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Expert Opinion on Drug Safety

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https://www.readbyqxmd.com/read/29025271/psychotropic-drugs-and-cyp2d6-in-late-life-psychiatric-and-neurological-disorders-what-do-we-know
#1
Davide Seripa, Madia Lozupone, Eleonora Stella, Giulia Paroni, Paola Bisceglia, Maddalena La Montagna, Grazia D'onofrio, Carolina Gravina, Maria Urbano, Maria Giovanna Priore, Angela Lamanna, Antonio Daniele, Antonello Bellomo, Giancarlo Logroscino, Antonio Greco, Francesco Panza
Late-life psychiatric and neurological disorders (LLPND) are interesting models to understand the potential role of pharmacogenetics in drug management, since several pharmacological approaches for treating LLPND have proven to be ineffective or deleterious, thus resulting in therapeutic failures (TF) and adverse drug reactions (ADR). Common variants in the genes encoding the cytochrome P450 (CYP) enzyme system, the 'engine room' of drug metabolism, together with well-known age-related increased polypharmacy also contributed to the prevalence of TF and ADR observed in these patients, also rising number and time of hospital readmissions and rate of institutionalizations...
October 12, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29022425/biologics-in-pediatric-psoriasis-efficacy-and-safety
#2
Sunil Dogra, Rahul Mahajan
Introduction Childhood psoriasis is a special situation that is a management challenge for the treating dermatologist. As is the situation with traditional systemic agents, which are commonly used in managing severe psoriasis in children, the biologics are being increasingly used in the recalcitrant disease despite limited data on long term safety. Areas covered - We performed an extensive literature search to collect evidence-based data on the use of biologics in pediatric psoriasis. The relevant literature published from 2000 to September 2017 was obtained from PubMed, using the MeSH words 'biologics', 'biologic response modifiers' or 'treatment of pediatric/childhood psoriasis'...
October 12, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28984477/pediatric-pharmacoepidemiology-safety-and-effectiveness-of-medicines-for-adhd
#3
Antonio Clavenna, Maurizio Bonati
Attention-deficit hyperactivity disorder (ADHD) is a common neurobehavioral disorder in children and adolescents that comprises core symptoms of developmentally inappropriate levels of inattention and/or hyperactivity and impulsivity. Stimulant (methylphenidate, amphetamines) and non stimulant (atomoxetine, clonidine and guanfacine) are the treatment usually prescribed for ADHD. Area covered: This review covers the safety of ADHD medications in children and adolescents. MEDLINE, EMBASE and PsycINFO databases were searched with the aim to retrieve prospective studies that monitored the incidence of adverse events (AEs) in children receiving drug therapy for ADHD...
October 12, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28988524/safety-of-hormonal-contraception-for-obese-women
#4
Ana Luiza L Rocha, Rayana R Campos, Marina M S Miranda, Laio B P Raspante, Márcia M Carneiro, Carolina S Vieira, Fernando M Reis
Obese women have special safety requirements for contraceptive choice, but the evidence supporting such decision is dispersed and sometimes conflicting. Despite being effective, well tolerated and safe for most women, hormonal contraceptives are underused by obese women due to fear of contraceptive failure, weight gain and venous thrombosis. Areas covered: We performed a comprehensive literature search to identify studies about hormonal contraception in overweight and obese women, including safety concerns...
October 11, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28934557/a-safety-evaluation-of-empagliflozin-plus-linagliptin-for-treating-type-2-diabetes
#5
Baptist Gallwitz
Dipeptidyl-peptidase-IV inhibitors (DPP-4i) and sodium-glucose-transporter-2 inhibitors (SGLT-2i) are oral antidiabetic drugs that improve glycemic parameters and possess a very low intrinsic hypoglycemia risk and favorable cardiovascular data. Areas covered: An overview on the clinical studies investigating the combination therapy with the DPP-4i linagliptin and the SGLT-2i empagliflozin is given. The clinical evidence for the efficacy and safety of free combinations as well as for their fixed dose combinations is presented...
October 11, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28994319/a-review-of-clinical-safety-data-for-sumatriptan-nasal-powder-administered-by-a-breath-powered-exhalation-delivery-system-in-the-acute-treatment-of-migraine
#6
Stephen D Silberstein
Introduction AVP-825 (sumatriptan nasal powder) is an FDA-approved intranasal medication delivery system containing low-dose sumatriptan powder for acute treatment of migraine with or without aura in adults. AVP-825 utilizes unique nasal anatomy features to avoid limitations of other intranasal delivery methods. Areas covered Literature search terms: "AVP-825", "sumatriptan nasal powder", "intranasal sumatriptan", "sumatriptan safety", "sumatriptan acute migraine". Pharmacokinetic, Phase 2/3 studies, reviews (AVP-825) and metanalyses/reviews (sumatriptan) were evaluated...
