A review of the National pharmacovigilance system in Malta - implementing and operating a pharmacovigilance management system.

abstract：:Introduction: Botulinum toxin (BoNT) is a protein secreted by the anaerobic Gram-negative bacterium Clostridium botulinum. Among the seven known subtypes, type A is the most commonly used in women to treat diseases. It primarily blocks presynaptic release of acetylcholine at the neuromuscular junction, resulting in te...

journal_title：Expert opinion on drug safety

authors： Li W,Tang M

更新日期：2020-01-01 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 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：INTRODUCTION:Unintended harm from prescribing errors remains a prevalent concern in healthcare leading to significant morbidity and mortality around the world. Prescribers face new challenges to their practice in modern times such as increasingly complex health-care systems, an aging population with increasing multimor...

journal_title：Expert opinion on drug safety

authors： Coleman JJ

更新日期：2019-02-01 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：INTRODUCTION:ACE-inhibitors (ACEI) and diuretics are the typical first-line antihypertensive drugs with complementary mechanisms of action. The present paper is summarizing the evidence supporting the efficacy of their combination in a broad range of hypertensive patients. AREAS COVERED:This source of data is differen...

journal_title：Expert opinion on drug safety

authors： Borghi C,Soldati M,Bragagni A,Cicero AFG

更新日期：2020-12-01 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：:This meeting was convened to encourage the incorporation of empirical and mechanism-based pharmacokinetic/pharmacodynamic (PK/PD) modelling into safety pharmacology to improve the predictability of nonclinical investigations for human outcomes. These technologies make use of mathematical expressions relating measured ...

journal_title：Expert opinion on drug safety

authors： Cavero I

更新日期：2007-07-01 00:00:00

abstract：:Methadone is an interesting analgesic for multiple reasons. The unique properties of the agent, low cost and widespread availability have led to increases in methadone prescribing. Despite advantages, methadone is challenging to work with, particularly in patients with high opioid requirements. Recent concerns regardi...

journal_title：Expert opinion on drug safety

authors： Swegle JM,Wensel DD

更新日期：2008-01-01 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:Alemtuzumab is a humanised anti-CD52 mAb which has recently been licensed for the treatment of relapsing multiple sclerosis in Europe. AREAS COVERED:The efficacy and safety of alemtuzumab from open label, Phase II and Phase III trials is reported. EXPERT OPINION:Alemtuzumab causes rapid and profound comp...

journal_title：Expert opinion on drug safety

authors： Willis M,Robertson NP

更新日期：2014-08-01 00:00:00

abstract：:COX-2 selective inhibitors provide analgesia and blunt inflammation while also sparing the gastrointestinal tract from classic NSAID toxicity. Therapeutic effects are thought to result from inhibition of the inflammatory COX-2 isoform. Organ sparing is considered the result of preservation of homeostatic COX-1 enzyme ...

journal_title：Expert opinion on drug safety

authors： Perazella MA

更新日期：2002-05-01 00:00:00

abstract：INTRODUCTION:Paliperidone, the major active metabolite of risperidone, is a second-generation antipsychotic that has been developed as an extended-release (ER) oral formulation and a long-acting injectable paliperidone palmitate (PP) formulation. Paliperidone has demonstrated efficacy in the reduction of acute schizoph...

journal_title：Expert opinion on drug safety

authors： Mauri MC,Reggiori A,Paletta S,Di Pace C,Altamura AC

更新日期：2017-03-01 00:00:00

abstract：INTRODUCTION:Emergency contraception (EC) is a way to significantly reduce the chance of becoming pregnant after an episode of unprotected intercourse. Considerable data support the safety of all available and emerging options for EC. Areas covered: This review presents a comprehensive summary of the literature regardi...

journal_title：Expert opinion on drug safety

authors： Lee JK,Schwarz EB

更新日期：2017-10-01 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：:Objectives: To examine the signals of bullous pemphigoid (BP) with dipeptidyl peptidase-4 inhibitors (DPP-4i) in VigiBase® and the potential role of their pharmacodynamic/pharmacokinetic parameters in the occurrence of BP. Methods: Case/non-case analyses were performed in VigiBase® to examine the signal of BP [reporti...

journal_title：Expert opinion on drug safety

authors： Carnovale C,Mazhar F,Arzenton E,Moretti U,Pozzi M,Mosini G,Leoni O,Scatigna M,Clementi E,Radice S

更新日期：2019-11-01 00:00:00

abstract：INTRODUCTION:Triamcinolone acetonide (TA) is a steroidal drug that has been widely administered intravitreally for retinal and choroidal conditions. Safety of steroidal products for intraocular use is essential because of their risk of ocular adverse events. This review comprehensively discusses the safety of intravitr...

