Database size and power to detect safety signals in pharmacovigilance.

abstract：INTRODUCTION:ACE inhibitors are first-line therapy in patients with chronic kidney disease (CKD). The main adverse effects of ACE inhibitors are hypotension, renal function impairment and hyperkalemia. AREAS COVERED:This paper reviews evidence from clinical studies regarding adverse effects of ACE inhibitors in patien...

journal_title：Expert opinion on drug safety

authors： Sidorenkov G,Navis G

更新日期：2014-10-01 00:00:00

abstract：INTRODUCTION:The polycystic ovary syndrome (PCOS) is a very prevalent disorder in premenopausal women. Cardiovascular risk factors cluster in these patients, raising concern about the safety of the drugs commonly used to ameliorate symptoms of androgen excess in in this population at risk of cardiovascular morbidity. ...

journal_title：Expert opinion on drug safety

authors： Luque-Ramírez M,Ortiz-Flores AE,Nattero-Chávez L,Escobar-Morreale HF

更新日期：2020-12-01 00:00:00

abstract：:Osteonecrosis of the jaw is a new disease, partly caused by bisphosphonates. It is commonly assumed that the bisphosphonates somehow cause cell death (osteocyte necrosis) within the jawbone, which makes it prone to chronic infection. In this article, an alternative pathogenetic theory is suggested, based on the normal...

journal_title：Expert opinion on drug safety

authors： Aspenberg P

更新日期：2006-11-01 00:00:00

abstract：INTRODUCTION:Hyperphosphatemia is common in the late stages of chronic kidney disease (CKD) and is associated with elevated parathormone levels, abnormal bone mineralization, extraosseous calcification and increased risk of cardiovascular events and death. Several classes of oral phosphate binders are available to help...

journal_title：Expert opinion on drug safety

authors： Locatelli F,Del Vecchio L,Violo L,Pontoriero G

更新日期：2014-05-01 00:00:00

abstract：INTRODUCTION:Although anaphylaxis is a relatively common disorder, clinicians and scientists have debated on how to best define and manage this condition. The current recommendations are focused on the central role of adrenaline, but evidence in support of this therapeutic approach is modest, mainly for the lack of wel...

journal_title：Expert opinion on drug safety

authors： Cervellin G,Sanchis-Gomar F,Lippi G

更新日期：2016-06-01 00:00:00

abstract：IMPORTANCE OF THE FIELD:HIV-infection has become a chronic disease in paediatric patients with the potential for long-term survival and exposure to antiretroviral (ARV) therapies for 2 decades longer than HIV-infected adults. On the other hand, the administration of ARV to HIV-infected pregnant women has greatly increa...

journal_title：Expert opinion on drug safety

authors： Viganò A,Cerini C,Pattarino G,Fasan S,Zuccotti GV

更新日期：2010-05-01 00:00:00

abstract：INTRODUCTION:The Annual Meeting of the Safety Pharmacology (SP) Society is a yearly event designed to keep attendees abreast of how to best identify and mitigate organ function liabilities of candidate drugs selected for clinical assessment. AREAS COVERED:Heart rate (HR) and blood pressure (BP) effects of candidate dr...

journal_title：Expert opinion on drug safety

authors： Cavero I

更新日期：2015-06-01 00:00:00

abstract：BACKGROUND:Ximelagatran, the first oral agent in the new class of direct thrombin inhibitors, was withdrawn from the market due to increased rates of liver enzyme elevations in long-term treatments. Despite intensive pre clinical investigations the cellular mechanisms behind the observed hepatic effects remain unknown....

journal_title：Expert opinion on drug safety

authors： Ainscow EK,Pilling JE,Brown NM,Orme AT,Sullivan M,Hargreaves AC,Cooke EL,Sullivan E,Carlsson S,Andersson TB

更新日期：2008-07-01 00:00:00

abstract：:Unlicensed and off-label prescribing is common in children. This is likely to be due to a combination of the difficulty in carrying out reliable clinical trials in children and the lack of financial reward for the industry. The term 'paediatric' encompasses preterm babies to near adult-sized adolescents, and all aspec...

journal_title：Expert opinion on drug safety

authors： Bush A

更新日期：2003-03-01 00:00:00

abstract：INTRODUCTION:Unfractionated heparin is an anticoagulant used in the treatment of myocardial infarction, pulmonary embolism and other thrombotic disorders. However, with anticoagulation comes the risk of bleeding and adverse events. These risks increase with supratherapeutic dosing. AREAS COVERED:In this review, we dis...

