journal
MENU ▼
Read by QxMD icon Read
search

Expert Opinion on Drug Safety

journal
https://www.readbyqxmd.com/read/29468916/the-safety-of-gliptins-updated-data-in-2018
#1
André J Scheen
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 arthralgia...
February 22, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29463158/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
#2
Oluwadolapo D Lawal, Maitreyee Mohanty, Harrison Elder, Margie Skeer, Nathalie Erpelding, Ryan Lanier, Nathaniel Katz
BACKGROUND: The aim of this study is to determine the characteristics, magnitude, and the quality of reporting of mandated events involving intravenous patient-controlled analgesia (IV-PCA) devices in the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database; a postmarket surveillance system. METHODS: We utilized a mixed-methods approach to systematically characterize structured data and text narratives associated with IV-PCA events submitted to MAUDE between 1 January 2011 and 12 September 2016...
February 20, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29463153/suspected-adverse-drug-reaction-reports-with-oral-anticoagulants-in-portugal-a-pharmacovigilance-study
#3
Daniel Caldeira, Raquel Rodrigues, Daisy Abreu, Ana Marta Anes, Mário M Rosa, Joaquim J Ferreira
OBJECTIVE: In this pharmacovigilance study, we aimed to determine the incidence of spontaneously reported suspected adverse drug reactions (ADRs) related to oral anticoagulants: non-vitamin K antagonist oral anticoagulants (NOACs; apixaban, dabigatran, edoxaban, rivaroxaban) and vitamin K antagonists (VKA) Research design and methods: In this retrospective observational study, we extracted all the individual case safety reports related to oral anticoagulants recorded in the Portuguese Pharmacovigilance Database (January 2010 to April 2015)...
February 20, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29436244/improving-multiple-sclerosis-management-and-collecting-safety-information-in-the-real-world-the-msds3d-software-approach
#4
Rocco Haase, Maria Wunderlich, Anja Dillenseger, Raimar Kern, Katja Akgün, Tjalf Ziemssen
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 documentation becomes apparent...
February 13, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29411652/the-safety-of-pharmacologic-treatment-for-pediatric-obesity
#5
Ariana M Chao, Thomas A Wadden, Robert I Berkowitz
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...
February 7, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29363352/anticoagulant-and-antiplatelet-therapy-choices-for-patients-with-atrial-fibrillation-one-year-after-coronary-stenting-or-acute-coronary-syndrome
#6
Christoph B Olivier, Mintu P Turakhia, Kenneth W Mahaffey
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...
January 24, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29363345/androgenetic-alopecia-drug-safety-and-therapeutic-strategies
#7
Ion G Motofei, David L Rowland, Daniela L Baconi, Mircea Tampa, Maria-Isabela Sârbu, Stana Păunică, Vlad D Constantin, Cristian Bălălău, Ioana Păunică, Simona Roxana Georgescu
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 results (therapeutic efficacy ending with treatment cessation), so the choice of optimal therapy is not straightforward...
January 24, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29357714/risks-and-benefits-of-medications-for-panic-disorder-a-comparison-of-ssris-and-benzodiazepines
#8
Laiana A Quagliato, Rafael C Freire, Antonio E Nardi
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...
January 22, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29350565/safety-and-efficacy-of-denosumab-in-osteoporotic-patients-previously-treated-with-other-medications-a-systematic-review-and-meta-analysis
#9
Andreas Fontalis, Kenanidis Eustathios, Efthymia Prousali, Potoupnis Michael, Tsiridis Eleftherios
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 of denosumab compared to other active anti-osteoporotic agents in patients formerly receiving other treatments...
January 19, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29338448/the-safety-of-palbociclib-for-the-treatment-of-advanced-breast-cancer
#10
Tom Degenhardt, Rachel Wuerstlein, Tanja Eggersmann, Nadia Harbeck
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...
January 17, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29338456/an-update-on-the-safety-of-nutraceuticals-and-effects-on-lipid-parameters
#11
Arrigo F G Cicero, Alessandro Colletti
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 demonstrated lipid-lowering effect in humans...
