abstract：:Pharmacovigilance is the science of monitoring the effects of medicinal products to identify and evaluate potential adverse reactions and provide necessary and timely risk mitigation measures. Intelligent automation technologies have a strong potential to automate routine work and to balance resource use across safety...

journal_title：Drug safety

authors： Huysentruyt K,Kjoersvik O,Dobracki P,Savage E,Mishalov E,Cherry M,Leonard E,Taylor R,Patel B,Abatemarco D

更新日期：2021-02-01 00:00:00

abstract：INTRODUCTION:There are few studies assessing how data on adverse drug events from consumers on social media compare with other sources. AIM:The aim of this study was to assess the consistency of adverse event data of statin medications from social media as compared with other sources. METHODS:We collected data on the...

journal_title：Drug safety

authors： Golder S,Smith K,O'Connor K,Gross R,Hennessy S,Gonzalez-Hernandez G

更新日期：2021-02-01 00:00:00

abstract：INTRODUCTION:Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9Is) were associated with a risk of neurocognitive adverse drug reactions (ADRs). OBJECTIVE:We aimed to investigate the occurrence of neuropsychiatric ADRs related to PCSK9Is. METHODS:We analyzed Individual Case Safety Reports (ICSRs) sent thr...

journal_title：Drug safety

authors： di Mauro G,Zinzi A,Scavone C,Mascolo A,Gaio M,Sportiello L,Ferrajolo C,Rafaniello C,Rossi F,Capuano A

更新日期：2020-12-22 00:00:00

abstract：INTRODUCTION:Checkpoint inhibitor drugs including ipilimumab have been reported to induce intestinal injury. OBJECTIVE:We aimed to evaluate the risk of chronic (> 6 weeks) enterocolitis following ipilimumab administration, and the likelihood that an enteritis vs colitis or enterocolitis is seen. PATIENTS AND METHODS:...

journal_title：Drug safety

authors： Witges K,Shafer LA,Zarychanski R,Abou-Setta AM,Rabbani R,Dingwall O,Bernstein CN

更新日期：2020-12-01 00:00:00

abstract：INTRODUCTION:Detecting signals of safety concerns associated with complementary medicines (CMs) relies on spontaneous reports submitted by health professionals and patients/consumers. Community pharmacists are well placed to identify and report suspected adverse drug reactions (ADRs) associated with CMs, but pharmacist...

journal_title：Drug safety

authors： Barnes J,Butler R

更新日期：2020-11-01 00:00:00

abstract：INTRODUCTION:Reframing side-effect information in patient information leaflets (PILs) in terms of those who remain side-effect-free may reduce negative expectations and side-effects, although there are concerns this may impact informed consent. This study compared two versions of positively framed PILs with current pra...

journal_title：Drug safety

authors： Webster RK,Rubin GJ

更新日期：2020-10-01 00:00:00

abstract：INTRODUCTION:Adverse drug reactions (ADRs) are unintended reactions caused by a drug or combination of drugs taken by a patient. The current safety surveillance system relies on spontaneous reporting systems (SRSs) and more recently on observational health data; however, ADR detection may be delayed and lack geographic...

journal_title：Drug safety

authors： Li Y,Jimeno Yepes A,Xiao C

更新日期：2020-09-01 00:00:00

abstract：:This 'Erice Call for Change' is a report from a group of experts, patients and patient representatives who met in Erice in September 2019 following previous similar meetings after the original Erice Declaration (1996). The aim of the meeting was to discuss the challenge of causal complexity and individual variation in...

journal_title：Drug safety

authors： Rocca E,Anjum RL

更新日期：2020-06-01 00:00:00

abstract：INTRODUCTION:Theoretically, benzodiazepines (BZDs) can narrow the iridocorneal angle and induce acute angle-closure glaucoma (AACG). However, little evidence exists regarding this association. OBJECTIVE:The objective of this study was to assess whether the use of BZDs is associated with the risk of AACG. METHODS:We c...

journal_title：Drug safety

authors： Kim WJ,Li J,Oh IS,Song I,Lee E,Namkoong K,Shin JY

更新日期：2020-06-01 00:00:00

abstract：:Eosinophils play a pivotal role in the inflammatory pathology of asthma and have been the target of new biologic treatments for patients with eosinophilic asthma. Given the central role of interleukin (IL)-5 in the eosinophil lifecycle, several therapies directed against the IL-5 pathway have been developed, including...

