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Expert Opinion on Drug Safety

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https://www.readbyqxmd.com/read/28730840/the-safety-of-available-and-emerging-options-for-emergency-contraception
#1
Jessica K Lee, Eleanor Bimla Schwarz
Emergency contraception (EC) is a way to significantly reduce the chance of becoming pregnant after an episode of unprotected intercourse. Considerable data support the safety of all available and emerging options for EC. Areas covered: This review presents a comprehensive summary of the literature regarding the safety of EC as well as directions for further study. PubMed was searched for all relevant studies published prior to June 2017. Expert Opinion: All available methods of EC (i.e., ulipristal acetate pills, levonorgestrel pills, and the copper-IUD), carry only mild side effects and serious adverse events are essentially unknown...
July 21, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28724335/exploring-the-potential-for-using-drug-indications-to-prevent-look-alike-and-sound-alike-drug-errors
#2
Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio, Saad Alqahtani, Gordon Schiff
BACKGROUND: Look-alike, sound-alike (LASA) drug names are a cause of medication errors with resulting patient harm and healthcare costs. This study assessed to which extent the use of the generic drug name, therapeutic class, health problem, and the U.S. Food and Drug Administration (FDA)-approved indications might be used to differentiate LASA drug pairs. RESEARCH DESIGN AND METHODS: We collected information about LASA drug pairs reported by the FDA to have look-alike sound-alike similarities...
July 20, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28699790/safety-of-available-and-emerging-drug-therapies-for-hyperhidrosis
#3
Christine Hosp, Henning Hamm
Hyperhidrosis affects 4.8% of the U.S. population and has been underestimated by physicians for long time despite considerable interference with quality of life. Many patients suffer from primary (idiopathic) hyperhidrosis which results from over-activity of sympathetic nerves and is restricted to specific body areas, mostly the axillae, palms, soles, or head. Secondary hyperhidrosis is caused by an underlying disease or the intake of medications and often involves large parts of the body. Numerous effective therapies with topical or systemic drugs and surgical options are available...
July 16, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28705090/the-safety-of-available-treatments-options-for-neuroendocrine-tumors
#4
A Faggiano, F Lo Calzo, G Pizza, R Modica, A Colao
Neuroendocrine neoplasms (NEN) represent a heterogeneous group of malignancies generally characterized by low proliferation and indolent course. However, about half of the newly diagnosed cases are metastatic and require long-term systemic therapies. Areas covered: this review revise the literature to summarize the current knowledge upon safety of all systemic treatment options available. A total amount of 33 different clinical studies have been considered, including 4 on somatostatin analogues (SSA), 5 on targeted therapies, 10 on peptide receptor radionuclide therapy (PRRT), and 14 on chemotherapy...
July 14, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28699784/cancer-drugs-and-qt-prolongation-weighing-risk-against-benefit
#5
Pierantonio Menna, Emanuela Salvatorelli, G Minotti
No abstract text is available yet for this article.
July 12, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28661711/safety-of-ixazomib-for-the-treatment-of-multiple-myeloma
#6
Antoine Bonnet, Philippe Moreau
Despite a major positive impact of proteasome inhibitors (PI), such as bortezomib and carfilzomib, on the survival of patients with multiple myeloma (MM) over the last few years, their use in clinical practice is limited by the development of drug resistance, significant side-effects or constraining administration schedules. Ixazomib is the first, and for now the only, oral PI, which was approved by the US Food and Drug Administration in 2015 and by the European Medicines Agency in 2016. Areas covered: In this review, we provide an overview of the preclinical and early-phase studies of ixazomib used as single-agent and in combination...
July 12, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28697315/an-update-on-anesthetics-and-impact-on-the-brain
#7
Vincenzo Fodale, Vincenzo F Tripodi, Olivia Penna, Fausto Famà, Francesco Squadrito, Epifanio Mondello, Antonio David
While anesthetics are indispensable clinical tools and generally considered safe and effective, a growing concern over the potential neurotoxicity of anesthesia or specific anesthetic agents has called into question the safety of general anesthetics, especially when administered at extremes of age. Areas covered: This article reviews and updates research findings on the safety of anesthesia and anesthetics in terms of long-term neurotoxicity, with particular focus on postoperative cognitive dysfunctions, Alzheimer's disease and dementias, developing brain, post-operative depression and autism spectrum disorder...