January 16, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29334278/a-comparative-safety-review-between-glp-1-receptor-agonists-and-sglt2-inhibitors-for-diabetes-treatment
#12
Agostino Consoli, Gloria Formoso, Maria Pompea Antonia Baldassarre, Fabrizio Febo
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 is more and more important to gather and discuss information about their safety profile...
January 15, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29334271/the-safety-of-available-treatments-of-male-hypogonadism-in-organic-and-functional-hypogonadism
#13
G Corona, G Rastrelli, Y Reisman, A Sforza, M Maggi
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...
January 15, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29325476/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
#14
Esther Chamorro-de-Vega, Alvaro Gimenez-Manzorro, Carmen-Guadalupe Rodriguez-Gonzalez, Vicente Escudero-Vilaplana, Ana De Lorenzo-Pinto, Irene Iglesias-Peinado, Ana Herranz-Alonso, Maria Sanjurjo Saez
OBJECTIVE: To explore the effectiveness and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir (OBV/PTV/r+DSV) for 12 weeks without ribavirin in adults with chronic HCV genotype 1b infection and compensated cirrhosis. METHODS: Observational study of a prospective cohort of adult patients with HCV genotype 1b infection and compensated cirrhosis who received 12 weeks of OBV/PTV/r and DSV without ribavirin. Effectiveness was assessed by recording the percentage of patients achieving sustained virological response at week 12 post-treatment (SVR12)...
January 11, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29320889/the-cardiovascular-effect-of-incretin-based-therapies-among-type-2-diabetes-a-systematic-review-and-network-meta-analysis
#15
Shanshan Wu, Andrea Cipriani, Zhirong Yang, Jun Yang, Ting Cai, Yang Xu, Xiaochi Quan, Yuan Zhang, Sanbao Chai, Feng Sun, Siyan Zhan
OBJECTIVE: To evaluate the comparative cardiovascular safety of incretin-based therapies in patients with type 2 diabetes mellitus (T2DM). METHODS: Medline, Embase, the Cochrane Library and www.clinicaltrials.gov were searched for randomized controlled trials (RCTs) with duration≥12 weeks. Network meta-analysis was performed, followed by subgroup analysis and meta-regression. The Grading of Recommendations Assessment, Development and Evaluation system was used to assess the quality of evidence...
January 10, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29315006/the-role-of-iloprost-on-bone-edema-and-osteonecrosis-safety-and-clinical-results
#16
REVIEW
Ippokratis Pountos, Peter V Giannoudis
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 analysing the effect of Iloprost on bone, bone marrow oedema and avascular necrosis...
March 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29303376/effects-of-interdisciplinary-collaboration-in-hospitals-on-medication-errors-an-integrative-review
#17
Elizabeth Manias
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...
January 5, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29202588/therapeutic-drug-monitoring-of-anti-tnf-therapy-in-children-with-inflammatory-bowel-disease
#18
Karen van Hoeve, Ilse Hoffman, Severine Vermeire
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...
December 10, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29215916/new-and-incremental-fda-black-box-warnings-from-2008-to-2015
#19
Michael T Solotke, Sanket S Dhruva, Nicholas S Downing, Nilay D Shah, Joseph S Ross
BACKGROUND: The boxed warning (also known as "black box warning [BBW]") is one of the strongest drug safety actions that the U.S. Food & Drug Administration (FDA) can implement, and often warns of serious risks. The objective of this study was to comprehensively characterize BBWs issued for drugs after FDA approval. METHODS: We identified all post-marketing BBWs from January 2008 through June 2015 listed on FDA's MedWatch and Drug Safety Communications websites...
December 7, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29195486/a-safety-review-of-the-medications-used-to-treat-atopic-dermatitis
#20
Shweta Shukla, Steven R Feldman, Lindsay C Strowd
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 currently has limited FDA approved medications...
December 1, 2017: Expert Opinion on Drug Safety
journal
journal
40352
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"