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Nocebo effects: more investigation is needed.
Authors: Benedetti F, Shaibani A PMID: 29768057 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 19, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Corrigendum.
Authors: PMID: 29768100 [PubMed - in process] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 19, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Expression of concern.
Authors: PMID: 29768101 [PubMed - in process] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 19, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety profile of medications used to treat Waldenstr öm's macroglobulinemia.
A safety profile of medications used to treat Waldenström's macroglobulinemia. Expert Opin Drug Saf. 2018 May 17;: Authors: García-Sanz R, Jiménez C, González de la Calle V, Sarasquete ME Abstract INTRODUCTION: 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...
Source: Expert Opinion on Drug Safety - May 19, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A comparison of approaches to identify possible cases of local anesthetic systemic toxicity in the FDA Adverse Event Reporting System (FAERS) database.
CONCLUSIONS: Our findings suggest the estimated incidence of possible LAST cases with LB is similar to, or less than, the reported incidence with other injectable local anesthetics. PMID: 29745266 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 12, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of trifluridine and tipiracil for the treatment of metastatic colorectal cancer.
Authors: Martinez-Perez J, Riesco-Martinez MC, Garcia-Carbonero R Abstract INTRODUCTION: TAS102 is an oral thymidine-based nucleoside analogue that has been approved for the treatment of patients with metastatic colorectal cancer (mCRC) previously treated with, or not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vascular endothelial growth factor (VEGF) agents and, if RAS wild-type, anti-epidermal growth factor receptor (EGFR) therapy. The pivotal RECOURSE phase III trial demonstrated a significant improvement in disease control rate, progre...
Source: Expert Opinion on Drug Safety - May 12, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of indacaterol for the treatment of COPD.
Authors: Metaxas EI, Balis E Abstract INTRODUCTION: Bronchodilators, namely long-acting inhaled β2-agonists and long-acting muscarinic antagonists, are the first-line medications for chronic obstructive pulmonary disease (COPD). The safety of these medicines is of great concern since COPD patients usually have other co-morbidities such as cardio- and cerebrovascular diseases. Areas covered: In this review we present information about the safety and the use of indacaterol in COPD. Indacaterol is the first once-daily, long-acting inhaled β2-agonist approved for COPD. We provide data about its mechanism of a...
Source: Expert Opinion on Drug Safety - May 10, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of dual bronchodilation on cardiovascular serious adverse events in COPD.
Authors: Rogliani P, Ora J, Matera MG, Cazzola M, Calzetta L Abstract Introduction Long-acting β2-adrenoceptor (β2-AR) agonists (LABAs) plus long-acting muscarinic antagonists (LAMAs) is the cornerstone for treating chronic obstructive pulmonary disease (COPD). LABA/LAMA combinations elicit clinical and functional synergistic interaction, and such an interaction should permit to reduce the dose of each monocomponent in the drug mixture to minimize the risk of adverse events (AEs). Overall, currently available LABA/LAMA fixed-dose combinations (FDCs) combine the drugs at the same doses of formulations desi...
Source: Expert Opinion on Drug Safety - May 3, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Letter to editor: Androgenetic alopecia; drug safety and therapeutic strategies.
Authors: Ong G, Manyak M, Lulic Z PMID: 29707969 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 2, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Response to the Letter to the Editor.
Authors: Motofei IG PMID: 29707983 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 2, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The Tolerability and Safety Profile of Patiromer: A Novel Polymer-Based Potassium Binder for the Treatment of Hyperkalemia.
Authors: Pitt B, Garza D Abstract INTRODUCTION: Hyperkalemia (HK) occurs often among patients with chronic kidney disease (CKD) and heart failure (HF) and those treated with renin-angiotensin-aldosterone system inhibitors (RAASI). Even small deviations from normal potassium levels carry increased risk of mortality. Patiromer is approved for treatment of HK and has been shown in clinical trials to reduce serum potassium among patients with HK and comorbid conditions. Areas covered: We review pooled data from two clinical trials of patiromer in patients with CKD and HK, safety of patiromer in special populations, dru...
Source: Expert Opinion on Drug Safety - April 19, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

An update on adverse drug reactions related to β-lactam antibiotics.
