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Expert Opinion on Drug Safety

María Molina-Vega, Araceli Muñoz-Garach, José C Fernández-García, Francisco J Tinahones
Type 2 diabetes (T2D), a multifactorial and chronic disease, requires in an elevated percentage of patients the association of several antidiabetic drugs to achieve optimal glycemic control. Dipeptidyl peptidase-4 inhibitors (DPP-4i) and sodium-glucose cotransporter inhibitors (SGLT2i) are new classes of oral antidiabetic drugs developed over the last years. Areas covered: This paper summarizes the safety of DPP-4i and SGLT2i combination therapies. Relevant studies were identified through searches in PubMed...
July 12, 2018: Expert Opinion on Drug Safety
Tesfahun C Eshetie, Tuan A Nguyen, Marianne H Gillam, Lisa M Kalisch Ellett
People with dementia may be particularly susceptible to medication related problems for various reasons. They include progressive cognitive decline, high sensitivity to the effect of medications on cognition and memory and increased likelihood of comorbidities. Areas covered: This paper aimed to review current literature on the frequency and the types of medication related problems, and their contribution to hospital admission in people with dementia. Literature searches were conducted using key search terms of dementia and medication related problems...
July 11, 2018: Expert Opinion on Drug Safety
Jérémy Lardon, Florelle Bellet, Rim Aboukhamis, Hadyl Asfari, Julien Souvignet, Marie-Christine Jaulent, Marie-Noëlle Beyens, Agnès Lillo-Le Louët, Cédric Bousquet
BACKGROUND: Social media are currently considered as a potential complementary source of knowledge for drug safety surveillance. Our primary objective was to estimate the frequency of adverse drug reactions (ADRs) experienced by Twitter users. Our secondary objective was to determine whether tweets constitute a valuable and informative source of data for pharmacovigilance purposes, despite limitations on character number per tweet. RESEARCH DESIGN AND METHODS: We selected a list of 33 drugs subject to careful monitoring due to safety concern in France and Europe, and extracted tweets using the streaming API from September 30, 2014 to April 5, 2015...
July 10, 2018: Expert Opinion on Drug Safety
Omar Abdel-Rahman
BACKGROUND: The purpose of the current study is to assess the predictors of skeletal-related events (SREs) among advanced cancer patients with bone metastases treated with zoledronic acid within a randomized study. RESEARCH DESIGN AND METHODS: This is a secondary analysis of patient-level data of advanced cancer patients with bone metastases who were treated with monthly zoledronic acid in the NCT00330759 clinical trial. RESULTS: A total of 702 patients were included in the current analysis...
July 4, 2018: Expert Opinion on Drug Safety
D Formica, J Sultana, P M Cutroneo, S Lucchesi, R Angelica, S Crisafulli, Y Ingrasciotta, F Salvo, E Spina, G Trifirò
Adverse drug reactions (ADRs) are an important cause of morbidity and mortality worldwide. They are associated with healthcare costs due to hospital admissions or prolonged length of stay (LOS), as well as additional interventions. The aim of this study was to conduct a systematic review of observational studies to evaluate the economic impact of preventable ADRs. Areas covered: Published observational research investigating the cost of preventable ADRs in Western countries (limited to the US and European countries)...
June 28, 2018: Expert Opinion on Drug Safety
Alessandro Cuomo, Giuseppe Maina, Stephen M Neal, Graziella De Montis, Gianluca Rosso, Simona Scheggi, Bruno Beccarini Crescenzi, Simone Bolognesi, Arianna Goracci, Anna Coluccia, Fabio Ferretti, Andrea Fagiolini
The World Health Organization recommends newborns to be breastfed but this may be challenging if the mother needs to be treated for depression, since strong evidence to inform treatment choice is missing. Areas covered: We provide a critical review of the literature to guide clinicians who are considering sertraline for the management of depression during postpartum. Expert opinion: Sertraline is one of the safest antidepressants during breastfeeding. In most cases, women already taking sertraline should be advised to breastfeed and continue the medication...
