Signal detection for vaccine side effects that have not been specified in advance.

abstract：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 depres...

journal_title：Pharmacoepidemiology and drug safety

authors： Winkel JS,Damkier P,Hallas J,Henriksen DP

更新日期：2018-12-01 00:00:00

abstract：PURPOSE:To characterize the nature of a heparin contaminant's clinical effects in cases reported to the Adverse Event Reporting System (AERS). The FDA received reports of heparin-associated adverse events (AEs) starting in late 2007-early 2008 during a national investigation of allergic-type events. The investigation i...

journal_title：Pharmacoepidemiology and drug safety

authors： McMahon AW,Pratt RG,Hammad TA,Kozlowski S,Zhou E,Lu S,Kulick CG,Mallick T,Dal Pan G

更新日期：2010-09-01 00:00:00

abstract：PURPOSE:To validate the recorded diagnoses of colorectal cancer (CRC) and identify false negatives in The Health Improvement Network (THIN) primary care database. METHODS:We conducted a validation study of incident CRC cases in THIN among patients aged 40-89 years from 2000-2011. CRC Read code entries (N = 3805) were ...

journal_title：Pharmacoepidemiology and drug safety

authors： Cea Soriano L,Soriano-Gabarró M,García Rodríguez LA

更新日期：2016-04-01 00:00:00

abstract：:A series of case reports to the varicella vaccine Pregnancy Registry described inadvertent administrations during pregnancy of this live virus product instead of the intended Varicella zoster immune globulin. Cases continued to accrue despite an early publication about the pattern. The persistent problem warrants spec...

journal_title：Pharmacoepidemiology and drug safety

authors： Wise RP,Braun MM,Seward JF,Mootrey GT,Shields KE,Salive ME,Krause PR

更新日期：2002-12-01 00:00:00

abstract：BACKGROUND:Poor-quality patient drug information has been identified as a major cause of preventable medication errors in the United States. The US Food and Drug Administration (FDA) has the authority to require marketing authorization holders of medicinal products to implement risk evaluation and mitigation strategies...

journal_title：Pharmacoepidemiology and drug safety

authors： Chan HW,Russell AM,Smith MY

更新日期：2018-09-01 00:00:00

abstract：OBJECTIVES:This study quantifies the incidence of liver enzyme abnormalities in the general population of central Massachusetts. METHODS:Computerized data files from a health maintenance organization were used to ascertain potential subjects during the study period of 1 July 1992-30 June 1993. Medical records and labo...

journal_title：Pharmacoepidemiology and drug safety

authors： Duh MS,Walker AM,Kronlund KH Jr

更新日期：1999-07-01 00:00:00

abstract：PURPOSE:Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive-reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evaluation. As a consequen...

journal_title：Pharmacoepidemiology and drug safety

authors： Pane J,Francisca RDC,Verhamme KMC,Orozco M,Viroux H,Rebollo I,Sturkenboom MCJM

更新日期：2019-09-01 00:00:00

abstract：PURPOSE:The Vaccine Safety Datalink (VSD) Project conducts near real-time vaccine safety surveillance using sequential analytic methods. Timely surveillance is critical in identifying potential safety problems and preventing additional exposure before most vaccines are administered. For vaccines that are administered d...

journal_title：Pharmacoepidemiology and drug safety

authors： Greene SK,Kulldorff M,Yin R,Yih WK,Lieu TA,Weintraub ES,Lee GM

更新日期：2011-06-01 00:00:00

abstract：BACKGROUND:Deferasirox (DFX) is an effective and well-tolerated oral iron chelator elevating the adherence to iron chelating therapy among patients with iron overload. However, the US Food and Drug Administration issued a warning about the potential adverse events associated with DFX in 2010. METHODS:To examine the ri...

journal_title：Pharmacoepidemiology and drug safety

authors： Huang WF,Chou HC,Tsai YW,Hsiao FY

更新日期：2014-11-01 00:00:00

abstract：PURPOSE:Our objective was to examine the numbers and characteristics of US pediatric adverse events (AEs) reported to the Food and Drug Administration (FDA)'s adverse event reporting system (AERS) for 5 years following implementation of the Best Pharmaceuticals for Children Act (BPCA) in 2002. METHODS:We analyzed repo...

journal_title：Pharmacoepidemiology and drug safety

authors： Johann-Liang R,Wyeth J,Chen M,Cope JU

更新日期：2009-01-01 00:00:00

abstract：PURPOSE:Stimulant medications used for treating attention deficit hyperactivity disorder (ADHD) can be associated with an increased risk of seizures. Atomoxetine is a non-stimulant medication approved for treating ADHD. This retrospective cohort analysis evaluated risk of seizures among pediatric patients naïve to ADHD...

