abstract：INTRODUCTION:Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. METHODS:Three major types of EHDs in China (i.e., a regional commu...

journal_title：Drug safety

authors： Yang Y,Zhou X,Gao S,Lin H,Xie Y,Feng Y,Huang K,Zhan S

更新日期：2018-01-01 00:00:00

abstract：INTRODUCTION:Evidence suggests the current verbal risk descriptors used to communicate side effect risk in patient information leaflets (PILs) are overestimated. OBJECTIVES:The aim was to establish how people understand the verbal risk descriptors recommended for use in PILs by the European Commission (EC), and altern...

journal_title：Drug safety

authors： Webster RK,Weinman J,Rubin GJ

更新日期：2017-08-01 00:00:00

abstract：INTRODUCTION:New pharmacovigilance legislation was adopted in the EU in 2010 and became operational in July 2012. The legislation placed an obligation on all national competent authorities (NCAs) and marketing authorisation holders (MAHs) to record and report cases of suspected adverse drug reactions (ADRs) received fr...

journal_title：Drug safety

authors： Banovac M,Candore G,Slattery J,Houÿez F,Haerry D,Genov G,Arlett P

更新日期：2017-07-01 00:00:00

abstract：:Two Japanese regulatory agencies, the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency announced the implementation of a new review system called 'Conditional Approval,' specifically for the emerging field of regenerative medicine, in an amendment to the Pharmaceutical Affairs ...

journal_title：Drug safety

authors： Inokuma Y

更新日期：2017-06-01 00:00:00

abstract：INTRODUCTION:Pharmacovigilance, the monitoring of drug safety after marketing approval, highly depends on the adequate reporting of adverse drug reactions (ADRs). To improve pharmacovigilance awareness and future ADR reporting among medical students, we developed and evaluated a student-run pharmacovigilance programme....

journal_title：Drug safety

authors： Schutte T,Tichelaar J,Reumerman MO,van Eekeren R,Rolfes L,van Puijenbroek EP,Richir MC,van Agtmael MA

更新日期：2017-05-01 00:00:00

abstract：:Causality in pharmacovigilance is a difficult and time consuming exercise. This paper presents the challenges in determining causation by drug therapy. The first is that causation is complex and needs to be viewed from the context of the patient treated, rather than the drug product. Multiple causal vectors should be ...

journal_title：Drug safety

authors： Ralph Edwards I

更新日期：2017-05-01 00:00:00

abstract：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 medicatio...

journal_title：Drug safety

authors： Huijgen NA,Goijen HJ,Twigt JM,Mulders AG,Lindemans J,Dohle GR,Laven JS,Steegers-Theunissen RP

更新日期：2017-03-01 00:00:00

abstract：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 ...

journal_title：Drug safety

authors： Nardone B,Majewski S,Kim AS,Kiguradze T,Martinez-Escala EM,Friedland R,Amin A,Laumann AE,Edwards BJ,Rademaker AW,Martini MC,West DP

更新日期：2017-03-01 00:00:00

abstract：:Thrombocytopenia has been reported as an adverse reaction of numerous drugs. Vancomycin is often overlooked as a culprit but has been associated with several cases of thrombocytopenia that were not well described in the literature. A literature search was conducted to find reports of thrombocytopenia induced by vancom...

journal_title：Drug safety

authors： Mohammadi M,Jahangard-Rafsanjani Z,Sarayani A,Hadjibabaei M,Taghizadeh-Ghehi M

更新日期：2017-01-01 00:00:00

abstract：:Since 2008, the direct-acting oral anticoagulants (DOACs) have expanded the therapeutic options of cardiovascular diseases with recognized clinical and epidemiological impact, such as non-valvular atrial fibrillation (NVAF) and venous thromboembolism (VTE), and also in the preventive setting of orthopedic surgical pat...

journal_title：Drug safety

authors： Raschi E,Bianchin M,Ageno W,De Ponti R,De Ponti F

更新日期：2016-12-01 00:00:00

abstract：INTRODUCTION:The case-population approach compares exposure among cases to that of their source population. By using aggregated data to estimate the denominator, this approach can provide a real-time estimate of an association that could be particularly valuable to explore urgent vaccine safety concerns and to generate...

