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Expert Opinion on Drug Safety

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https://www.readbyqxmd.com/read/29215916/new-and-incremental-fda-black-box-warnings-from-2008-to-2015
#1
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/29202588/therapeutic-drug-monitoring-of-anti-tnf-therapy-in-children-with-inflammatory-bowel-disease
#2
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 5, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29199485/a-safety-evaluation-of-raltegravir-for-the-treatment-of-hiv
#3
Rosa de Miguel, Rocio Montejano, Natalia Stella-Ascariz, Jose R Arribas
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 PubMed search, relating proceedings and abstracts from relevant international HIV conferences, assessment reports from European and United States regulatory agencies and treatment guidelines (World Health Organization, United States Department of Health and Human Services and European AIDS Clinical Society), up to October 2017...
December 2, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29195486/a-safety-review-of-the-medications-used-to-treat-atopic-dermatitis
#4
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
https://www.readbyqxmd.com/read/29157026/first-experiences-with-a-tool-to-measure-the-level-of-clinical-information-present-in-adverse-drug-reaction-reports
#5
Ingrid Oosterhuis, Leàn Rolfes, Corine Ekhart, Annemarie Muller-Hansma, Linda Härmark
BACKGROUND: To make a proper causality assessment of an adverse drug reaction (ADR) report, a certain level of clinical information is necessary. A tool was developed to measure the level of clinical information present in ADR reports. The aim of this study was to test the validity and reliability of the clinical documentation tool (ClinDoc) in an international setting. METHODS: The tool was developed by a panel of pharmacovigilance experts. It includes four domains: ADR, chronology of the ADR, suspected drug and patient characteristics...
November 20, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29141462/a-safety-review-of-medications-used-for-labour-induction
#6
Lili Sheibani, Deborah A Wing
Induction of labour is a commonly performed procedure around the world. There are various medications used for induction including those commonly used for cervical ripening (prostaglandins) and oxytocin. The ideal agent is one that decreases the time to achieving delivery without compromising maternal or neonatal safety. The 'optimal safe agent' remains undetermined. Areas covered: 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...
November 15, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29137488/things-fall-apart-with-hepatocellular-carcinoma-and-direct-acting-antivirals
#7
Blaise Kutala, Dominique Valla, Patrick Marcellin
No abstract text is available yet for this article.
November 14, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29120249/alcohol-addiction-the-safety-of-available-approved-treatment-options
#8
Mariangela Antonelli, Anna Ferrulli, Luisa Sestito, Gabriele A Vassallo, Claudia Tarli, Carolina Mosoni, Maria M Rando, Antonio Mirijello, Antonio Gasbarrini, Giovanni Addolorato
Alcohol Use Disorder (AUD) is a leading cause of mortality and morbidity worldwide. At present disulfiram, naltrexone and acamprosate are approved for the treatment of AUD in U.S. and Europe. Nalmefene is approved in Europe and sodium oxybate is approved in Italy and Austria only. Baclofen received a "temporary recommendation for use" in France. Areas covered. The safety of the medications mentioned above on liver, digestive system, kidney function, nervous system, pregnancy and lactation and their possible side effects are described and discussed...
November 9, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29108432/efficacy-and-safety-of-a-combination-of-her2-targeted-agents-as-first-line-treatment-for-metastatic-her2-positive-breast-cancer-a-network-meta-analysis
#9
Henry W C Leung, John-Hang Leung, Agnes L F Chan
BACKGROUND: Using network meta-analysis, we assessed the efficacy and safety of a combination regimen of HER2-targeted agents as first-line treatment for metastatic HER2-positive breast cancer. METHODS: We searched the Medline, Embase, and Cochrane Library electronic databases (through December 2016) for phase II/III randomized controlled trials that compared regimens of one or two HER2-targeted agents combined with trastuzumab or chemotherapy. A network meta-analysis including direct and indirect analyses was conducted in WinBUGS using fixed and random effects...
