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Expert Opinion on Drug Safety

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https://www.readbyqxmd.com/read/28538107/local-anesthetics-systemic-toxicity-association-with-exparel-bupivacaine-liposome-a-pharmacovigilance-evaluation
#1
Nitish Aggarwal
BACKGROUND: Local Anesthetic Systemic Toxicity (LAST) is a rare life threatening complication usually from intra-arterial or intravenous injection leading to systemic absorption of regional anesthesia drug. The objective of this research was to statistically quantify the association between Exparel (bupivacaine liposome) injectable suspension and LAST. METHODS: Adverse Event Reporting System database of FDA, which houses public and industry submitted adverse event case reports, was queried and analyzed to quantify the passive pharmacovigilance signal for Local Anesthetic Systemic Toxicity as associated with use of bupivacaine Liposome...
May 24, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28538105/linezolid-induced-lactic-acidosis-the-thin-line-between-bacterial-and-mitochondrial-ribosomes
#2
Alessandro Santini, Dario Ronchi, Manuela Garbellini, Daniela Piga, Alessandro Protti
Introduction - Linezolid inhibits bacterial growth by targeting bacterial ribosomes and by interfering with bacterial protein synthesis. Lactic acidosis is a rare, but potentially lethal, side effect of linezolid. Areas covered - The pathogenesis of linezolid-induced lactic acidosis is reviewed with special emphasis on aspects relevant to the recognition, prevention and treatment of the syndrome. Expert opinion - Linezolid-induced lactic acidosis reflects the untoward interaction between the drug and mitochondrial ribosomes...
May 24, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28535693/experience-with-sunitinib-in-metastatic-renal-cell-carcinoma-mrcc-patients-pooled-analysis-from-3-spanish-observational-prospective-studies
#3
Daniel Castellano, José Pablo Maroto, Enrique Espinosa, Enrique Grande, Victoria Bolos, Julia Linares, Emilio Esteban, Aranzazu Gonzalez Del Alba, M A Climent, J A Arranz, Mª José Méndez, Eva Fernadez Parra, Luis Antón-Aparicio, Cristina Bayona, Isabel Gallegos, Enrique Gallardo, Luz Samaniego, J Garcia Donas
BACKGROUND: A pivotal, randomized, phase III trial demonstrated a statistically significant superiority of sunitinib over interferon-α in metastatic renal cell carcinoma (mRCC) patients. OBJECTIVE: To evaluate the effectiveness and safety of sunitinib in patients with advanced or mRCC in routine clinical practice. METHODS: Retrospective pooled analysis of clinical data from three observational and prospective studies carried out between 2007 and 2011 in 33 Spanish hospitals...
May 24, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28504555/frequency-and-characteristics-of-infusion-reactions-during-biosimilar-infliximab-treatment-in-inflammatory-bowel-diseases-results-from-central-european-nationwide-cohort
#4
Anita Bálint, Mariann Rutka, Zsuzsanna Végh, Zsuzsanna Kürti, Krisztina B Gecse, János Banai, László Bene, Beáta Gasztonyi, Tünde Kristóf, László Lakatos, Pál Miheller, Károly Palatka, Árpád Patai, Ágnes Salamon, Tamás Szamosi, Zoltán Szepes, Gábor Tamás Tóth, Áron Vincze, Renáta Bor, Ágnes Milassin, Anna Fábián, Ferenc Nagy, Martin Kolar, Martin Bortlik, Dana Duricova, Veronika Hruba, Martin Lukas, Katarina Mitrova, Karin Malickova, Milan Lukas, Péter L Lakatos, Tamás Molnár, Klaudia Farkas
INTRODUCTION: Safety data of the 'real life' use of an infliximab biosimilar, CT-P13 in inflammatory bowel disease (IBD) are still lacking. Our aim was to assess the frequency and characteristics of infusion reactions during CT-P13 therapy in 13 Hungarian and 1 Czech IBD centres. METHODS: Clinical and safety data was registered at fixed appointments. Trough levels and anti-drug antibody (ADA) concentration were measured by ELISA. Association between demographic, clinical, laboratory parameters and infusion reaction rates were evaluated statistically...