An update on adverse drug reactions related to β-lactam antibiotics. Expert Opin Drug Saf. 2018 Apr 10;: Authors: Vardakas KZ, Kalimeris GD, Triarides NA, Falagas ME Abstract INTRODUCTION: β-lactams have been consistently associated with the majority of drug-related adverse events. Generally, these are mild under proper dosing and judicious selection. Areas covered: Immediate hypersensitivity reactions are the most feared adverse events encountered after β-lactam administration. Emerging evidence shows that immediate reactions are not as common as previously thought. Specialist consultat...
Source: Expert Opinion on Drug Safety - April 12, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Evaluation of dystonia in children and adolescents treated with atomoxetine within the Truven MarketScan database: a retrospective cohort study.
CONCLUSION: In this large retrospective cohort study, there was no significant difference in incidence or risk of dystonia among patients treated with atomoxetine compared to stimulants. PMID: 29625537 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 9, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Does high-dose benzodiazepine abuse really produce liver toxicity? Results from a series of 201 benzodiazepine monoabusers.
CONCLUSIONS: Present data suggest that prolonged use of high-dose BZD, although very dangerous for several reasons, does not seem to produce a significant drug-induced liver injury. PMID: 29621907 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 8, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Analyzing research trends on drug safety using topic modeling.
Authors: Zou C Abstract INTRODUCTION: Published drug safety data has evolved in the past decade due to scientific and technological advances in the relevant research fields. Considering that a vast amount of scientific literature has been published in this area, it is not easy to identify the key information. Topic modeling has emerged as a powerful tool to extract meaningful information from a large volume of unstructured texts. Areas covered: We analyzed the titles and abstracts of 4347 articles in four journals dedicated to drug safety from 2007 to 2016. We applied Latent Dirichlet allocation (LDA) model to extr...
Source: Expert Opinion on Drug Safety - April 8, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Preventable statin adverse reactions and therapy discontinuation. What can we learn from the spontaneous reporting system?
CONCLUSIONS: Our findings suggest an inappropriate use of statins among the identified preventable cases and a potential inappropriate statin discontinuation due to ADRs. These factors may be useful for targeting interventions to improve statin adherence. PMID: 29619841 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 6, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A randomized, open-label, comparative, two-period crossover trial on preference, efficacy, and safety profiles of a prefilled, disposable pen with lispro insulin u-100 versus concentrated lispro insulin u-200 in patients with type 2 diabetes mellitus: a possible contribution to increase adherence.
CONCLUSIONS: The use of U-200 lispro might improve treatment adherence and metabolic control. PMID: 29564932 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 23, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Cardiovascular effects of antimuscarinic agents and beta3-adrenergic receptor agonist for the treatment of overactive bladder.
Authors: Rosa GM, Baccino D, Valbusa A, Scala C, Barra F, Brunelli C, Ferrero S Abstract INTRODUCTION: Overactive bladder (OAB) syndrome is common in the general population, particularly in elderly patients. Antimuscarinic drugs (AMs) are considered the mainstay pharmaceutical treatment of OAB whereas β3-adrenoceptor agonists, such as mirabegron, represent a good alternative. Owing to the important role of muscarinic and β3 receptors in cardiovascular (CV) tissue and to the fact that OAB patients often have CV comorbidities, the safety-profile of these drugs constitute an important challenge. Area covered...
Source: Expert Opinion on Drug Safety - March 20, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Clinical safety and tolerability of tedizolid phosphate in the treatment of acute bacterial skin and skin structure infections.
Authors: Hardalo C, Lodise TP, Bidell M, Flanagan S, De Anda C, Anuskiewicz S, Prokocimer P Abstract BACKGROUND: We evaluated safety and tolerability of tedizolid phosphate at the 200-mg once-daily dose approved for 6-day treatment of skin and skin-structure infections. RESEARCH DESIGN AND METHODS: Clinical adverse event (AE) and laboratory data were pooled across completed clinical studies (13 phase 1, two phase 2, and two phase 3), for all participants who received ≥1 dose of tedizolid 200 mg, linezolid 600 mg (phase 3 only), or placebo (phase 1 only). RESULTS: 1280 participants received tedi...
Source: Expert Opinion on Drug Safety - March 13, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Addendum.
Authors: PMID: 29514520 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 10, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety comparison of LABA+LAMA vs LABA+ICS combination therapy for COPD.