journal_title：Drug safety

authors： Jackson DJ,Korn S,Mathur SK,Barker P,Meka VG,Martin UJ,Zangrilli JG

更新日期：2020-05-01 00:00:00

abstract：:The risk of coronary events with non-steroidal anti-inflammatory drugs has been the subject of much debate since the original trial of rofecoxib raised the issue. Since then, over almost 20 years, such risks have been shown in clinical trials of long-term high-dose users, and in observational studies comparing users w...

journal_title：Drug safety

authors： Moore N

更新日期：2020-04-01 00:00:00

abstract：INTRODUCTION:As asthma medications are frequently prescribed for children, knowledge of the safety of these drugs in the paediatric population is important. Although spontaneous reports cannot be used to prove causality of adverse events, they are important in the detection of safety signals. OBJECTIVE:Our objective w...

journal_title：Drug safety

authors： Baan EJ,de Smet VA,Hoeve CE,Pacurariu AC,Sturkenboom MCJM,de Jongste JC,Janssens HM,Verhamme KMC

更新日期：2020-01-01 00:00:00

abstract：INTRODUCTION:Real-world data on the comparative effectiveness and safety of switching among different epoetins (including originators and biosimilars) are limited. In light of current debate about interchangeability, prescribers, some patient groups and decision makers are calling for additional post-marketing evidence...

journal_title：Drug safety

authors： Belleudi V,Trotta F,Addis A,Ingrasciotta Y,Ientile V,Tari M,Gini R,Pastorello M,Scondotto S,Cananzi P,Traversa G,Davoli M,Trifirò G,Italian Biosimilar Network (ItaBioNet).

更新日期：2019-12-01 00:00:00

abstract：INTRODUCTION:Evaluation of risk minimization (RM) actions is an emerging area of regulatory science, often without tools to rapidly and systematically assess their effectiveness. PURPOSE:The aim of this study was to evaluate whether chronographs, typically used for rapid signal detection in observational longitudinal ...

journal_title：Drug safety

authors： Sobel RE,Blackwell W,Fram DM,Bate A

更新日期：2019-11-01 00:00:00

abstract：BACKGROUND:There are no head-to-head randomized controlled trials comparing different direct oral anticoagulants (DOACs). Thus, we systematically reviewed and meta-analyzed observational studies assessing the comparative effectiveness and safety of DOACs for stroke prevention in patients with atrial fibrillation (AF). ...

journal_title：Drug safety

authors： Douros A,Durand M,Doyle CM,Yoon S,Reynier P,Filion KB

更新日期：2019-10-01 00:00:00

abstract：:Communications about the safety and effectiveness of human drugs can influence patients' and prescribers' perceptions and behaviors, which in turn can affect the public's health more broadly. We conducted a critical review of the literature on the unintended effects from communicating information to the public about s...

journal_title：Drug safety

authors： DeFrank JT,McCormack L,West SL,Lefebvre C,Burrus O

更新日期：2019-10-01 00:00:00

abstract：BACKGROUND AND PURPOSE:Selective serotonin reuptake inhibitors (SSRIs) are frequently prescribed in the elderly due to a more favorable risk profile than other antidepressants (ADs). However, SSRIs are associated with an increased risk of gastrointestinal bleeding, while evidence on the risk of hemorrhagic stroke (HS) ...

journal_title：Drug safety

authors： Schäfer W,Princk C,Kollhorst B,Schink T

更新日期：2019-09-01 00:00:00

abstract：INTRODUCTION:Adverse event (AE) under-reporting has been a recurrent issue raised during health authorities Good Clinical Practices (GCP) inspections and audits. Moreover, safety under-reporting poses a risk to patient safety and data integrity. The current clinical Quality Assurance (QA) practices used to detect AE un...

journal_title：Drug safety

authors： Ménard T,Barmaz Y,Koneswarakantha B,Bowling R,Popko L

更新日期：2019-09-01 00:00:00

abstract：INTRODUCTION:While medical chart review remains the gold standard to validate health conditions or events identified in administrative claims and electronic health record databases, it is time consuming, expensive and can involve subjective decisions. AIM:The aim of this study was to describe the landscape of technolo...

journal_title：Drug safety

authors： Straub L,Gagne JJ,Maro JC,Nguyen MD,Beaulieu N,Brown JS,Kennedy A,Johnson M,Wright A,Zhou L,Wang SV

更新日期：2019-09-01 00:00:00

abstract：INTRODUCTION AND OBJECTIVE:The therapeutic role of fecal microbiota transplantation in ulcerative colitis varies across different reports. This study aims to evaluate the long-term safety and efficacy of a strategy called step-up fecal microbiota transplantation for ulcerative colitis. METHODS:Two clinical trials (NCT...