June 21, 2018: Expert Opinion on Drug Safety
Xuemei Zhang, Rui Niu, Bianling Feng, Jiadong Guo, Ying Liu, Xinyu Liu
BACKGROUND: Although China's adverse drug reaction (ADR) reporting and monitoring has developed rapidly, many challenges remain. This study assessed ADR monitoring and reporting in China and identified monitoring problems. RESEARCH DESIGN AND METHODS: A cross-sectional survey was conducted of ADR reporting institutions in six Chinese provinces in April-December 2014. Questionnaires assessed ADR systems, basic resources, and pharmacovigilance activity. RESULTS: Of 720 questionnaires distributed, the response rate was 81...
June 14, 2018: Expert Opinion on Drug Safety
Philip Hazell
No abstract text is available yet for this article.
May 23, 2018: Expert Opinion on Drug Safety
Matteo Bassetti, Alessandro Russo, Alessia Carnelutti, Alessandro La Rosa, Elda Righi
Infections due to multidrug-resistant (MDR) bacteria are burdened by high mortality rates. The development of new compounds to face the global threat of resistance is urgently needed. Combination regimens including "old" high-dose antimicrobials are currently limited by the risk of toxicity, resistance selection, and reduced efficacy. Following the Infectious Diseases Society of America call to develop 10 new antibacterials by 2020, new molecules are currently under development or have become available for use in clinical practice...
July 2018: Expert Opinion on Drug Safety
M Galluzzo, S D'Adamio, E Campione, L Bianchi, M Talamonti
Guselkumab is a fully human monoclonal IgG1λ antibody for the treatment of plaque psoriasis that inhibits interleukin (IL)-23p19 subunit, reducing the proliferation of type 17 helper T (Th-17) cells and thus production of Th-17-derived pro-inflammatory cytokines, especially IL-17 and IL-22. Areas covered: In the following article, the mechanism of action and mainly the efficacy and safety profile of guselkumab available from results of trials will be discussed. We summarized these data after a literature review including PubMed search, relating proceedings and abstracts from relevant international conferences, assessment reports from European and United States regulatory agencies and treatment guidelines up to April 2018...
July 2018: Expert Opinion on Drug Safety
Julio Ramírez, Juan D Cañete
The anti-interleukin-1 receptor antagonist, anakinra, was approved for the treatment of rheumatoid arthritis (RA) more than 12 years ago. However, its adverse effects are not well known. Areas covered: We review the safety profile of anakinra, analyzing clinical trials, observational studies, and registry data. Expert opinion: Due to its lower efficacy compared with other biological therapies approved for RA and its daily subcutaneous administration, anakinra is used only marginally for the treatment of RA...
July 2018: Expert Opinion on Drug Safety
Alessandro Giollo, Lesley-Anne Bissell, Maya H Buch
Rheumatoid arthritis (RA) is associated with a heightened risk of cardiovascular disease (CVD), with both traditional CV risk factors and inflammation contributing to this risk. Areas covered: This review highlights the burden of CVD in RA and associated traditional CV risk factors, including the complexity of dyslipidemia in RA and the so-called 'lipid paradox.' Furthermore, the recognized RA-disease-specific factors associated with higher risk of CVD and the role of systemic inflammation in the pathogenesis of CVD in RA will be addressed...
July 2018: Expert Opinion on Drug Safety
Xiaolu Nie, Ying Zhang, Zehao Wu, Lulu Jia, Xiaoling Wang, Sinéad M Langan, Eric I Benchimol, Xiaoxia Peng
OBJECTIVES: To appraise the reporting quality of studies which concerned linezolid-related thrombocytopenia referring to REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement. METHODS: Medline, Embase, Cochrane library and were searched for observational studies concerning linezolid-related thrombocytopenia using routinely collected health data from 2000 to 2017. Two reviewers screened potential eligible articles and extracted data independently...
July 2018: Expert Opinion on Drug Safety
Antonio Riccardo Buonomo, Emanuela Zappulo, Giulio Viceconte, Riccardo Scotto, Guglielmo Borgia, Ivan Gentile
Alemtuzumab is a monoclonal anti CD-52 antibody recently approved for use in relapsing-remitting multiple sclerosis(MS). Given that the targeted antigen is primarily expressed on B and T lymphocytes, the administration of this biological drug is associated with rapid but protracted peripheral lymphopenia. Areas covered: The impact on infective risk of this immune impairment is still to be fully understood. In this review, we attempt to summarize all the available literature concerning opportunistic infections occurring in patients with MS receiving alemtuzumab...