journal_title：Pharmacoepidemiology and drug safety

authors： McAfee AT,Landon J,Jones M,Bangs ME,Acharya N,Hornbuckle K,Wong J

更新日期：2013-04-01 00:00:00

abstract：PURPOSE:We review statistical methods for assessing the possible impact of bias due to unmeasured confounding in real world data analysis and provide detailed recommendations for choosing among the methods. METHODS:By updating an earlier systematic review, we summarize modern statistical best practices for evaluating ...

journal_title：Pharmacoepidemiology and drug safety

authors： Zhang X,Stamey JD,Mathur MB

更新日期：2020-10-01 00:00:00

abstract：PURPOSE:Use of albumin (indications and quantities involved) has not been assessed in France since major changes occurred after the publication of Cochrane group meta-analysis. The objectives of this study were to measure the repartition of albumin indications in three French university hospitals in 2004 and to assess ...

journal_title：Pharmacoepidemiology and drug safety

authors： Pradel V,Tardieu S,Micallef J,Signoret A,Villano P,Gauthier L,Vanelle P,Blin O,Albumin Study Group.

更新日期：2007-01-01 00:00:00

abstract：PURPOSE:To estimate 1-year prevalence, 1-year incidence and indication of use of antidepressant (AD) drug treatment in general practice of Southern Italy during the years 2003-2004. METHODS:Among 142,346 individuals registered in the lists of 119 general practitioners of Southern Italy, we identified users of differen...

journal_title：Pharmacoepidemiology and drug safety

authors： Trifirò G,Barbui C,Spina E,Moretti S,Tari M,Alacqua M,Caputi AP,UVEC group.,Arcoraci V

更新日期：2007-05-01 00:00:00

abstract：PURPOSE:Nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with severe renal complications, including acute renal failure, reduced glomerular filtration rate and interstitial nephritis. Caution against NSAIDs is therefore recommended in advanced chronic kidney disease. In this study, we examined NSAID use,...

journal_title：Pharmacoepidemiology and drug safety

authors： Kristensen SL,Fosbøl EL,Kamper AL,Køber L,Hommel K,Lamberts M,Abildstrøm SZ,Blicher TM,Torp-Pedersen C,Gislason GH

更新日期：2012-04-01 00:00:00

abstract：:We review the concept of time-dependent confounding by using the example in paper "Comparative effectiveness of individual angiotensin receptor blockers on risk of mortality in patients with chronic heart failure" by Desai et al. and illustrate how to adjust for it by using inverse probability of treatment weighting t...

journal_title：Pharmacoepidemiology and drug safety

authors： Yang W,Joffe MM

更新日期：2012-03-01 00:00:00

abstract：PURPOSE:The aims of the present study were to evaluate the use of drugs with anticholinergic properties in elderly patients and to identify risk factors that increase the patient's chance of being given such medications. METHODS:The study was performed on a sample of 1636 patients aged ≥65 years hospitalised during th...

journal_title：Pharmacoepidemiology and drug safety

authors： Wawruch M,Macugova A,Kostkova L,Luha J,Dukat A,Murin J,Drobna V,Wilton L,Kuzelova M

更新日期：2012-02-01 00:00:00

abstract：PURPOSE:Economic factors, market dynamics, and safety issues are largely responsible for decisions to withdraw pharmaceutical products from the market. In this study, new molecular entities (NMEs) approved by the Food and Drug Administration (FDA) were examined in the USA from 1980 to 2009. METHODS:Data were obtained ...

journal_title：Pharmacoepidemiology and drug safety

authors： Qureshi ZP,Seoane-Vazquez E,Rodriguez-Monguio R,Stevenson KB,Szeinbach SL

更新日期：2011-07-01 00:00:00

abstract：:Schizophrenia is a life-threatening disease associated with mortality rates that are two to three times higher than those expected/observed in the general population. It is associated with high levels of suicide, particularly in young male patients soon after diagnosis. Delays in treating schizophrenia could contribut...

journal_title：Pharmacoepidemiology and drug safety

authors： Auquier P,Lançon C,Rouillon F,Lader M

更新日期：2007-12-01 00:00:00

abstract：PURPOSE:Three recent observational studies reported that the risk of fatal overdose is greater with venlafaxine than SSRI use. It is not clear whether patient factors could account for this finding. We evaluated whether risk factors for suicide are more prevalent among patients prescribed venlafaxine than patients pres...

journal_title：Pharmacoepidemiology and drug safety

authors： Mines D,Hill D,Yu H,Novelli L

更新日期：2005-06-01 00:00:00

abstract：PURPOSE:Our objectives were to determine performance of coded hyperkalemia diagnosis at identifying (1) clinically evident hyperkalemia and (2) serum potassium>6 mmol/L. METHODS:This retrospective observational study included 8722 patients with diabetes within an integrated healthcare system who newly initiated an ang...