Authors: Matera MG, Calzetta L, Puxeddu E, Rogliani P, Cazzola M Abstract INTRODUCTION: LABA+LAMA and LABA+ICS combinations are key pharmacological approaches to the treatment of COPD. However, both combination types can induce adverse events (AEs). Areas covered: Current literature on LABA+LAMA and LABA+ICS combinations has been reviewed with a specific focus on their safety profile in the treatment of COPD. Expert opinion: Several meta-analyses have compared the pooled safety data from randomized clinical trials (RCTs) of LABA+LAMA combinations with LABA+ICS combinations. LABA+LAMA caused significantly less AEs a...
Source: Expert Opinion on Drug Safety - March 7, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety of treatment options for spondyloarthritis: a narrative review.
Authors: D'Angelo S, Carriero A, Gilio M, Ursini F, Leccese P, Palazzi C Abstract INTRODUCTION: Spondyloarthritis (SpA) are chronic inflammatory diseases with overlapping pathogenic mechanisms and clinical features. Treatment armamentarium against SpA includes non-steroidal anti-inflammatory drugs, glucocorticoids, conventional disease-modifying antirheumatic drugs (DMARDs, including sulfasalazine, methotrexate, leflunomide, cyclosporine), targeted synthetic DMARDs (apremilast) and biological DMARDs (TNF inhibitors, anti-IL 12/23 and anti-IL-17 agents). Areas covered: A narrative review of published literature on s...
Source: Expert Opinion on Drug Safety - March 7, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety of humanized monoclonal antibodies against IL-5 in asthma: focus on reslizumab.
Authors: Cazzola M, Matera MG, Levi-Schaffer F, Rogliani P 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 exacerbations despite receiving their current asthma medicines. Areas covered: Current literature on reslizumab has been reviewed with a specific focus on its safety profile in the treatment of severe asthma. Expert opinion: Large pivo...
Source: Expert Opinion on Drug Safety - March 2, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety evaluation of budesonide MMX for the treatment of ulcerative colitis.
Authors: Bezzio C, Festa S, Zerboni G, Papi C, Manes G, Saibeni S Abstract INTRODUCTION: Budesonide belongs to low-bioavailability steroids class. A novel oral formulation of budesonide, which uses the Multi-Matrix System (MMX) for delivering drugs to the colon, is now available as a possible treatment of ulcerative colitis patients intolerant or not-responding to first-line therapy with 5-ASA. Areas covered: in this review we present information about the development and the use of budesonide MMX and we provide data about its mechanism of action as well as, pharmacodynamics and pharmacokynetics. Moreover, we prese...
Source: Expert Opinion on Drug Safety - February 25, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of gliptins : updated data in 2018.
Authors: Scheen AJ Abstract INTRODUCTION: Dipeptidyl peptidase-4 inhibitors (DPP-4is) are generally considered as glucose-lowering agents with a safe profile in type 2 diabetes. Areas covered: An updated review of recent safety data from randomised controlled trials, observational studies, meta-analyses, pharmacovigilance reports regarding alogliptin, linagliptin, saxagliptin, sitagliptin, and vildagliptin, with a special focus on risks of hypoglycaemia, pancreatitis and pancreatic cancer, major cardiovascular events, hospitalisation for heart failure and other new safety issues, such as bone fractures and arthralg...
Source: Expert Opinion on Drug Safety - February 24, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Suspected adverse drug reaction reports with oral anticoagulants in Portugal: a pharmacovigilance study.
CONCLUSIONS: Reporting of ADRs associated with oral anticoagulants (mainly NOACs), is increasing. Exploratory disproportion analyses showed an increase of reports of nervous system ADRs with NOACs, and INR-related ADRs with VKA. PMID: 29463153 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - February 22, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The nature, magnitude, and reporting compliance of device-related events for intravenous patient-controlled analgesia in the FDA Manufacturer and User Facility Device Experience (MAUDE) database.
CONCLUSION: Patients on IV-PCA continue to experience serious complications as a result of preventable errors. Multi-modal interventions including educational training and the development and adoption of PCA devices with improved safety features are needed to improve safety. PMID: 29463158 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - February 22, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Improving multiple sclerosis management and collecting safety information in the real world: the MSDS3D software approach.
Authors: Haase R, Wunderlich M, Dillenseger A, Kern R, Akgün K, Ziemssen T Abstract INTRODUCTION: For safety evaluation, randomized controlled trials (RCTs) are not fully able to identify rare adverse events. The richest source of safety data lies in the post-marketing phase. Real-world evidence (RWE) and observational studies are becoming increasingly popular because they reflect usefulness of drugs in real life and have the ability to discover uncommon or rare adverse drug reactions. Areas covered: Adding the documentation of psychological symptoms and other medical disciplines, the necessity for a complex d...