July 11, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28697311/breast-cancer-treatment-induced-cardiotoxicity
#8
Samuel Martel, Christian Maurer, Matteo Lambertini, Noam Pondé, Evandro de Azambuja
Breast cancer is the most frequent cancer affecting women worlwide. In every setting, the majority of women are treated with an evergrowing arsenal of therapeutic agents that have greatly improved their outcomes. However, these therapies can also be associated with significant adverse events. Areas covered: This review aims to thoroughly describe the current state of the evidence regarding the potential cardiotoxicity of agents commonly used in the treatment of breast cancer. These include chemotherapeutic agents, anti-HER2 therapies and CDK4/6 and mTOR inhibitors...
July 11, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28679287/the-safety-of-nivolumab-for-the-treatment-of-metastatic-melanoma
#9
James Larkin, Aine O'Reilly
Nivolumab, a human IgG4 monoclonal antibody directed against PD-1, is a checkpoint inhibitor that is licenced in the treatment of metastatic melanoma either as a monotherapy or in combination with ipilimumab, a CTLA-4 inhibitor. The introduction of immune checkpoint inhibitors to the therapeutic landscape has dramatically altered outcomes in a proportion of patients with metastatic melanoma. Immune checkpoint inhibitors result in a toxicity profile that is distinct from that of chemotherapy or targeted therapy based on their immunomodulatory mechanism and similarly can result in patterns of response that are unique...
July 6, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28641031/treatment-options-for-nonalcoholic-steatohepatitis-a-safety-evaluation
#10
Danny Issa, Julia Wattacheril, Arun J Sanyal
There is an urgent as yet unmet need to develop highly effective and safe therapeutics for nonalcoholic fatty liver disease (NAFLD). The remarkable progress in understanding NAFLD pathogenesis allowed the identification of injury pathways which may be recruited as therapy targets. Areas covered: This article reviews the safety and tolerability data of the NAFLD therapies and explains the mechanistic basis for each of the established and investigational drugs. Treatment targets include: weight loss, anti-metabolic agents such as lipid lowering and anti-diabetic drugs, inflammation, fibrosis and others such as targeting gut microbiota, immune modulation and apoptosis...
July 6, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28678553/non-vitamin-k-antagonist-oral-anticoagulants-impact-of-non-adherence-and-discontinuation
#11
José Miguel Rivera-Caravaca, María Asunción Esteve-Pastor, Vanessa Roldán, Francisco Marín, Gregory Y H Lip
Non-Vitamin K Oral Anticoagulants (NOACs) are at least as effective as vitamin K antagonists (VKAs) reducing thromboembolism and mortality in atrial fibrillation (AF). These "fixed-dose regimen" drugs are characterized by not requiring routine monitoring or dosage adjustment. Stroke prevention with OAC is indicated in AF patients with CHA2DS2-VASc ≥2 (≥3 in females) and NOACs are recommended in preference to VKAs. However, underuse, premature discontinuation of treatment and non-adherence to guidelines is common, and independently associated with higher stroke risk and all-cause mortality...
July 5, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28678552/acetylcholinesterase-inhibitors-for-treating-dementia-symptoms-a-safety-evaluation
#12
Dana Mohammad, Parco Chan, Janelle Bradley, Krista Lanctôt, Nathan Herrmann
The prevalence of Alzheimer's disease (AD) continues to rise, while treatment options for cognitive impairment are limited. Acetylcholinesterase inhibitors (AChEIs) aim to provide symptomatic benefit for cognitive decline, however these drugs are not without adverse events (AEs). The safety profile of each drug must be taken carefully into consideration before being prescribed, as new dosages and formulations have recently been approved. Areas Covered: Donepezil, galantamine and rivastigmine are the three AChEIs approved for the treatment of varying stages of AD...
July 5, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28678550/the-safety-of-albiglutide-for-the-treatment-of-type-2-diabetes
#13
Marc S Rendell
Albiglutide is a marketed long acting GLP-1 receptor agonist (GLP-1 RA) administered by weekly injection. It has significantly less gastrointestinal side effects than other GLP-1 RAs in current use but does not improve HbA1c or promote weight loss to the same extent as competitor agents such as liraglutide. Area Covered: The safety of albiglutide is discussed. The review encompassed a search of PubMed and a thorough analysis of the European Union and US Food and Drug Administration approval documents. Expert Opinion: Unlike competitor agents, the gastrointestinal side effects of albiglutide are not much greater than placebo...