July 2018: Expert Opinion on Drug Safety
Bharati Kochar, Hans H Herfarth
Teduglutide is an analog of glucagon-like peptide 2 (GLP-2) which is approved for the treatment of patients with short bowel syndrome (SBS) who are dependent on parenteral support. Areas covered: Short bowel syndrome is a rare condition that can result from extensive resection of small bowel, congenital abnormalities, or inflammatory conditions that leads to poor nutrient processing capacity of the intestine. In this review, the safety reported in controlled clinical trials and real-world experience with teduglutide are presented in depth...
July 2018: Expert Opinion on Drug Safety
Massimo Breccia, Fabio Efficace, Alessandra Iurlo, Luigiana Luciano, Elisabetta Abruzzese, Antonella Gozzini, Patrizia Pregno, Mario Tiribelli, Gianantonio Rosti, Giorgio Minotti
In spite of the proven efficacy of the tyrosine kinase inhibitor (TKI), imatinib, in chronic myeloid leukemia (CML), many patients develop intolerance and discontinue therapy in the long-term. Second-generation TKIs (dasatinib, nilotinib, bosutinib) and the third-generation TKI, ponatinib, have added opportunities but also complexity in the settings of CML treatment. Areas covered: Different definitions of intolerance have been used through several clinical trials, making the published data non homogenous. In most cases, only the severity of acute adverse events (AEs), graded by conventional scales such as Common Terminology Criteria for Adverse Events, was reported...
June 2018: Expert Opinion on Drug Safety
Fabio Carfagna, Lucia Del Vecchio, Giuseppe Pontoriero, Francesco Locatelli
Hyperphosphatemia is common in late stages of chronic kidney disease and is often associated with elevated parathormone levels, abnormal bone mineralization, extra-osseous calcification, and increased risk of cardiovascular events and death. Several classes of oral phosphate binders are available to help control plasma phosphorus levels. Although effective at lowering serum phosphorus, they all have safety, tolerability, and compliance issues that need to be considered when selecting which one to use. Areas covered: This paper reviews the most established treatment options for hyperphosphatemia, in patients with chronic kidney disease, focusing on the new inhibitors of active phosphate absorption...
June 2018: Expert Opinion on Drug Safety
Julieta González, Matías Quiroga, Vicente Escudero-Vilaplana, Roberto Collado-Borrell, Ana Herranz-Alonso, María Sanjurjo Sáez
BACKGROUND: Oral antineoplastic agents (OAA) have reached 30-50% of all antineoplastic treatments. Although they seem safer than parenteral therapy, many severe problems can occur if the dose is not adequately adjusted in special situations. Our objective is to create a comprehensive guide with dosage adjustment recommendations for OAA in cases of renal and hepatic impairment and hematologic toxicities. RESEARCH DESIGN AND METHODS: We analyzed all OAA approved by EMA in July 2017...
June 2018: Expert Opinion on Drug Safety
Helen Koechlin, Joe Kossowsky, Jens Gaab, Cosima Locher
SSRIs and SNRIs are prescribed as first-line pharmacological treatment for common mental disorders in children and adolescents. Despite their efficacy, they have a high risk for adverse events and exhibit a substantial placebo response. This editorial provides some background on the current evidence on the topic and suggests to carefully weigh the benefits of SSRIs and SNRIs against their potential harms. Therefore, the authors present two different set of conclusions - one for clinical practice, and one for future research designs...
June 2018: Expert Opinion on Drug Safety
Ramón García-Sanz, Cristina Jiménez, Verónica González De La Calle, María Eugenia Sarasquete
Waldenström's macroglobulinemia (WM) is a B-cell lymphoproliferative disease with serum IgM monoclonal component and bone marrow infiltration by lymphoplasmacytic lymphoma. Traditional therapy was based on that regimens used for closely related entities, such as chronic lymphocytic leukemia or multiple myeloma. This resulted in a lack of drugs specifically approved for WM, until the discovery of the Bruton Tyrosine Kinase (BTK) inhibitors. Areas covered: Two main therapeutic attitudes are possible: (1) conventional therapies based on combinations with alkylating agents or proteasome inhibitors with steroids and anti-CD20 monoclonal antibodies or (2) new approaches with BTK inhibitors, usually alone...
June 2018: Expert Opinion on Drug Safety
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