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 members and expert consultants to evaluate the safety of antidepressants in children and adolescents. The committee reviewed a meta-analysis of antidepressant use in pediatric patients and concluded that there was a causal link between pediatric antidepressant use and suicidality. In response, the FDA mandated that a 'black box' warning be added to the prescribing and promotional information for all antidepressants. The warning specifically states 'antidepressants increase the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders'. Interestingly, the FDA tempered the warning with the following statement: 'Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide'. Therefore, in effect, the FDA has warned that both untreated depression and treatments for depression lead to suicidality. Now, 4 years later, the repercussions of the black box warning are becoming evident.
journal_name
Expert Opin Drug Safjournal_title
Expert opinion on drug safetyauthors
Gören JLdoi
10.1517/14740338.7.3.223subject
Has Abstractpub_date
2008-05-01 00:00:00pages
223-5issue
3eissn
1474-0338issn
1744-764Xjournal_volume
7pub_type
社论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::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
pub_type: 社论
doi:10.1517/14740330902942299
更新日期:2009-05-01 00:00:00
abstract:INTRODUCTION:Nephrotoxicity is generally considered as the most clinically significant adverse reaction of amphotericin B, and has been reported in up to 80% of amphotericin B recipients during the first 2 weeks of treatment. Numerous experimental and clinical investigations have been performed over the past 4 decades,...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2012.721775
更新日期:2012-11-01 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
pub_type: 杂志文章,评审
doi:10.1517/14740330903099636
更新日期:2009-09-01 00:00:00
abstract::Background: This study aimed to measure the association of various H1-antihistamines (H1A) with Torsade de Pointes (TdP), and present a comprehensive overview of H1A-induced TdP cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: All H1A-induced TdP cases (n = 406) were ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2021.1846717
更新日期:2021-01-01 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
pub_type: 杂志文章,评审
doi:10.1517/14740338.4.5.879
更新日期:2005-09-01 00:00:00
abstract:INTRODUCTION:Reslizumab, a humanized mAb against IL-5, reduces the number of eosinophils in the blood and lungs. Based on efficacy and safety data from pivotal RCTs, reslizumab had been approved for use as an add-on maintenance treatment of severe asthma with an eosinophilic phenotype in adults who have a history of ex...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2018.1446940
更新日期:2018-04-01 00:00:00
abstract::This review aims to give an updated overview of the worldwide situation of off-label and unlicensed drug use in the paediatric field, also taking into account the safety of this kind of treatment. A Medline and Embase search was performed between 1990 and 2006 and a total of 52 studies were identified and included in ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.5.5.703
更新日期:2006-09-01 00:00:00
abstract:INTRODUCTION:Acne is a common skin condition of the pilosebaceous units that affects the young and old, ranges from moderate to severe and can be treated with an array of options. Topical retinoids are the initial treatment for acne due to their ability to treat comedones, the starting point of acne. AREAS COVERED:Taz...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2016.1117605
更新日期:2016-01-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to investigate whether the use of statins was associated with a decreased risk of gallstone disease. METHODS:We conducted a population-based case-control study in Taiwan. Cases consisted of all patients who were aged 50 years and older and had a first-time diagnosis of gallstone dis...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2012.653560
更新日期:2012-05-01 00:00:00
abstract::An unprecedented interest in biomarker development has arisen from the increasing use of genomic information and high-throughput technologies in the field of drug development. Monitoring global cellular responses to perturbation due to disease, drug treatment or toxicity is achieved using molecular profiling methods s...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/eods.3.2.137.27344
更新日期:2004-03-01 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: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
pub_type: 杂志文章,评审
doi:10.1080/14740338.2019.1597849
更新日期:2019-04-01 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
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.928691
更新日期:2014-08-01 00:00:00
abstract::The use of warfarin in the elderly, particularly for stroke prevention in chronic atrial fibrillation, is steadily increasing. Although the benefits of warfarin are greatest in the elderly, so are the risk of adverse outcomes and the difficulties of anticoagulant management. Clinical systems need to improve to counter...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.5.3.417