July 5, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28641055/long-term-safety-evaluation-of-natalizumab-for-the-treatment-of-multiple-sclerosis
#14
Marinella Clerico, Carlo Alberto Artusi, Alessandra Di Liberto, Simona Rolla, Valentina Bardina, Pierangelo Barbero, Stefania Federica De Mercanti, Luca Durelli
Natalizumab is a humanized monoclonal antibody highly effective in relapsing-remitting multiple sclerosis (MS). Important concerns about its safety have been pointed out mainly because of the risk of progressive multifocal leukoencephalopathy (PML), caused by the opportunistic John-Cunningham virus (JCV). Areas covered: This review analyzes all the safety aspects related to the use and safety of natalizumab in MS patients. Other than PML, post-marketing, safety red-flags have been reported, as liver or haematological serious adverse events...
July 5, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28664754/safety-and-benefit-considerations-for-menopausal-hormone-therapy
#15
James H Pickar, David F Archer, Risa Kagan, JoAnn V Pinkerton, Hugh S Taylor
While benefits and risks of hormone therapy (HT) have been shown in rigorous randomized, controlled trials, clinical use and further study have discovered effects of age, time of HT initiation, and differential effects of various regimens and administration routes on its safety profile. Areas covered: The safety of HT with regard to cardiovascular disease, thrombosis, the endometrium, the breast, and cognition was reviewed. Differential safety effects of estradiol versus conjugated equine estrogens, and progesterone versus synthetic progestins are reported...
June 30, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28657366/psychiatric-disorders-acne-and-systemic-retinoids-comparison-of-risks
#16
M Le Moigne, S Bulteau, Marie Grall-Bronnec, M Gerardin, Jean-Pascal Fournier, A P Jonville-Bera, Pascale Jolliet, Brigitte Dreno, C Victorri-Vigneau
BACKGROUND: The link between isotretinoin, treatment of a severe form of acne, and psychiatric disorders remains controversial, as acne itself could explain the occurrence of psychiatric disorders. This study aims at assessing the disproportionality of psychiatric adverse events reported with isotretinoin in the French National PharmacoVigilance Database, compared with other systemic acne treatments and systemic retinoids. MATERIALS AND METHODS: Data were extracted from the French National PharmacoVigilance Database for systemic acne treatments, systemic retinoids and drugs used as comparators...
June 28, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28656780/brimonidine-and-brinzolamide-for-treating-glaucoma-and-ocular-hypertension-a-safety-evaluation
#17
Jed Asher Lusthaus, Ivan Goldberg
Brimonidine tartrate and brinzolamide eye drops are often used as third and fourth line treatment options to reduce intraocular pressure (IOP) in the management of glaucoma and ocular hypertension. Better tolerated, more effective topical agents requiring once daily instillation including prostaglandin analogues and beta-blockers usually are preferred as initial therapy, unless there are contraindications. Brimonidine and brinzolamide are often required owing to progressive glaucoma or intolerances to or ineffectiveness of front-line agents...
June 28, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28649864/the-french-addictovigilance-network-clinical-assessment-z-drugs-true-false-twins
#18
Morgane Rousselet, Fanny Feuillet, Marie Gerardin, Pascale Jolliet, Jean-Benoit Hardouin, Caroline Victorri-Vigneau
INTRODUCTION: In France, an addictovigilance network is responsible for evaluating drug dependence, by drawing on pharmacoepidemiological studies, clinical studies and by assessing healthcare professionals' reports on problematic consumption. METHODS: The aim of this study was to determine whether zolpidem and zopiclone have different dependence profiles, based on healthcare professionals' reports, and to identify various consumer dependence profiles among zolpidem users and among zopiclone users...
June 28, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28636836/antiviral-treatment-of-hepatitis-c-in-renal-transplant-patients-safety-issues
#19
Stella De Nicola, Massimo Colombo
No abstract text is available yet for this article.
June 21, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28627951/the-safety-of-bruton-s-tyrosine-kinase-inhibitors-for-the-treatment-of-chronic-lymphocytic-leukemia
#20
Phu N Tran, Susan O'Brien
The approval of ibrutinib has revolutionized the therapeutic landscape of chronic lymphocytic leukemia (CLL). Currently ibrutinib is indicated for patients that are both treatment naïve as well as those with relapsed CLL. Ibrutinib is generally well-tolerated with durable responses that improve over time in most patients. Important toxicities include atrial fibrillation and bleeding. Areas Cover: This review covers the pharmacokinetics, pharmacodynamics, safety and efficacy of ibrutinib in the treatment of CLL...
June 19, 2017: Expert Opinion on Drug Safety
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