November 6, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29103332/the-safety-of-available-treatment-options-for-iron-deficiency-anemia
#10
Manuel Muñoz, Susana Gómez-Ramírez, Sunil Bhandari
Iron deficiency (ID), with or without anemia, is highly prevalent worldwide and has clinical consequences. The prevention and treatment of ID is a major public health goal. Accurate diagnosis, selection of the appropriate iron replacement therapy and addressing the underlying cause, remain as the main challenges in ID management. Areas covered. This review aims to provide a narrative review of current available evidence on iron supplementation options regularly used to treat ID, including oral and intravenous (IV) iron formulations, with emphasis on safety issues...
November 6, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29103328/skin-cancer-associated-with-commonly-prescribed-drugs-tumor-necrosis-factor-alpha-inhibitors-tnf-%C3%AE-is-angiotensin-receptor-blockers-arbs-phosphodiesterase-type-5-inhibitors-pde5is-and-statins-weighing-the-evidence
#11
Beatrice Nardone, Kelsey A Orrell, Paras P Vakharia, Dennis P West
Skin cancers, including both malignant melanoma (MM) and nonmelanoma skin cancer (NMSC), are the most commonly diagnosed cancers in the US. The incidence of both MM and NMSC continues to rise. Areas Covered: Current evidence for an association between four of the most commonly prescribed classes of drugs in the U.S. and risk for MM and NMSC is reported. Medline was searched (January 2000 to May 2017) for each drug in the classes and for "basal cell carcinoma", "squamous cell carcinoma", "non-melanoma skin cancer", "skin cancer" and "melanoma"...
November 6, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29076385/post-marketing-withdrawal-of-analgesic-medications-because-of-adverse-drug-reactions-a-systematic-review
#12
Igho J Onakpoya, Carl J Heneghan, Jeffrey K Aronson
Many analgesics have been withdrawn from the market because of adverse drug reactions. Controversy still surrounds the use of some approved analgesics for pain management. However, the trends and reasons for withdrawal of analgesics when harms are attributed to their use have not been systematically assessed. Areas covered: We conducted searches in PubMed; Embase; Google Scholar; clinicaltrials.gov; WHO databases of withdrawn products; websites of the European Medicines Agency, the US Food and Drug Administration, the UK Medicines and Healthcare products Regulatory Agency; Meyler's Side Effects of Drugs; Stephens' Detection of New Adverse Drug Reactions; the Pharmaceutical Manufacturing Encyclopedia; and the Merck Index...
November 1, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29082802/drug-drug-interactions-as-a-result-of-co-administering-%C3%AE-9-thc-and-cbd-with-other-psychotropic-agents
#13
Carola Rong, Nicole E Carmona, Yena L Lee, Renee-Marie Ragguett, Zihang Pan, Joshua D Rosenblat, Mehala Subramaniapillai, Margarita Shekotikhina, Fahad Almatham, Asem Alageel, Rodrigo Mansur, Roger C Ho, Roger S McIntyre
To determine, via narrative, non-systematic review of pre-clinical and clinical studies, whether the effect of cannabis on hepatic biotransformation pathways would be predicted to result in clinically significant drug-drug interactions (DDIs) with commonly prescribed psychotropic agents. Areas covered: A non-systematic literature search was conducted using the following databases: PubMed, PsycInfo, and Scopus from inception to January 2017. The search term cannabis was cross-referenced with the terms drug interactions, cytochrome, cannabinoids, cannabidiol, and medical marijuana...
October 31, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29065722/perindopril-arginine-and-amlodipine-besylate-for-hypertension-a-safety-evaluation
#14
William J Elliott, Evgeny A Bistrika
Controlling blood pressure is a global health priority; single-pill antihypertensive combinations may improve adherence, persistence, and outcomes. Areas covered: A novel combination of perindopril arginine and amlodipine besylate was recently approved. A systematic review of the literature revealed its most common adverse effects as: peripheral edema (depending on the dose of amlodipine, but attenuated by perindopril), cough, dizziness and hypotension. Dose-dependent hyperkalemia, impairment of renal function (especially in renovascular hypertension), angioedema, and teratogenicity were derived from experience with other ACE-inhibitors...