October 10, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28988500/a-safety-evaluation-of-evolocumab
#7
Eli M Roth
Evolocumab is an injectable, fully human monoclonal antibody and a member of the newest class of low density lipoprotein cholesterol (LDL-C) lowering agents called proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. The PCSK9 inhibitors are the most significant advance in lipid therapy since the introduction of the first statin 30 years ago. Areas covered: The PCSK9 monoclonal antibodies have demonstrated a consistently high LDL-C lowering efficacy with and without statins and/or other lipid lowering therapies (LLT)...
October 9, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28985090/policies-to-mitigate-nonmedical-use-of-prescription-medications-how-should-emerging-evidence-of-gabapentin-misuse-be-addressed
#8
Alyssa M Peckham, Kathleen A Fairman, David A Sclar
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 been detected. Gabapentin misuse has been associated with drug-related harm and increased healthcare service utilization in a few studies, including a recent large-sample analysis of commercially insured enrollees in the United States (U...
October 6, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28960089/efficacy-and-safety-of-dronedarone-in-the-treatment-of-patients-with-atrial-fibrillation
#9
Mohammed Hasan Khan, Yogita Rochlani, Wilbert S Aronow
Dronedarone, a derivative of amiodarone with structural modifications, was designed to have similar electrophysiological properties with a less toxic profile. Areas covered: Brief overview of the pharmacology of dronedarone followed by a summary of randomized clinical trials testing the efficacy of dronedarone in maintaining normal sinus rhythm and clinical outcomes associated with these trials. In depth discussion and commentary on trial findings which may seem contradictory at first approach and brief discussion of post-marketing surveillance studies...
October 6, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28976217/drugs-approved-for-the-treatment-of-multiple-sclerosis-review-of-their-safety-profile
#10
Fabiana Auricchio, Cristina Scavone, Daniela Cimmaruta, Gabriella di Mauro, Annalisa Capuano, Liberata Sportiello, Concetta Rafaniello
Multiple sclerosis (MS) is a chronic immune-mediated inflammatory disorder of the brain and spinal cord characterized by inflammation, demyelination, and axonal degeneration. Area covered: Even though the pharmacological armamentarium for MS treatment is considerably improved in the last 20 years, safety data especially for the second-line and innovative treatments are lacking. In order to analyze the safety profile of drugs used for the treatment of MS, a literature review of pre-marketing, post-marketing studies and case reports was performed...
October 4, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28942678/fetal-programming-of-mental-health-by-acetaminophen-response-to-the-smfm-statement-prenatal-acetaminophen-use-and-adhd
#11
Jørn Olsen, Zeyan Liew
A number of studies indicate that acetaminophen taken during pregnancy may have a programming effect on the fetal brain development. The potential adverse consequences may only surface to clinical detection years later. Should we act on these findings now or do we wait for additional evidence? Areas covered: We argue for action inspired by these well analyzed studies that are based on five prospective cohorts data collected from different countries. Several analytical options have been employed especially to address confounding, and all analyses have consistently suggested that confounding alone is an unlikely explanation for this disturbing observation...
September 23, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28934555/cardiovascular-effects-of-methadone-and-concomitant-use-of-diazepam-during-methadone-maintenance-treatment-induction-low-concentration-risk
#12
Vesna Mijatović, Isidora Samojlik, Stojan Petković, Saša Vukmirović, Arsen Uvelin, Aleksandra Dickov
Background The aim is to evaluate the role of diazepam concentrations in development of low-concentration-methadone-associated QTc prolongation in patients with opioid use disorder during methadone maintenance treatment (MMT) induction. Research design and methods Individuals with addiction disorder on MMT were studied before the beginning of MMT and after one and six months of MMT. Serum concentrations of methadone, diazepam, electrolytes and ECG were analyzed. Results Thirty patients were enrolled. The mean methadone concentration at time points was 177±119 ng/ml and 343±182 ng/ml, while the mean diazepam concentration was 561±437 ng/ml and 1045±933 ng/ml...
September 21, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28929820/high-dose-interleukin-2-il-2-for-the-treatment-of-melanoma-safety-considerations-and-future-directions
#13
Stephen Marabondo, Howard L Kaufman
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 cell checkpoint inhibitors, which can generally be given in the ambulatory setting, have further limited consideration of IL-2 for melanoma patients and the role of IL-2 in the current landscape of melanoma treatment is uncertain...