journal_title：Expert opinion on drug safety

authors： Krishnaswamy A,Lincoff AM,Cannon CP

更新日期：2011-01-01 00:00:00

abstract：IMPORTANCE OF THE FIELD:Clopidogrel is an antiplatelet prodrug widely used in acute coronary syndromes and after intravascular stent placement. Acute or chronic use can cause bleeding, a major adverse effect, which can lead to drug discontinuation or noncompliance with therapy. AREAS COVERED IN THIS REVIEW:The mechani...

journal_title：Expert opinion on drug safety

authors： Mangalpally KK,Kleiman NS

更新日期：2011-01-01 00:00:00

abstract：:Introduction: Rucaparib is increasingly being utilized for women with recurrent ovarian cancer both as treatment and maintenance therapy. Poly-ADP ribose polymerase (PARP) inhibitors like rucaparib are daily oral medication that exploit the DNA repair pathway. The most significant clinical benefit is in those tumors e...

journal_title：Expert opinion on drug safety

authors： Cosgrove CM,O'Malley DM

更新日期：2018-12-01 00:00:00

abstract：:The objective of this review is to describe psychiatric adverse events occurring after ingestion of dietary supplements containing herbal ephedra and to assess the possible relationship between supplement use and the events. The authors reviewed all adverse event reports related to dietary supplements containing herba...

journal_title：Expert opinion on drug safety

authors： Maglione M,Miotto K,Iguchi M,Hilton L,Shekelle P

更新日期：2005-09-01 00:00:00

abstract：:Objectives: This study aimed to develop a procedure to explore the adverse drug reaction signals of drug-induced neutropenia (DIN) or drug-induced agranulocytosis (DIA) in children using an electronic health records (EHRs) database. Methods: A two-stage design was presented. First, the suspected drugs to induce DIN or...

journal_title：Expert opinion on drug safety

authors： Wei R,Jia LL,Yu YC,Nie XL,Song ZY,Fan DF,Xie YF,Peng XX,Zhao ZG,Wang XL

更新日期：2019-05-01 00:00:00

abstract：OBJECTIVE:To analyze the extent to which Spanish leaflets and drug information on the Net met quality criteria. RESEARCH DESIGN AND METHODS:A descriptive study was conducted comparing readability (REA) and comprehensibility (COM) criteria of a random sample of 77 marketed products of the 12 active ingredients most fre...

journal_title：Expert opinion on drug safety

authors： Mira JJ,Lorenzo S,Pérez-Jover V,Navarro I,Martín de Rosales AM,Lara C

更新日期：2013-01-01 00:00:00

abstract：INTRODUCTION:Development of new drugs in oncology may have implications for cardiovascular risk. This report describes some aspects of our growing knowledge in the area of evaluating benefit-risk and may be of direct importance to scientists working in drug discovery and development. AREAS COVERED:This report of webin...

journal_title：Expert opinion on drug safety

authors： Braddock M,Heilbraun J,Mendzelevski B

更新日期：2013-09-01 00:00:00

abstract：IMPORTANCE OF THE FIELD:Bisphosphonates are the most widely used antiresorptive agents for the treatment of osteoporosis. However, the cumulative bisphoshonate exposure and its association with atypical fragility fractures, and the optimum duration of treatment remain obscure. AREAS COVERED IN THIS REVIEW:This review ...

journal_title：Expert opinion on drug safety

authors： Charopoulos I,Orme S,Giannoudis PV

更新日期：2011-01-01 00:00:00

abstract：OBJECTIVE:To review long-term safety data from the rollover study ETV-901, focusing on adverse events (AEs) with a potential nucleos(t)ide association. METHODS:The open-label study ETV-901 (AI463901) assessed the safety of entecavir in chronic hepatitis B patients who received entecavir, lamivudine or adefovir monothe...

journal_title：Expert opinion on drug safety

authors： Manns MP,Akarca US,Chang TT,Sievert W,Yoon SK,Tsai N,Min A,Pangerl A,Beebe S,Yu M,Wongcharatrawee S

更新日期：2012-05-01 00:00:00

abstract：:The optimum anti-HIV drug has yet to be found. This paper will summarise some of the oral adverse effects associated with antiretroviral agents against HIV. The development of antiretroviral drugs for the treatment of HIV infection has been aimed at the inactivation of two HIV enzymes: reverse transcriptase and protea...

journal_title：Expert opinion on drug safety

authors： Diz Dios P,Scully C

更新日期：2002-11-01 00:00:00

abstract：INTRODUCTION:Hepatitis C virus is a hepatotropic virus that generally leads to chronic hepatitis and various harmful sequelae. The lone standard of treatment has been pegylated interferon and ribavirin, which produces a modest response and many side effects. However, a new era of management was declared with the introd...