October 31, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29058944/statin-drug-interactions-and-related-adverse-reactions-an-update
#15
Stefano Bellosta, Alberto Corsini
Statins reduce the risk of cardiovascular morbidity and mortality in patients with or at risk for cardiovascular disease and their use is expanding, especially in elderly. Statins are prescribed on a long-term basis and may undergo drug-drug interactions (DDIs) with other drugs. Statins have different safety and tolerability, and this might affect the possibility of DDIs with other cardiovascular drugs, increasing the risk of statin-associated myopathy and hepatotoxicity. Polypharmacy and pharmacogenetic variability are potential causes of statin DDIs...
October 30, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29072544/a-narrative-review-of-the-safety-concerns-of-deprescribing-in-older-adults-and-strategies-to-mitigate-potential-harms
#16
Emily Reeve, Frank Moriarty, Rayan Nahas, Justin P Turner, Lisa Kouladjian O'Donnell, Sarah N Hilmer
As with prescribing or continuing medications, deprescribing brings with it the potential for harm as well as benefit. Uncertainty and avoidance of harm has been reported as a barrier to deprescribing in practice and may contribute to continuation of inappropriate medications. Areas covered: This narrative review covers four main safety concerns/potential harms of deprescribing in older adults: adverse drug withdrawal events, return of medical condition(s), reversal of drug-drug interactions and damage to the doctor-patient relationship...
October 26, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29065721/the-safety-of-treatments-used-in-pyoderma-gangrenosum
#17
Steve R Feldman, Frank A Lacy, William W Huang
Pyoderma gangrenosum (PG) is a severe ulcerating orphan dermatosis characterized by painful and rapidly progressive skin ulcers often associated with underlying inflammatory disease. Areas covered: In this article, we review and analyze the literature regarding treatment options for patients with PG, with particular attention to the efficacy and safety of therapies. Despite the significance of this problem, there are few studies devoted to the efficacy or safety of therapeutics in PG. We aim to present and evaluate existing studies and reports, and to make treatment recommendations based on the efficacy and safety data reviewed...
October 25, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29053927/safety-of-pharmacotherapy-options-for-bulimia-nervosa-and-binge-eating-disorder
#18
Nicholas T Bello, Bryn L Yeomans
Eating disorders represent a set of psychiatric illnesses with lifelong complications and high relapse rates. Individuals with eating disorders are often stigmatized and clinicians have a limited set of treatments options. Pharmacotherapy has the potential to improve long term compliance and patient commitment to treatment for eating disorders. Areas Covered: This review will examine the efficacy and safety profile of the FDA-approved medications for the treatment of bulimia nervosa (BN) and binge eating disorder (BED)...
October 20, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29050517/the-safety-and-efficacy-of-dabrafenib-and-trametinib-for-the-treatment-of-melanoma
#19
Sarah Knispel, Lisa Zimmer, Theodora Kanaki, Selma Ugurel, Dirk Schadendorf, Elisabeth Livingstone
The introduction of BRAF and MEK inhibitors into clinical practice improved the prognosis of metastatic melanoma patients. The combination of BRAF inhibitor dabrafenib with MEK inhibitor trametinib has shown its superiority to single agent therapy and is characterized by a tolerable spectrum of adverse events which shows a decrease in incidence over time on treatment. Areas covered: The current scientific literature on safety and adverse events (AEs) related to BRAF and MEK-inhibition has been investigated with special focus on the large phase 3 studies (COMBI-v, COMBI-d and CoBRIM) as well as recent updates presented at oncology and melanoma meetings...
October 20, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/29046068/corrigendum
#20
(no author information available yet)
No abstract text is available yet for this article.
October 18, 2017: Expert Opinion on Drug Safety
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