September 20, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28920492/recommendations-on-managing-lenvatinib-and-everolimus-in-patients-with-advanced-or-metastatic-renal-cell-carcinoma
#14
E Grande, H Glen, J Aller, G Argenziano, M J Lamas, P Ruszniewski, J L Zamorano, K Edmonds, S Sarker, M Staehler, J Larkin
There are several second-line treatment options for patients with renal cell carcinoma after first-line failure of a tyrosine kinase inhibitor, especially with the recent approvals of cabozantinib, nivolumab, and the lenvatinib plus everolimus combination. A lack of reliable biomarkers and an overall lack of prospective head-to-head comparisons make it a challenge to choose a second-line treatment in the clinic. Areas covered: In this review/meta-opinion, we describe the safety profile of the lenvatinib plus everolimus combination in renal cell carcinoma...
September 18, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28902525/lurasidone-efficacy-and-safety-in-the-treatment-of-psychotic-and-mood-disorders
#15
Maurizio Pompili, Claudio Verzura, Giada Trovini, Andrea Buscajoni, Giulia Falcone, Stefano Naim, Adele Nardella, Serena Sorice, Ross J Baldessarini, Paolo Girardi
Lurasidone ([3aR,4S,7R,7aS]-2-[(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1yl-methyl] cyclohexylmethyl]-hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride; Latuda® [LRSD]) is a novel benzisothiazole, second-generation antipsychotic drug developed by Dainippon Sumitomo Pharma Corporation in Japan. Similar to other atypical antipsychotics it has a distinctive pharmacodynamic profile, Areas covered: This review updates reported research findings on the efficacy, safety and tolerability of LRSD for treatment of psychotic and major affective disorders, with meta-analyses...
September 13, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28854830/corrigendum
#16
(no author information available yet)
No abstract text is available yet for this article.
August 30, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28817316/filling-quality-of-the-reports-of-adverse-drug-reactions-received-at-the-pharmacovigilance-centre-of-s%C3%A3-o-paulo-brazil-missing-information-hinders-the-analysis-of-suspected-associations
#17
Adalton Ribeiro, Silvana Lima, Maria-Elisa Zampieri, Mirtes Peinado, Albert Figueras
Background The completeness and accuracy of the reports of suspected adverse drug reactions is important in pharmacovigilance. The aim of the present study was to analyze the quality of the information included in the reports sent to the Pharmacovigilance Centre of São Paulo (Brazil). Research Design and Methods A sample of 999 reports received from January 2013 to December 2014 was selected. The quality of the filled information was evaluated according to a 'sufficiency' criterion to apply the Karch-Lasagna causality algorithm...
August 17, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28889761/safety-issues-associated-with-using-medication-to-treat-overactive-bladder
#18
George Araklitis, Linda Cardozo
The mainstay of overactive bladder treatment is the use of anticholinergic medication with its common side effects well known. This review focused on three less well-known safety issues when treating OAB. Areas covered: Patients with increased anticholinergic load are at risk of cognitive decline, dementia or even death. The elderly are particularly at risk due to polypharmacy. Botulinum toxin carries the risk of high urinary residuals, urinary tract infection and need to self catheterise. The use of vaginal oestrogens may improve OAB symptoms, but there is concern in those with a history of breast cancer...
November 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28879784/non-chemotherapy-drug-induced-neutropenia-an-update
#19
Emmanuel Andrès, Rachel Mourot-Cottet
To date, non-chemotherapy drug-induced severe neutropenia (neutrophil count of ≤0.5 x 10(9)/L) also called idiosyncratic drug-induced agranulocytosis is little discussed in the literature. In the present paper, we report and discuss the clinical data and management of this rare disorder. Areas covered: To do this, we carried out a review of the literature using PubMed database of the US National Library of Medicine. We also used data from the American Society of Hematology educational books, textbooks of Hematology and Internal medicine, and information gleaned from international meetings...
November 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28871813/unspecified-intestinal-malabsorption-in-patients-treated-with-angiotensin-converting-enzyme-inhibitors-or-angiotensin-receptor-blockers-a-retrospective-analysis-in-primary-care-settings
#20
Nicola De Bortoli, Claudio Ripellino, Nazarena Cataldo, Santino Marchi
OBJECTIVE: To investigate the possible relationship between the use of Angiotensin II Receptor Blockers (ARBs) or Angiotensin-Converting-Enzyme Inhibitors (ACE-i) and unspecified intestinal malabsorption (IM) within the Italian and German real-life context. RESEARCH DESIGN AND METHODS: a retrospective cohort of patients with a new unspecified IM diagnosis during the period 1 January 2010-31 December 2013 was extracted from Italian IMS Health Longitudinal Patient Database and German IMS Disease Analyzer...
November 2017: Expert Opinion on Drug Safety
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