journal_title：Drug safety

authors： Théophile H,Moore N,Robinson P,Bégaud B,Pariente A

更新日期：2016-12-01 00:00:00

abstract：INTRODUCTION:The nature of medication errors (MEs) and the frequency of identified or intercepted MEs are not being scrutinized in daily practice in Japan. OBJECTIVES:The aim of this study was to clarify the epidemiology of MEs and the risk factors for non-intercepted and unidentified MEs. METHODS:The Japan Adverse D...

journal_title：Drug safety

authors： Noguchi C,Sakuma M,Ohta Y,Bates DW,Morimoto T

更新日期：2016-11-01 00:00:00

abstract：:It has been more than 25 years since an adverse drug reaction (ADR) monitoring agency was first established in China. In the past few years, the National ADR Monitoring System (NADRMS) has developed rapidly in the country. However, this system has not been reviewed in detail in the literature. Our aim was to demonstra...

journal_title：Drug safety

authors： Hou Y,Li X,Wu G,Ye X

更新日期：2016-11-01 00:00:00

abstract：:The development of antiretroviral therapy (ART) has dramatically increased the lifespan of HIV patients but treatment is complicated by numerous adverse effects and toxicities. ART complications include neuropsychiatric, metabolic, gastrointestinal, cardiac, and numerous other toxicities, and clinicians often have to ...

journal_title：Drug safety

authors： Treisman GJ,Soudry O

更新日期：2016-10-01 00:00:00

abstract：:The biologics have revolutionized the treatment of rheumatoid arthritis (RA). However, there are still patients that are difficult to control and a cure is still not achievable. Tofacitinib, a Janus kinase (JAK) inhibitor is an orally available, new-in-class, disease-modifying anti-rheumatic drug with similar efficacy...

journal_title：Drug safety

authors： Yamaoka K

更新日期：2016-09-01 00:00:00

abstract：INTRODUCTION:The epidemiology of naturally occurring intussusception is known to increase significantly between the ages of 3 and 8 months. Post-licensure studies have reported a fivefold and twofold increase in intussusception in the first week after the first dose and second dose, respectively, of current rotavirus v...

journal_title：Drug safety

authors： Yung CF,Chong CY,Thoon KC

更新日期：2016-08-01 00:00:00

abstract：:Boxed warnings-also known as "black box" warnings-can be a powerful tool in communicating drug risks to physicians and patients. The overall number of boxed warnings has grown in recent years as the US Food and Drug Administration (FDA) has approved more drugs on the basis of limited pre-marketing information and as n...

journal_title：Drug safety

authors： Yeh JS,Sarpatwari A,Kesselheim AS

更新日期：2016-08-01 00:00:00

abstract：:The mitochondrial respiratory chain (MRC) and ATP synthase (complex V) play an essential role in cellular energy production by the process of oxidative phosphorylation. In addition to inborn errors of metabolism, as well as secondary causes from disease pathophysiology, an impairment of oxidative phosphorylation can r...

journal_title：Drug safety

authors： Hargreaves IP,Al Shahrani M,Wainwright L,Heales SJ

更新日期：2016-07-01 00:00:00

abstract：INTRODUCTION:Pharmacovigilance includes analysis of large databases of information on drugs and events using algorithms that detect disproportional frequencies of associations. In order to test such algorithms, attempts have been made to provide canonical reference lists of so-called 'positive controls' and 'negative c...

journal_title：Drug safety

authors： Hauben M,Aronson JK,Ferner RE

更新日期：2016-05-01 00:00:00

abstract：:In August 2015, the US Food and Drug Administration (FDA) made the controversial decision to approve flibanserin (Addyi®) for women experiencing hypoactive sexual desire disorder. A number of factors contributed to disagreements regarding the FDA's decision, including the product's two prior failed FDA reviews, the un...

journal_title：Drug safety

authors： Baksh SN,Gellad WF,Alexander GC

更新日期：2016-05-01 00:00:00

abstract：:Probiotics have seen widespread use for a variety of gastrointestinal problems, especially in two common disorders: irritable bowel syndrome and inflammatory bowel disease. Since a wide variety of probiotic preparations has been used, and despite a large number of studies performed, a great deal of heterogeneity exist...

journal_title：Drug safety

authors： Bennett WE Jr

更新日期：2016-04-01 00:00:00

abstract：INTRODUCTION AND OBJECTIVE:Pharmacovigilance requirements for biologics mandate that EU Member States shall ensure that any biologic that is the subject of a suspected adverse drug reaction (ADR) is identifiable by brand name and batch number. Recent studies showed that brand name identification is well established, wh...

