Abstract:
INTRODUCTION:A growing number of children globally are being treated for multidrug-resistant tuberculosis (MDR-TB). The second-line injectable antituberculosis medications amikacin, kanamycin and capreomycin, traditionally a mainstay of MDR-TB treatment, cause important adverse effects including permanent sensorineural hearing loss, nephrotoxicity, electrolyte abnormalities, injection pain and local injection site complications. Areas covered: To characterize the safety and tolerability of the second-line injectables in children treated for MDR-TB, we reviewed data on the mechanism of injectable associated adverse effects, risk factors for their development, and the incidence of injectable-associated adverse effects in adults and children treated for MDR-TB. Expert opinion: Despite a substantial evidence base in adults demonstrating the frequent and potentially serious adverse effects of second-line injectables, important knowledge gaps remain. Improved characterization of the incidence of injectable-associated adverse effects will inform rational guidance on monitoring children with TB on injectables. Eliminating the need for injectables in MDR-TB treatment regimens is a high priority, and will rely on the use of novel antituberculosis TB drugs. Strategies to reduce the risk of adverse effects of injectables, if used, deserve evaluation. This includes evaluation of potentially otoprotective medications N-acetylcysteine or aspirin, high frequency hearing screening for earlier detection of ototoxicity and therapeutic drug monitoring.
journal_name
Expert Opin Drug Safjournal_title
Expert opinion on drug safetyauthors
Garcia-Prats AJ,Schaaf HS,Hesseling ACdoi
10.1080/14740338.2016.1223623subject
Has Abstractpub_date
2016-11-01 00:00:00pages
1491-1500issue
11eissn
1474-0338issn
1744-764Xjournal_volume
15pub_type
杂志文章,评审abstract::The aim of this manuscript is to report the safety profile of patients treated with ruboxistaurin mesylate (RBX; LY333531), a selective protein kinase C-beta (PKC-beta) inhibitor, for up to 4 years. Data from patients with diabetes (1396 RBX 32 mg/day; 1408 placebo) were combined from 11 placebo-controlled, double-mas...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.5.6.835
更新日期:2006-11-01 00:00:00
abstract:INTRODUCTION:Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is a novel solvent-free formulation of paclitaxel, which was developed to avoid toxicities associated with Cremophor EL® vehicle used in solvent-based paclitaxel. It is approved as monotherapy for treatment of metastatic breast cancer (MBC) in Europe a...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.893293
更新日期:2014-04-01 00:00:00
abstract:INTRODUCTION:Pembrolizumab is a highly selective fully human immunoglobulin 4 monoclonal antibody against programmed death 1 (PD-1). Phase II and III trials have demonstrated that pembrolizumab has antitumor activity in previously treated patients with advanced gastric cancer (AGC). AREA COVERED:Pembrolizumab was appr...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2020.1805428
更新日期:2020-09-01 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
pub_type: 杂志文章,评审
doi:10.1517/14740338.2010.517192
更新日期:2011-01-01 00:00:00
abstract:INTRODUCTION:In 1998, high-dose interleukin-2 (IL-2) was the first immunotherapy approved for the treatment of metastatic melanoma based on durable objective responses documented in a subset of patients but widespread utilization was limited by significant toxicity. Advances in targeted therapy and the emergence of T c...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1382472
更新日期:2017-12-01 00:00:00
abstract:INTRODUCTION:Lanreotide autogel is a synthetic somatostatin analogue which has been FDA and EMA approved for unresectable, well to moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumor. Its action is mediated by its affinity to somatostatin receptors, especially sst2 and ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2019.1559294
更新日期:2019-01-01 00:00:00
abstract::Anthracyclines are among the most active chemotherapeutic agents in cancer treatment. Although infrequent, cumulative dose-dependent cardiotoxicity is nevertheless a significant side effect of this therapy resulting in reduced cardiac reserve or even frank cardiac failure. Although used in several types of malignancy,...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.6.3.315
更新日期:2007-05-01 00:00:00
abstract:INTRODUCTION:Since calcitonin gene-related peptide (CGRP) plays an important role in the pathophysiology of migraine via the activation of the trigeminovascular system, the newest prophylactic treatments directly block CGRP or its receptor. However, the safety of these novel antimigraine drugs is not yet sufficiently e...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2020.1811229
更新日期:2020-10-01 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
pub_type: 临床试验,杂志文章
doi:10.1517/14740338.2012.653340
更新日期:2012-05-01 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
pub_type: 杂志文章
doi:10.1080/14740338.2019.1604682
更新日期:2019-05-01 00:00:00
abstract:INTRODUCTION:Over the past decade, increased prescription supply has facilitated an epidemic of nonmedical use of controlled substances, including predominantly opioids, as well as benzodiazepines, z-hypnotics, and stimulants. Areas covered: More recently, misuse of noncontrolled prescriptions, such as gabapentin, has ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2017.1390081
更新日期:2018-05-01 00:00:00
abstract:INTRODUCTION:In the past two decades, the number of women with autoimmune and inflammatory diseases experiencing a pregnancy has significantly increased in parallel with the enormous advances in the diagnosis and management of these disorders. However, information regarding the safety of immunosuppressive agents comes ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.951326
更新日期:2014-12-01 00:00:00