journal_title：Drug safety

authors： Ding X,Li Q,Li P,Zhang T,Cui B,Ji G,Lu X,Zhang F

更新日期：2019-07-01 00:00:00

abstract：INTRODUCTION:Although the mortality risk associated with tramadol use in children has triggered the revision of tramadol drug labeling, the mortality risk in adults has not been thoroughly explored. OBJECTIVE:The objective of this study was to evaluate whether tramadol use is associated with mortality in various risk ...

journal_title：Drug safety

authors： Jeong S,Tchoe HJ,Li J,Shin JY

更新日期：2019-06-01 00:00:00

abstract：:The article vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues, written by Tomas Bergvall. G. Niklas Norén. Marie Lindquist, was originally published Online First without open access. ...

journal_title：Drug safety

authors： Bergvall T,Norén GN,Lindquist M

更新日期：2019-06-01 00:00:00

abstract：:Blinatumomab is the first-and-only Food and Drug Administration (FDA)-approved cluster of differentiation (CD) 19-directed CD3 bispecific T-cell engager (BiTE®) immunotherapy. It is currently FDA approved for the treatment of adults and children with Philadelphia chromosome-positive (Ph+) and Philadelphia chromosome-n...

journal_title：Drug safety

authors： Stein A,Franklin JL,Chia VM,Arrindell D,Kormany W,Wright J,Parson M,Amouzadeh HR,Choudhry J,Joseph G

更新日期：2019-05-01 00:00:00

abstract：:Since the introduction of the interferons in the 1990s, a multitude of different immunomodulatory and immunosuppressant disease-modifying therapies for multiple sclerosis (MS) have been developed. They have all shown positive effects on clinical endpoints such as relapse rate and disease progression and are a heteroge...

journal_title：Drug safety

authors： Förster M,Küry P,Aktas O,Warnke C,Havla J,Hohlfeld R,Mares J,Hartung HP,Kremer D

更新日期：2019-05-01 00:00:00

abstract：INTRODUCTION:Adverse drug events (ADEs) may represent an important item of expenditure for healthcare systems and their prevention could be associated with a relevant cost saving. OBJECTIVE:The objective of this study was to simulate the annual economic burden for ADEs in Tuscany (Italy) and the potential cost savings...

journal_title：Drug safety

authors： Convertino I,Salvadori S,Pecori A,Galiulo MT,Ferraro S,Parrilli M,Corona T,Turchetti G,Blandizzi C,Tuccori M

更新日期：2019-03-01 00:00:00

abstract：:Histone deacetylases (HDACs) are expressed at increased levels in cells of various malignancies, and the use of HDAC inhibitors has improved outcomes in patients with haematological malignancies (T-cell lymphomas and multiple myeloma). However, they are not as effective in solid tumours. Five agents are currently appr...

journal_title：Drug safety

authors： Shah RR

更新日期：2019-02-01 00:00:00

abstract：:Adoptive T cell therapy (ACT) is a safe and effective personalized cancer immunotherapy that can comprise naturally occurring ex vivo expanded cells (e.g., tumor-infiltrating lymphocytes [TIL]) or T cells genetically engineered to confer antigen specificity (T-cell receptor [TCR] or chimeric antigen receptor [CAR] eng...

journal_title：Drug safety

authors： Wolf B,Zimmermann S,Arber C,Irving M,Trueb L,Coukos G

更新日期：2019-02-01 00:00:00

abstract：INTRODUCTION:Romiplostim is a subcutaneously administered thrombopoietin-receptor agonist approved in the European Union for self-administration (or administration by a caregiver) in selected adult patients with chronic primary immune thrombocytopenia refractory to other treatments. To mitigate the risk of medication e...

journal_title：Drug safety

authors： Schipperus M,Kaiafa G,Taylor L,Wetten S,Kreuzbauer G,Boshier A,Seesaghur A

更新日期：2019-01-01 00:00:00

abstract：: ...

journal_title：Drug safety

authors： Simoons M,Seldenrijk A,Mulder H,van Roon E,Bakker R,Ruhé H

更新日期：2018-12-01 00:00:00

abstract：:In the original publication of the article, the trend line for non-EEA cases in figure 4 is incorrect. In this correction, the original Fig. 4 (Fig. 1) and the correct Fig. 4 (Fig. 2) are published. ...

journal_title：Drug safety

authors： Newbould V,Le Meur S,Goedecke T,Kurz X

更新日期：2018-12-01 00:00:00

abstract：:Adverse drug reactions (ADRs) can cause serious health problems, as shown in studies about drug-related hospitalizations. To build knowledge of and raise awareness about ADRs among healthcare professionals, more education in the field of ADRs and pharmacovigilance (PV) is needed. No standard exists for teaching PV at ...