journal_title：Drug safety

authors： Klein K,Scholl JH,Vermeer NS,Broekmans AW,Van Puijenbroek EP,De Bruin ML,Stolk P

更新日期：2016-02-01 00:00:00

abstract：:The non-vitamin K antagonist oral anticoagulants (NOACs) are used for thromboembolic prophylaxis of patients with atrial fibrillation and in the treatment as well as secondary prophylaxis of patients with venous thromboembolism. Even though NOACs have a better safety profile than vitamin K antagonists (VKAs), there wi...

journal_title：Drug safety

authors： Husted S,Verheugt FW,Comuth WJ

更新日期：2016-01-01 00:00:00

abstract：:Randomized controlled trials always report the dose assessed and usually include a measure of adherence. By comparison, observational studies assessing medication safety often fail to report the dose used and rarely report any measure of adherence to therapy. This limits the ability to control for differences in doses...

journal_title：Drug safety

authors： Roughead EE,Pratt NL

更新日期：2015-12-01 00:00:00

abstract：INTRODUCTION:The prevalence of polymorphisms among the metabolising enzymes and pharmacodynamic receptors relevant for the thiazolidinediones differs by ethnic group, a factor that may modify risk of adverse drug events. OBJECTIVE:The aim of the study was to determine if the risk of oedema or heart failure associated ...

journal_title：Drug safety

authors： Roughead EE,Chan EW,Choi NK,Kimura M,Kimura T,Kubota K,Lai EC,Man KK,Nguyen TA,Ooba N,Park BJ,Sato T,Shin JY,Wang T,Griffiths J,Wong IC,Yang YH,Pratt NL

更新日期：2015-09-01 00:00:00

abstract：INTRODUCTION:An often key component to coordinating surveillance activities across distributed networks is the design and implementation of a common data model (CDM). The purpose of this study was to evaluate two drug safety surveillance CDMs from an ecosystem perspective to better understand how differences in CDMs an...

journal_title：Drug safety

authors： Xu Y,Zhou X,Suehs BT,Hartzema AG,Kahn MG,Moride Y,Sauer BC,Liu Q,Moll K,Pasquale MK,Nair VP,Bate A

更新日期：2015-08-01 00:00:00

abstract：:Adverse drug reactions (ADRs) cause considerable mortality and morbidity but no recent reviews are currently available for the European region. Therefore, we performed a review of all epidemiological studies quantifying ADRs in a European setting that were published between 1 January 2000 and 3 September 2014. Include...

journal_title：Drug safety

authors： Bouvy JC,De Bruin ML,Koopmanschap MA

更新日期：2015-05-01 00:00:00

abstract：:All national guidelines for the management of hypertension recommend angiotensin receptor blockers (ARBs) as an initial or add-on antihypertensive therapy. The eight available ARBs have variable clinical efficacy when used for control of hypertension. Additive blood pressure-lowering effects have been demonstrated whe...

journal_title：Drug safety

authors： Abraham HM,White CM,White WB

更新日期：2015-01-01 00:00:00

abstract：BACKGROUND:Problematic prescription drug use is reflected by or associated with drug-seeking aberrant behaviours. Research gaps include lack of post-marketing evidence and instruments. As part of the pharmacovigilance requirements, a risk management plan was developed for fentanyl buccal tablets (FEBT) by the manufactu...

journal_title：Drug safety

authors： Layton D,Osborne V,Al-Shukri M,Shakir SA

更新日期：2014-08-01 00:00:00

abstract：:The entire drug safety enterprise has a need to search, retrieve, evaluate, and synthesize scientific evidence more efficiently. This discovery and synthesis process would be greatly accelerated through access to a common framework that brings all relevant information sources together within a standardized structure. ...

journal_title：Drug safety

authors： Boyce RD,Ryan PB,Norén GN,Schuemie MJ,Reich C,Duke J,Tatonetti NP,Trifirò G,Harpaz R,Overhage JM,Hartzema AG,Khayter M,Voss EA,Lambert CG,Huser V,Dumontier M

更新日期：2014-08-01 00:00:00

abstract：:Gastroesophageal reflux is one of the most common reasons for referrals to paediatricians or paediatric gastroenterologists. Gastric acid-buffering agents, mucosal surface barriers and gastric anti-secretory agents are the main groups of medications currently used for treating gastroesophageal reflux disease (GERD) in...