更新日期:2006-05-01 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::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
pub_type: 杂志文章
doi:10.1080/14740338.2019.1668373
更新日期:2019-11-01 00:00:00
abstract:BACKGROUND:Possible relationship between drug exposure and multiple sclerosis (MS) development is insufficiently investigated, and further challenged by the incomplete understanding of MS etiopathogenesis. The study aims to investigate whether drug exposure could contribute to MS, by analyzing worldwide spontaneous rep...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2018.1506763
更新日期:2018-09-01 00:00:00
abstract:OBJECTIVE:To investigate whether the use of statins was associated with kidney cancer risk. METHODS:We conducted a population-based case-control study in Taiwan. Cases consisted of all patients who were aged 50 years and older, and had a first-time diagnosis of kidney cancer for the period between 2005 and 2009. The c...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2012.678831
更新日期:2012-07-01 00:00:00
abstract::Objectives: To assess the risk of adverse events (AEs) associated with brentuximab vedotin in lymphoma patients.Methods: Articles were retrieved from PubMed, Cochrane, and Clinicaltrials Databases to identify randomized controlled trials (RCTs) comparing brentuximab vedotin with non-brentuximab vedotin in lymphoma pat...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,meta分析
doi:10.1080/14740338.2020.1718103
更新日期:2020-05-01 00:00:00
abstract::In a very short time, COX-2 enzyme inhibitors have gone from the darlings to the pariahs of the pharmaceutical industry. These drugs were developed based on the hypothesis whereby selective inhibition of the COX enzyme would lead to reduction in pain and inflammation without associated gastrointestinal and bleeding ri...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.4.6.1005
更新日期:2005-11-01 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
pub_type: 杂志文章,评审
doi:10.1517/14740338.2011.579899
更新日期:2011-09-01 00:00:00
abstract:INTRODUCTION:Niacin is one of the oldest drugs used in the treatment of dyslipidemia. Previously its use has been limited because of excessive flushing. Now an agent laropiprant (LRP) has been developed, which blocks the flushing pathway. Therefore, it is time to collate available information to assess the safety and t...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2011.638281
更新日期:2012-01-01 00:00:00
abstract:OBJECTIVE:Further understand the safety profile of celecoxib and provide safety information for important adverse events (AEs). METHODS:Analysis of randomized controlled trials from the Pfizer clinical trial repository (final study reports completed by 31 July 2011) in which celecoxib was compared with placebo or non-...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,meta分析
doi:10.1517/14740338.2013.780595
更新日期:2013-07-01 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
pub_type: 杂志文章,评审
doi:10.1517/14740338.2015.973845
更新日期:2015-01-01 00:00:00
abstract:INTRODUCTION:Basiliximab is a chimeric monoclonal antibody directed against the alpha chain of interleukin-2 receptor (IL-2R). When administered intravenously at a dosage of 20 mg at the time of transplantation and 4 days later, basiliximab saturates the alpha chain of IL-2R for 4 weeks. AREAS COVERED:This review eval...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,随机对照试验
doi:10.1517/14740338.2014.861816
更新日期:2014-03-01 00:00:00
abstract::Objectives: Sensory adverse drug reactions (ADRs) are generally expected to be transient in nature. However, spontaneous reports describe frequently these events as long-lasting or unresolved. In this study, the authors reviewed the Eudravigilance publicly accessible database to describe the volume and expectedness of...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2019.1676724
更新日期:2019-12-01 00:00:00
abstract::Introduction: Fixed-dose combination (FDC) medicines contain more than one approved active pharmaceutical ingredient (API), are manufactured as a fixed-dose and packed in a single dosage form. FDCs have been drawing attention from the pharmaceutical industries because of the government's ban on 328 irrational FDCs in ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2019.1651292
更新日期:2019-10-01 00:00:00
abstract:INTRODUCTION:There is a continuing need for an immunosuppressive therapy that offers a high benefit-risk profile for renal transplant recipients, supporting long-term patient and graft survival while minimizing cumulative nephrotoxicity and other side effects. Belatacept , the first biological agent developed for prima...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2013.748747
更新日期:2013-01-01 00:00:00
abstract::Bone morphogenetic proteins (BMPs) have been extensively studied since the discovery of agents within bone that could induce bone formation at ectopic sites by Urist in the 1960s. Extensive preclinical research has been carried out showing the efficacy of these products in promoting bone healing. Clinical trials are e...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.4.1.75
更新日期:2005-01-01 00:00:00