journal_title：Drug safety

authors： van Eekeren R,Rolfes L,Koster AS,Magro L,Parthasarathi G,Al Ramimmy H,Schutte T,Tanaka D,van Puijenbroek E,Härmark L

更新日期：2018-11-01 00:00:00

abstract：INTRODUCTION:Non-steroidal anti-inflammatory drugs are associated with a dose and duration-dependent coronary risk. There is little information concerning analgesic-dose ibuprofen, among the most widely used drugs worldwide. OBJECTIVE:Our objective was to measure the risks of acute coronary syndrome (ACS) after dispen...

journal_title：Drug safety

authors： Duong M,Abouelfath A,Lassalle R,Droz C,Blin P,Moore N

更新日期：2018-11-01 00:00:00

abstract：:Dental caries is defined as a pathological breakdown of the tooth. It is an infectious phenomenon involving a multifactorial aetiology. The impact of drugs on cariogenic risk has been poorly investigated. ...

journal_title：Drug safety

authors： Patras de Campaigno E,Kebir I,Montastruc JL,Rueter M,Maret D,Lapeyre-Mestre M,Sallerin B,Despas F

更新日期：2018-08-01 00:00:00

abstract：INTRODUCTION:Previously, an app has been developed for healthcare professionals (HCPs) and patients to report adverse drug reactions (ADRs) to national medicines agencies and to receive drug safety information. OBJECTIVE:This study aimed to assess (1) European HCPs' and patients' interest in an app for this two-way ri...

journal_title：Drug safety

authors： de Vries ST,Denig P,Lasheras Ruiz C,Houÿez F,Wong L,Sutcliffe A,Mol PGM,IMI Web-RADR Work Package 3b Consortium.

更新日期：2018-07-01 00:00:00

abstract：: ...

journal_title：Drug safety

authors： Kawada T

更新日期：2018-06-01 00:00:00

abstract：INTRODUCTION:The use of mobile apps is increasing in medicine. In pharmacovigilance, mobile apps may help to increase adverse drug reaction reporting and improve the communication of safety issues. The Toulouse University Pharmacovigilance Center has developed VigiBIP®, a free smartphone app available on Android and Ap...

journal_title：Drug safety

authors： Montastruc F,Bagheri H,Lacroix I,Damase-Michel C,Chebane L,Rousseau V,Jouanjus E,Lapeyre-Mestre M,Durrieu G,Montastruc JL

更新日期：2018-05-01 00:00:00

abstract：:Human papillomavirus (HPV) vaccines are now included in immunisation programmes in 71 countries. Unfortunately, uptake has been impacted in some countries by reduced confidence in the safety of the HPV vaccine. In 2013, we published an extensive review demonstrating a reassuring safety profile for bivalent (2vHPV) and...

journal_title：Drug safety

authors： Phillips A,Patel C,Pillsbury A,Brotherton J,Macartney K

更新日期：2018-04-01 00:00:00

abstract：INTRODUCTION:Valbenazine is a novel vesicular monoamine transporter 2 inhibitor approved for the treatment of tardive dyskinesia in adults. OBJECTIVE:Using data from double-blind, placebo-controlled trials, analyses were conducted to evaluate the cardiovascular effects of once-daily valbenazine in patients with a psyc...

journal_title：Drug safety

authors： Thai-Cuarto D,O'Brien CF,Jimenez R,Liang GS,Burke J

更新日期：2018-04-01 00:00:00

abstract：INTRODUCTION:One-third of adults in the USA experience chronic pain and use a variety of painkillers, such as nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and opioids. However, some serious adverse events (AEs), such as cardiovascular incidents, overdose, and death, have been found to be related to pai...

journal_title：Drug safety

authors： Min J,Osborne V,Kowalski A,Prosperi M

更新日期：2018-03-01 00:00:00

abstract：:Impulse control disorders (ICDs) are a well-known adverse effect of dopamine agonists (DAAs). This critical review aims to summarize data on the prevalence and factors associated with the development of an ICD simultaneous to DAA use. A search of two electronic databases was completed from inception to July 2017. The ...

journal_title：Drug safety

authors： Grall-Bronnec M,Victorri-Vigneau C,Donnio Y,Leboucher J,Rousselet M,Thiabaud E,Zreika N,Derkinderen P,Challet-Bouju G

更新日期：2018-01-01 00:00:00