journal_title：Expert opinion on drug safety

authors： Veritti D,Di Giulio A,Sarao V,Lanzetta P

更新日期：2012-03-01 00:00:00

abstract：:Methotrexate is a commonly prescribed antineoplastic and immune modulating compound that has gained wide acceptance in the management of rheumatoid arthritis, psoriasis, sarcoidosis and a number of neoplastic disorders. Although generally considered safe and easy to use, methotrexate has been associated with a number ...

journal_title：Expert opinion on drug safety

authors： Lateef O,Shakoor N,Balk RA

更新日期：2005-07-01 00:00:00

abstract：INTRODUCTION:Dolutegravir (DGV) is the newest integrase inhibitor approved for the treatment of HIV-1 infection in both treatment-naive and experienced adults and adolescents. This article reviews the safety of DGV for the treatment of HIV-1 infection. AREAS COVERED:The PubMed database was searched using the keywords ...

journal_title：Expert opinion on drug safety

authors： Keeshin SW,Feinberg J

更新日期：2015-01-01 00:00:00

abstract：:Recombinant activated Factor VII (rFVIIa) has been successfully used in the treatment of haemophilia A and B with associated inhibitors for some years. Activated Factor VII binds to activated platelets independently of tissue factor. The resulting stimulation of an exaggerated early thrombin burst at sites of vascular...

journal_title：Expert opinion on drug safety

authors： Wilson SJ,Bellamy MC,Giannoudis PV

更新日期：2005-05-01 00:00:00

abstract：INTRODUCTION:Pomalidomide, a derivative of thalidomide and member of the immunomodulatory drugs is licenced for use in relapsed and refractory multiple myeloma (RRMM) in Europe, USA, Canada and Japan. AREAS COVERED:This review details all published trials in which pomalidomide has been used in the treatment of myeloma...

journal_title：Expert opinion on drug safety

authors： Jones JR,Pawlyn C,Davies FE,Morgan GJ

更新日期：2016-01-01 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：: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：INTRODUCTION:Apatinib is an orally administered small-molecule vascular endothelial growth factor receptor 2 inhibitor. It has been approved and indicated for advanced gastric cancer after the failure of two or more lines of systemic therapy in China. Areas covered: This review summarizes the mechanisms, clinical appli...

journal_title：Expert opinion on drug safety

authors： Geng R,Song L,Li J,Zhao L

更新日期：2018-11-01 00:00:00

abstract：:Gemcitabine-associated thrombotic thrombocytopenic purpura is a rare complication of gemcitabine treatment with an incidence ranging from 0.015 to 1.4%. Clinically, this disease manifests as haemolytic anaemia, thrombocytopenia and renal insufficiency; hypertension and neurological and pulmonary symptoms are also know...

journal_title：Expert opinion on drug safety

authors： Saif MW,Xyla V,Makrilia N,Bliziotis I,Syrigos K

更新日期：2009-05-01 00:00:00

abstract：:The most important risk factor of oesophageal adenocarcinoma is gastro-oesophageal reflux disease. Gastro-oesophageal reflux disease is in itself a common disorder, giving bothersome symptoms. In daily clinical practice, anticholinergic drugs are believed to increase the risk of gastro-oesophageal reflux through effec...

journal_title：Expert opinion on drug safety

authors： van Soest EM,Dieleman JP,Kuipers EJ

更新日期：2008-03-01 00:00:00

abstract：BACKGROUND:Cardiovascular disease is the leading cause of mortality among adults with Type 2 diabetes. The thiazolidinediones including rosiglitazone are approved for the treatment of Type 2 diabetes on the basis of their ability to lower blood sugar and surrogate markers of cardiovascular disease. OBJECTIVES:To ascer...

journal_title：Expert opinion on drug safety

authors： Singh S,Loke YK

更新日期：2008-09-01 00:00:00

abstract：:Introduction: Lacosamide has been used in epilepsy patients in the United States, Europe and Asia since it was approved by the FDA in 2008. Many patients have benefited from this drug as a new generation of sodium channel blocker. With the worldwide use of this drug, its adverse effects have gradually emerged, especia...

journal_title：Expert opinion on drug safety

authors： Li J,Sun M,Wang X

更新日期：2020-02-01 00:00:00

abstract：BACKGROUND:E-detailing can be best described as the use of information technology in the field of pharmaceutical detailing. It is becoming highly popular among pharmaceutical companies because it maximizes the time of the sales force, cuts down the cost of detailing and increases physician prescribing. Thus, the applic...

journal_title：Expert opinion on drug safety

authors： Montoya ID

更新日期：2008-11-01 00:00:00

abstract：:Of the numerous topics discussed during the eighth annual meeting of the Safety Pharmacology (SP) Society the author identified the following key topics: i) the impact of hERG (human ether-à-go-go related gene) channel data on drug development, ii) safety evaluation of biological products, iii) opportunities and expec...

journal_title：Expert opinion on drug safety

authors： Cavero I,Safety Pharmacology Society.

更新日期：2009-03-01 00:00:00