journal_title：Pharmacoepidemiology and drug safety

authors： Raebel MA,Smith ML,Saylor G,Wright LA,Cheetham C,Blanchette CM,Xu S

更新日期：2010-11-01 00:00:00

abstract：PURPOSE:Increased post-marketing reports of 'interstitial pneumonia' as an adverse drug reaction (ADR) from the use of gefitinib, irinotecan, or leflunomide among patients in Japan have not been noted in other countries. The WHO International Drug Monitoring Database was analyzed to examine Japan's pattern of reporting...

journal_title：Pharmacoepidemiology and drug safety

authors： Koo LC,Clark JA,Quesenberry CP,Higenbottam T,Nyberg F,Wolf MK,Steinberg MH,Forsythe BH

更新日期：2005-11-01 00:00:00

abstract：PURPOSE:Although sales of prescribed and over-the-counter (OTC) medication are rising, little is known about individual drug intake. This study was aimed to obtain complementary information about drug intake. METHOD:Information on drug utilization was obtained in a female cohort for five different time points (TP): 36...

journal_title：Pharmacoepidemiology and drug safety

authors： Hoeke H,Roeder S,Bertsche T,Borte M,von Bergen M,Wissenbach DK

更新日期：2016-04-01 00:00:00

abstract：PURPOSE:The aim of this study was to evaluate the effect of the length of the drug free period on incidence measurements as well as on cohort characteristics in users of antidepressants. METHODS:The study population consisted of patients aged 18 years or older who filled a prescription for an antidepressant drug in th...

journal_title：Pharmacoepidemiology and drug safety

authors： Gardarsdottir H,Heerdink ER,Egberts AC

更新日期：2006-05-01 00:00:00

abstract：PURPOSE:Fear of discontinuing concomitant anti-epileptic drugs (AEDs) may lead to potentially unnecessary and perhaps unsafe polypharmacy. The effect of withdrawing concomitant AEDs on epilepsy control was therefore studied in long-term users of levetiracetam. METHODS:The EULEV cohort followed patients initiating leve...

journal_title：Pharmacoepidemiology and drug safety

authors： Droz-Perroteau C,Marchal C,Dureau-Pournin C,Lassalle R,Jové J,Robinson P,Lavernhe G,Vespignani H,Moore N,Fourrier-Réglat A,Eulev Study Group.

更新日期：2012-11-01 00:00:00

abstract：PURPOSE:To study patterns of antiepileptic drugs (AED) prescribing, particularly valproate, during pregnancy over a 10-year period in the UK, Italy, and France. METHODS:Data on pregnancies conceived after 1 January 2007 with outcomes before 31 December 2016 were extracted from four European electronic health care data...

journal_title：Pharmacoepidemiology and drug safety

authors： Hurault-Delarue C,Morris JK,Charlton R,Gini R,Loane M,Pierini A,Puccini A,Neville A,Snowball J,Damase-Michel C,EUROmediSAFE consortium.

更新日期：2019-11-01 00:00:00

abstract：BACKGROUND AND AIMS:Epidemiologic studies on a potential chemopreventive effect of statin therapy have yielded conflicting results. We sought to clarify whether long-term statin therapy has a chemopreventive effect on the risk of colorectal cancer (CRC) in a large, population-representative cohort. METHODS:A nested ca...

journal_title：Pharmacoepidemiology and drug safety

authors： Yang YX,Hennessy S,Propert K,Hwang WT,Sarkar M,Lewis JD

更新日期：2008-09-01 00:00:00

abstract：PURPOSE:Evidence is growing that early use of disease-modifying anti-rheumatic drugs (DMARDs) and combinations of these drugs provide optimal care for people with rheumatoid arthirits. The aim of this study was to describe objectively the pattern of consumption of DMARDs in the Australian community (community-based pre...

journal_title：Pharmacoepidemiology and drug safety

authors： Chan V,Tett SE

更新日期：2006-07-01 00:00:00

abstract：PURPOSE:Although a series of serious adverse events have continually raised concerns about the potential toxicity of traditional Chinese medicine injections (TCM injections), studies on this subject are still sparse. We conducted a descriptive analysis of a spontaneous reporting system in China to describe the safety p...

journal_title：Pharmacoepidemiology and drug safety

authors： Li H,Deng J,Deng L,Ren X,Xia J

更新日期：2019-07-01 00:00:00

abstract：PURPOSE:In pharmacoepidemiology, one of the main concerns is analysis of drug exposure time. However, in real-life settings, patient's behavior is complex and characterized by drug exposure dynamics. Multi-state models allow assessing the probabilities of various patterns, instead of just continuous use and/or disconti...

journal_title：Pharmacoepidemiology and drug safety

authors： Boucherie Q,Pauly V,Frauger E,Thirion X,Pradel V,Micallef J

更新日期：2015-09-01 00:00:00