Source: Expert Opinion on Drug Safety - February 15, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The launch of opicapone for Parkinson's disease: negatives versus positives.
Authors: Castro Caldas A, Teodoro T, Ferreira JJ Abstract INTRODUCTION: Opicapone is a novel, third generation COMT inhibitor approved for the treatment of Parkinson's disease. Safety and tolerability data is critical to determine the benefit-harm balance and anticipate therapeutic adherence. Areas covered: This review evaluates the tolerability and safety profile of opicapone. These data were extracted from all published clinical trials, including preclinical, phase I, phase II and phase III studies as well as postmarketing data. Opicapone was safe and well tolerated, with frequencies of treatment-emergent adverse...
Source: Expert Opinion on Drug Safety - February 10, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of pharmacologic treatment for pediatric obesity.
Authors: Chao AM, Wadden TA, Berkowitz RI Abstract INTRODUCTION: Pediatric obesity is a serious public health concern. Five medications have been approved by the Food and Drug Administration (FDA) for chronic weight management in adults with obesity, when used as an adjunct to lifestyle modification. Orlistat is the only FDA-approved medication for pediatric patients aged 12 years and above. Areas covered: This paper summarizes safety and efficacy data from clinical trials of weight loss medications conducted among pediatric samples. Relevant studies were identified through searches in PubMed. Expert opinion: ...
Source: Expert Opinion on Drug Safety - February 8, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Androgenetic alopecia; drug safety and therapeutic strategies.
Authors: Motofei IG, Rowland DL, Baconi DL, Tampa M, Sârbu MI, Păunică S, Constantin VD, Bălălău C, Păunică I, Georgescu SR Abstract INTRODUCTION: Androgenetic alopecia (AGA) is a benign condition with variable psychosocial impact, with some individuals adapting well while others needing therapeutic support. Although 5α-reductase inhibitors like finasteride and dutasteride have proven effective in ameliorating AGA, their use/selection is currently a subject of debate. Areas covered: Treatment of AGA with 5α-reductase inhibitors lead to variable adverse effects and relatively unstable result...
Source: Expert Opinion on Drug Safety - January 26, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Anticoagulant and antiplatelet therapy choices for patients with atrial fibrillation one year after coronary stenting or acute coronary syndrome.
Authors: Olivier CB, Turakhia MP, Mahaffey KW Abstract INTRODUCTION: Guidelines recommend a combined anticoagulant and antiplatelet approach for patients with atrial fibrillation (AF) after coronary stenting (CS) or acute coronary syndrome (ACS). Finding the optimal balance of reducing ischemic risk and minimizing bleeding risk is challenging. Recent trials have evaluated a variety of regimens for up to one year for AF patients after CS/ACS. Little empiric evidence exists about the best antithrombotic strategy beyond one year. Areas covered: In this review two key areas are covered. First, a summary of the overall ...
Source: Expert Opinion on Drug Safety - January 26, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Risks and benefits of medications for panic disorder: a comparison of SSRIs and benzodiazepines.
Authors: Quagliato LA, Freire RC, Nardi AE Abstract INTRODUCTION: Panic disorder (PD) is a prevalent and disabling anxiety disorder that can be treated effectively. Selective serotonin reuptake inhibitors (SSRIs) and benzodiazepines are among the most frequently prescribed drugs for PD. In this article, the authors review the current evidence on efficacy, adverse events, and limitations of these two treatment options. Areas covered: MEDLINE/Pubmed and Web of Science databases were searched for open or placebo-controlled trials on SSRIs and/or benzodiazepines in PD treatment. Expert opinion: The literature search yi...
Source: Expert Opinion on Drug Safety - January 25, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety and efficacy of denosumab in osteoporotic patients previously treated with other medications: a systematic review and meta-analysis.
Authors: Fontalis A, Eustathios K, Prousali E, Michael P, Eleftherios T Abstract INTRODUCTION: Denosumab is a monoclonal antibody that received approval by the FDA for the treatment of osteoporosis in 2010. Available higher level research evidence concerns the treatment of patients that have not received any anti-osteoporotic medication in the past. Further investigation is warranted, since clinicians often face the challenge of administering the most efficacious drug in patients, pretreated with other medications. Areas Covered: We conducted a systematic review and meta-analysis to evaluate the efficacy and safety...