abstract:INTRODUCTION:Gastrointestinal bleeding (GIB) is a major problem in patients on oral anticoagulation therapy. This issue has become even more pressing since the introduction of direct oral anticoagulants (DOACs) in 2009. Areas covered: Here we review current evidence related to GIB associated with oral anticoagulants, f...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1325870
更新日期:2017-06-01 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
pub_type: 杂志文章
doi:10.1517/14740338.2013.744965
更新日期:2013-01-01 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
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1351538
更新日期:2017-09-01 00:00:00
abstract:INTRODUCTION:Anticonvulsant hypersensitivity syndrome (AHS) is a rare but potentially life-threatening adverse drug reaction, primarily associated with phenytoin, phenobarbital and carbamazepine. It is characterized by a triad of fever, skin eruption and internal organ involvement (usually liver), which occur two to ei...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2012.705828
更新日期:2012-09-01 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
pub_type: 杂志文章,评审
doi:10.1517/14740338.4.4.723
更新日期:2005-07-01 00:00:00
abstract:BACKGROUND:Critically ill patients receiving parenteral drugs are at an increased risk of exposure to various excipients administered simultaneously and at increased amounts. Hence, we carried out the present study. RESEARCH DESIGN AND METHODS:Patients admitted in the adult, pediatric, and neonatal intensive care unit...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2020.1805431
更新日期:2020-12-01 00:00:00
abstract::Ixabepilone is a semisynthetic analogue of epothilone B, a novel microtubule-stabilizing agent. Preclinical data suggest that its mechanisms of actions are different from those of the most commonly used microtubule-stabilizing agent, paclitaxel. This information in addition to the cytotoxicity of this drug in taxane-r...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740330802655538
更新日期:2009-01-01 00:00:00
abstract:INTRODUCTION:Epidural steroid injections (ESI) are a commonly utilized treatment for cervical and lumbar radicular pain. All medical procedures and medications carry an inherent level of risk, that must be balanced with the effectiveness of the treatment to determine the risk to benefit ratio for a patient. AREAS COVE...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2016.1184246
更新日期:2016-08-01 00:00:00
abstract:BACKGROUND:Gallstone disease is common in Western countries. Statins reduce biliary cholesterol secretion and have anti-inflammatory effects, suggesting that they may play a role in reducing the incidence of surgically treated gallstone disease. AIM:To examine a potential association between statin administration and ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2010.485190
更新日期:2010-07-01 00:00:00
abstract::Black cohosh (Actaea racemosa/Cimicifuga racemosa) is a North American perennial plant that has been used for traditional medicinal purposes by the native Indian population. Its modern day application is the treatment of menopausal symptoms. Unlike conventional non-herbal medications, herbal preparations have not been...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.3.6.615
更新日期:2004-11-01 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
pub_type: 杂志文章,评审
doi:10.1517/14740338.7.5.579
更新日期:2008-09-01 00:00:00
abstract:OBJECTIVE:The aim of this study is to evaluate the safety of cephalosporins, based on utilization and adverse drug events (ADEs). METHODS:This is a retrospective study using data on cephalosporins, obtained from Yangtze River hospital drug information and the Wuhan adverse drug reactions monitoring center database, fr...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,多中心研究
doi:10.1517/14740338.2012.699037
更新日期:2012-09-01 00:00:00
abstract::Introduction: Secukinumab is a fully human monoclonal antibody which targets and neutralizes interleukin (IL)-17A, a cytokine that plays an important role in the pathophysiology of ankylosing spondylitis (AS). Secukinumab is the first IL-17A inhibitor approved for the treatment of AS. Areas covered: This paper aimed t...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2021.1851363
更新日期:2021-01-20 00:00:00
abstract:INTRODUCTION:Aripiprazole is a third generation antipsychotic approved by the US Food and Drug Administration (FDA) for the treatment of schizophrenia. Aripiprazole is available as oral and long-acting injectable (LAI) depot formulations, with a unique mechanism of action comprising partial D2 and serotonin 5-HT1A agon...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2020.1832990
更新日期:2020-12-01 00:00:00
abstract::Objetive: This study evaluated the results of treatment adherence scales in two cohorts of patients with diabetes mellitus treated either with human or analogue insulins. METHODS:A cohort study was conducted in diabetes mellitus patients older than 18 that were being treated with human or analogue insulins. Two instr...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2017.1273346
更新日期:2017-02-01 00:00:00
abstract::The widespread application of protocols using gonadotropin-releasing hormone (GnRH) agonists or antagonists in assisted reproduction treatment has led to an increasing number of pregnancies exposed to these drugs. This issue has raised scepticism as to the safety of these medications, concerning both pregnant women an...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.3.1.39
更新日期:2004-01-01 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
pub_type: 杂志文章
doi:10.1080/14740338.2020.1836151
更新日期:2020-12-01 00:00:00
abstract:BACKGROUND:Clinical data on the long-term safety and efficacy of infliximab on psoriatic patients who are older than 65 years are limited. OBJECTIVES:The aim is to report the long-term efficacy, safety and tolerance of infliximab in geriatric patients. METHODS:This was a retrospective study conducted at the Departmen...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2016.1226279
更新日期:2016-11-01 00:00:00