journal_title：Drug safety

authors： Kierkus J,Oracz G,Korczowski B,Szymanska E,Wiernicka A,Woynarowski M

更新日期：2014-05-01 00:00:00

abstract：BACKGROUND:Individual case reports of suspected harm from medicines are fundamental for signal detection in postmarketing surveillance. Their effective analysis requires reliable data and one challenge is report duplication. These are multiple unlinked records describing the same suspected adverse drug reaction (ADR) i...

journal_title：Drug safety

authors： Tregunno PM,Fink DB,Fernandez-Fernandez C,Lázaro-Bengoa E,Norén GN

更新日期：2014-04-01 00:00:00

abstract：BACKGROUND:Thorough QT studies are typically conducted for drugs with systemic bioavailability and include a positive control, typically moxifloxacin, with a well-described QTc effect. OBJECTIVE:This study tested two hypotheses: that (i) re-measuring the QT intervals based on electrocardiogram (ECG) pattern similarity...

journal_title：Drug safety

authors： Johannesen L,Garnett C,Malik M

更新日期：2014-03-01 00:00:00

abstract：BACKGROUND:At time of approval, knowledge of the full benefit risk of any drug is limited, in particular with regards to safety. Post-approval surveillance of potential drug safety concerns is recognized as an important task of regulatory agencies. For innovative, often first-in-class drugs, safety knowledge at time of...

journal_title：Drug safety

authors： Mol PG,Arnardottir AH,Motola D,Vrijlandt PJ,Duijnhoven RG,Haaijer-Ruskamp FM,de Graeff PA,Denig P,Straus SM

更新日期：2013-11-01 00:00:00

abstract：BACKGROUND:Researchers using observational data to understand drug effects must make a number of analytic design choices that suit the characteristics of the data and the subject of the study. Review of the published literature suggests that there is a lack of consistency even when addressing the same research question...

journal_title：Drug safety

authors： Stang PE,Ryan PB,Overhage JM,Schuemie MJ,Hartzema AG,Welebob E

更新日期：2013-10-01 00:00:00

abstract：BACKGROUND:The availability of large-scale observational healthcare data allows for the active monitoring of safety of drugs, but research is needed to determine which statistical methods are best suited for this task. Recently, the Longitudinal Gamma Poisson Shrinker (LGPS) and Longitudinal Evaluation of Observational...

journal_title：Drug safety

authors： Schuemie MJ,Madigan D,Ryan PB

更新日期：2013-10-01 00:00:00

abstract：BACKGROUND:Acute liver failure is idiopathic and drug-related in, respectively, around 50 and 15 % of children. Population-based, epidemiologic data about the pattern of disease manifestation and incidence of less severe acute liver injury, either idiopathic or potentially drug-attributed are limited in children and ad...

journal_title：Drug safety

authors： Ferrajolo C,Verhamme KM,Trifirò G,'t Jong GW,Giaquinto C,Picelli G,Oteri A,de Bie S,Valkhoff VE,Schuemie MJ,Mazzaglia G,Cricelli C,Rossi F,Capuano A,Sturkenboom MC

更新日期：2013-10-01 00:00:00

abstract：BACKGROUND:Depressive disorders and use of antidepressants are associated with adverse effects on sexual function. In pharmacoepidemiological studies, sexual disorders are reported by more than 50 % of patients taking serotonin reuptake inhibitors (SRIs). OBJECTIVE:The aim of this study was to determine the reporting ...

journal_title：Drug safety

authors： Trenque T,Maura G,Herlem E,Vallet C,Sole E,Auriche P,Drame M

更新日期：2013-07-01 00:00:00

abstract：:Tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of certain forms of cancers, raising hopes for many patients with otherwise unresponsive tumours. While these agents are generally well tolerated, clinical experience with them has highlighted their unexpected association with serious toxic effects on...

journal_title：Drug safety

authors： Shah DR,Shah RR,Morganroth J

更新日期：2013-06-01 00:00:00

abstract：:Rechallenge is defined as the readministration of a medication suspected of being a possible cause of an adverse reaction and which has been discontinued as result. It may be unintentional when the appearance of a reaction was initially not attributed to the medication. A rechallenge may be intentional when a prescrib...

journal_title：Drug safety

authors： Stanulović V,Venegoni M,Edwards B

更新日期：2013-03-01 00:00:00