Source: Expert Opinion on Drug Safety - January 21, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of palbociclib for the treatment of advanced breast cancer.
Authors: Degenhardt T, Wuerstlein R, Eggersmann T, Harbeck N Abstract INTRODUCTION: Despite improvements in the diagnosis and management of early stage breast cancer, about one third of the patients still progress to metastatic disease. Most of the patients with metastatic breast cancer have a hormone receptor positive and human epidermal growth factor receptor 2 negative subtype with a median survival of more than 3 years. For these patients, endocrine therapy with its favorable toxicity profile is the current standard of care. However, patients with metastatic breast cancer have an incurable disease. Therefore, n...
Source: Expert Opinion on Drug Safety - January 19, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

An update on the safety of nutraceuticals and effects on lipid parameters.
Authors: Cicero AFG, Colletti A Abstract INTRODUCTION: Cardiovascular diseases (CVDs) are the leading cause of mortality and disability in developed countries, whereas a large portion of patients in primary prevention have uncontrolled level of CVD risk factors. Dietary supplementation with bioactive natural compounds with demonstrated lipid-lowering effects is currently supported by the international guidelines for CVD prevention and some international expert panels. Areas covered: This review provides insights on issues concerning the tolerability and safety of the most commonly used nutraceuticals with demonstra...
Source: Expert Opinion on Drug Safety - January 19, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of available treatments of male hypogonadism in organic and functional hypogonadism.
Authors: Corona G, Rastrelli G, Reisman Y, Sforza A, Maggi M Abstract INTRODUCTION: In the case of primary male hypogonadism (HG), only testosterone (T) replacement therapy (TRT) is possible whereas when the problem is secondary to a pituitary or hypothalamus alteration both T production and fertility can be, theoretically, restored. We here systematically reviewed and discussed the advantages and limits of medications formally approved for the treatment of HG. Areas covered: Data derived from available meta-analyses of placebo controlled randomized trials (RCTs) were considered and analyzed. Gonadotropins are well...
Source: Expert Opinion on Drug Safety - January 16, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A Comparative Safety Review between GLP-1 Receptor Agonists and SGLT2 Inhibitors for Diabetes Treatment.
Authors: Consoli A, Formoso G, Baldassarre MPA, Febo F Abstract INTRODUCTION: Glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium glucose cotransporter 2 inhibitors (SGLT2i) are of particular interest in type 2 diabetes treatment strategies, due to their efficacy in reducing HbA1c with a low risk of hypoglycaemia, to their positive effects on body weight and blood pressure and in light of their effects on cardiovascular risk and on nephroprotection emerged from the most recent cardiovascular outcome trials. Since it is therefore very likely that GLP-1RA and SGLT2i use will become more and more common, it...
Source: Expert Opinion on Drug Safety - January 16, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The cardiovascular effect of incretin-based therapies among type 2 diabetes: a systematic review and network meta-analysis.
CONCLUSIONS: Incretin-based therapies show similar cardiovascular risk in comparison with metformin, insulin, thiazolidinediones, alpha-glucosidase inhibitor and sodium-glucose co-transporter 2. GLP-1RA could decrease the risk compared with sulfonylurea or placebo, while DPP-4I appears to have neutral effect on cardiovascular risk. PMID: 29320889 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - January 13, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Twelve weeks of ombitasvir/paritaprevir/r and dasabuvir without ribavirin is effective and safe in the treatment of patients with HCV genotype 1b infection and compensated cirrhosis: results from a real-world cohort study.
CONCLUSIONS: The simplified regimen of OBV/PTV/r+DSV administered for 12 weeks is effective and safe in patients with chronic HCV genotype 1b infection and compensated cirrhosis. No adverse reactions related to drug-drug interactions were recorded. PMID: 29325476 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - January 13, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The role of Iloprost on bone oedema and osteonecrosis: Review of current evidence.
Authors: Pountos I, Giannoudis PV Abstract INTRODUCTION: Iloprost is a commercially available prostaglandin I2 (PGI2) analogue that is shown to have antithrombotic, vasodilatative and antiproliferative effects. A number of clinical studies have shown that Iloprost can be effective in the management of bone marrow oedema and the treatment of avascular necrosis. The aim of this manuscript is to present our current understanding on the effect of Iloprost on the treatment of these conditions. Areas covered: The authors offer a comprehensive review of the existing literature on the experimental and clinical studies anal...
