote urinary magnesium excretion. However, it is unknown if this links to hypomagnesaemia. We study if loop or thiazide diuretic use affects serum magnesium levels and if it associates with hypomagnesaemia. In addition, we study the effect of combining a potassium-sparing diuretic with a thiazide diuretic on the presence of hypomagnesaemia. METHODS: The study performed a cross-sectional analysis within 9820 participants from the prospective Rotterdam Study...
August 10, 2018: Pharmacoepidemiology and Drug Safety
Junji Ikeda, Masayuki Kaneko, Mamoru Narukawa
PURPOSE: First-in-class (FIC) drugs with novel modes of action pose concerns regarding important postmarketing safety issues. The purpose of this study was to analyze the factors related to the occurrence of postmarketing safety-related regulatory actions (PSRAs) for drugs approved in the United States (US), with a focus on FIC drugs. METHODS: New molecular entities and new therapeutic biologics approved in the United States between 1 January 2003 and 31 December 2013 were included in the analysis...
August 10, 2018: Pharmacoepidemiology and Drug Safety
Hanne Birke, Ola Ekholm, Per Sjøgren, Olav Fredheim, Thomas Clausen, Svetlana Skurtveit
PURPOSE: Increasing use of tramadol for chronic non-cancer pain is concerning since tramadol users may be at risk of developing recurrent opioid use with increasing opioid consumption and co-medication. Therefore, we investigated a complete national cohort of tramadol users. METHODS: The study population (154 042 adult individuals in Norway, who redeemed ≥ one tramadol prescription in 2012) was stratified into four groups according to their opioid use 2 years before their first tramadol prescription in 2012 and followed until 2016...
August 2, 2018: Pharmacoepidemiology and Drug Safety
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