journal_title：Expert opinion on drug safety

authors： El Kassas M,Elbaz T,Hafez E,Esmat G

更新日期：2016-12-01 00:00:00

abstract：INTRODUCTION:The introduction of pneumococcal conjugate vaccines (PCVs) in the routine immunization program has resulted in a significant decline in invasive pneumococcal diseases (IPD) around the world. Preterm infants are a special group at a high risk of invasive infection by encapsulated bacteria. However, their sl...

journal_title：Expert opinion on drug safety

authors： López-Sanguos C,Rivero Calle I,Rodriguez Tenreiro C,Raguindin PF,Martinón-Torres F

更新日期：2019-04-01 00:00:00

abstract：BACKGROUND:This meta-analysis has been conducted to determine the risk of elevated transaminases associated with immune checkpoint inhibitors use in patients with cancer. METHODS:Studies eligible for our analysis included randomized Phase II and III trials of patients with cancer on ipilimumab, nivolumab, pembrolizuma...

journal_title：Expert opinion on drug safety

authors： Abdel-Rahman O,ElHalawani H,Fouad M

更新日期：2015-10-01 00:00:00

abstract：:NSAIDs are used extensively worldwide at a cost of billions of dollars annu-ally. Adverse side effects, especially in the gastrointestinal (GI) tract, are uncommon but cause a substantial burden of illness because of the volume of use. Important upper GI complications include dyspepsia, gastric erosions and peptic ulc...

journal_title：Expert opinion on drug safety

authors： Peng S,Duggan A

更新日期：2005-03-01 00:00:00

abstract：INTRODUCTION:Cardiovascular (CV) diseases are the leading cause of death and disability in the developed countries. Lipid-lowering therapy is a cornerstone of the CV risk modification strategy. The first line treatment for hyperlipidemia is statins, which decrease low-density lipoprotein cholesterol (LDL-C) by 30-50% a...

journal_title：Expert opinion on drug safety

authors： Strilchuk L,Fogacci F,Cicero AF

更新日期：2019-07-01 00:00:00

abstract：INTRODUCTION:The prevalence of depression in pregnancy is over 10% and a significant proportion of pregnant women use antidepressant medication. The safety of antidepressants in pregnancy is controversial, partly due to methodological challenges. The conflicting results in the literature may, however, also be due to di...

journal_title：Expert opinion on drug safety

authors： Pedersen LH

更新日期：2017-08-01 00:00:00

abstract：:Psychosis in Alzheimer's disease is common and troublesome. The impact on the quality of life of both patients and caregivers is high and drug treatments raise concern in terms of both efficacy and safety. Therefore, identifying the risk factors that play an important role in the onset of psychosis is mandatory for th...

journal_title：Expert opinion on drug safety

authors： Cancelli I,Beltrame M,D'Anna L,Gigli GL,Valente M

更新日期：2009-09-01 00:00:00

abstract：:In October of 2003, the FDA issued a public health warning stating that preliminary evidence showed selective serotonin re-uptake inhibitors (SSRIs) and related antidepressants might be associated with excess reports of suicidality. In 2004, the FDA convened a committee of neuropsychiatric and pediatric subcommittee m...

journal_title：Expert opinion on drug safety

authors： Gören JL

更新日期：2008-05-01 00:00:00

abstract：INTRODUCTION:Many commonly used drugs have primary or secondary anticholinergic effects contributing to adverse outcomes ranging from mild-to-severe to potentially lethal. Anticholinergic adverse effects frequently occur with medications prescribed with other intended mechanisms of action, including antihistamines, ant...

journal_title：Expert opinion on drug safety

authors： Gerretsen P,Pollock BG

更新日期：2011-09-01 00:00:00

abstract：:Introduction: Psoriasis is a chronic inflammatory systemic disease that affects 2% of the population and is associated with an important physical and physiological burden. About 0.5-2% of psoriatic cases onset during the pediatric age range, and often it's not diagnosed until adulthood. Adalimumab is an antitumor necr...

journal_title：Expert opinion on drug safety

authors： Zangrilli A,Bavetta M,Bianchi L

更新日期：2020-04-01 00:00:00

abstract：INTRODUCTION:Albiglutide is a marketed long acting GLP-1 receptor agonist (GLP-1 RA) administered by weekly injection. It has significantly less gastrointestinal side effects than other GLP-1 RAs in current use but does not improve HbA1c or promote weight loss to the same extent as competitor agents such as liraglutide...

journal_title：Expert opinion on drug safety

authors： Rendell MS

更新日期：2017-09-01 00:00:00