Source: Expert Opinion on Drug Safety - January 11, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Effects of interdisciplinary collaboration in hospitals on medication errors: an integrative review.
Authors: Manias E Abstract INTRODUCTION: Medication errors are commonly affected by breakdowns in communication. Interdisciplinary collaboration is an important means of facilitating communication between health professionals in clinical practice. To date, there has been little systematic examination of past research in this area. Areas covered: The aims of this integrative review are to examine how interdisciplinary collaboration influences medication errors in hospitals, the araes of interdisciplinary collaboration that have been researched in previous work, and recommendations for future research and practice. A...
Source: Expert Opinion on Drug Safety - January 6, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Preventable ADRs leading to hospitalization - results of a long-term prospective safety study with 6,427 ADR cases focusing on elderly patients.
CONCLUSION: Avoiding PIM usage seems to be of limited value in increasing safety in elderly patients whereas our results underline the importance of an individualized medication review of the most commonly implicated drugs in preventable ADRs (supported by BfArM FoNr: V-11337/68605/2008-2010). PMID: 29258401 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - December 22, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

New and Incremental FDA Black Box Warnings from 2008 to 2015.
CONCLUSIONS: New BBWs and incremental updates to existing BBWs are frequently added to drug labels after regulatory approval. PMID: 29215916 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - December 9, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Therapeutic drug monitoring of anti-TNF therapy in children with inflammatory bowel disease.
Authors: van Hoeve K, Hoffman I, Vermeire S Abstract INTRODUCTION: Although anti-TNF therapy has changed the scenery of pediatric inflammatory bowel diseases (IBD) immensely, there are still patients with an unfortunate outcome. Approximately one third of patients that initially respond to anti-TNF therapy will lose that response over time and need treatment optimization. Loss of response (LOR) is a big concern in IBD management and especially among pediatric patients where treatment options are more limited than in adults. In children it is even more important to sustain response with minimal toxicity. Therapeutic...
Source: Expert Opinion on Drug Safety - December 7, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety evaluation of raltegravir for the treatment of HIV.
Authors: de Miguel R, Montejano R, Stella-Ascariz N, Arribas JR Abstract INTRODUCTION: Raltegravir (RAL) was the first commercialized agent from a new drug class with an innovative target, the integrase. Since its introduction in clinical practice RAL has become widely used for the treatment of HIV-1 infected patients. A decade after its approval, this article reviews key evidence from RAL with a special interest on safety outcomes. Areas covered: Pharmacologic, safety and efficacy data of RAL from clinical trials and post-commercialization published reports are hereby summarized after a literature review including...
Source: Expert Opinion on Drug Safety - December 6, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety review of the medications used to treat atopic dermatitis.
Authors: Shukla S, Feldman SR, Strowd LC Abstract INTRODUCTION: Atopic dermatitis (AD) is a common disease in children and adults which causes severe physical discomfort and psychosocial distress. Recently novel therapies for AD have been FDA approved for use which creates the need to review the safety surrounding current FDA approved AD medications. Areas covered: Published clinical studies involving topical and oral FDA approved medications for AD are included in this review. Authors used PubMed research database to search for clinical trials involving AD patients. Expert opinion: AD is a common disease which cur...
Source: Expert Opinion on Drug Safety - December 4, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

First experiences with a tool to measure the level of clinical information present in adverse drug reaction reports.
CONCLUSION: This is the first tool to give insight in the level of relevant clinical information present in ADR reports. It can be used internationally to compare reports coming from different reporting methods and different types of reporters in pharmacovigilance. PMID: 29157026 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 23, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Things fall apart with hepatocellular carcinoma and direct-acting antivirals.
Authors: Kutala B, Valla D, Marcellin P PMID: 29137488 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 17, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety review of medications used for labour induction.
This article reviews the safety of currently used induction agents. Prostaglandins and oxytocin have proven to be effective in labour induction, and their profiles will be reviewed in this article. We discuss the data that supports combining some of the agents. We also cover the safety of medications used for labour induction in setting of a scarred uterus. Expert Opinion: There is continuous debate about the ideal induction agent: one that balances safety with efficacy. We recommend the practice that there is not one perfect agent for all, and that the clinical scenario and previous obstetric history should be considered ...
Source: Expert Opinion on Drug Safety - November 17, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research