May 15, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28494654/new-formulations-of-tacrolimus-and-prevention-of-acute-and-chronic-rejections-in-adult-kidney-transplant-recipients
#5
Lionel Rostaing, Thomas Jouve, Paolo Malvezzi
BACKGROUND: As tolerance is not yet achievable, the kidney-transplanted-patients have to take on a daily-basis immunosuppressive drugs in order to avoid acute rejection-AR-. The cornerstone of immunosuppression relies on tacrolimus-therapy which is potentially nephrotoxic. RESEARCH DESIGN AND METHODS: We identified from the studies published in the recent years those who were reporting on AR in de novo kidney-transplant recipients under tacrolimus-based therapy, as well as those who reported on the attempt to minimize tacrolimus-therapy...
May 11, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28447485/empirical-estimation-of-under-reporting-in-the-u-s-food-and-drug-administration-adverse-event-reporting-system-faers
#6
Yasser M Alatawi, Richard A Hansen
BACKGROUND: To examine how closely reporting rates in the FDA Adverse Event Reporting System (FAERS) reflect expected rates of known adverse drug events (ADEs). METHODS: We selected three groups of drugs to reflect hypothesized variation in sensitivity to reporting, including statins, biologics, and narrow therapeutics index drugs (NTI). The numbers of ADEs in FAERS were divided by utilization estimates from ambulatory health care data (NAMCS/NHAMCS) to calculate a reported proportion...
May 9, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28475380/thromboembolic-and-bleeding-risks-of-oral-anticoagulation-therapy-in-patients-undergoing-atrial-fibrillation-ablation
#7
David F Briceño, Nidhi Madan, Jorge Romero, Alejandra Londoño, Pedro A Villablanca, Andrea Natale, Luigi Di Biase
Atrial fibrillation (AF) is a cause of significant morbidity and mortality. Catheter ablation for AF (CAAF) has emerged as an effective treatment option of rhythm control for patients with symptomatic AF. However, the risk of thromboembolism and bleeding in the periprocedural period represent a worrisome complication of this therapy. The reported incidence of thromboembolic and bleeding events associated with CAAF varies from 0.9% to 5% depending on the CAAF strategy and the anticoagulation regimen used in the periprocedural period...
May 5, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28443354/optimization-of-intelligent-infusion-pump-technology-to-minimize-vasopressor-pump-programming-errors
#8
Nina Vadiei, Carrie A Shuman, Manasa S Murthy, Mitchell J Daley
STUDY OBJECTIVE: To determine if incorporation of vasopressor upper hard limits (UHL) into intelligent infusion pump technology (IIPT) increases efficacy of alerts by preventing pump programming errors. DESIGN & METHODS: Retrospective review from five hospitals within a single healthcare network between April 1, 2013 and May 31, 2014. A total of 65,680 vasopressor data entries were evaluated; 19,377 prior to hard limit implementation and 46,303 after hard limit implementation...
April 26, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28494686/clinical-pharmacology-efficacy-and-safety-of-selexipag-for-the-treatment-of-pulmonary-arterial-hypertension
#9
Shirin Bruderer, Noémie Hurst, Tatiana Remenova, Jasper Dingemanse
Selexipag is the first oral, non-prostanoid, selective prostacyclin receptor (IP receptor) agonist, approved for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients. Areas covered: This article reviews the clinical pharmacology, efficacy, and safety of selexipag in the treatment of PAH. Expert opinion: Selexipag is the first oral drug that selectively targets the prostacyclin pathway, and has evidence of long-term efficacy and safety. In the global phase 3 study GRIPHON (NCT01106014) in PAH patients, selexipag significantly reduced the risk of the primary composite outcome of morbidity/mortality (M/M)...
June 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28490262/methods-for-safety-signal-detection-in-healthcare-databases-a-literature-review
#10
Mickael Arnaud, Bernard Bégaud, Nicolas Thurin, Nicholas Moore, Antoine Pariente, Francesco Salvo
With increasing availability, the use of healthcare databases as complementary data source for drug safety signal detection has been explored to circumvent the limitations inherent in spontaneous reporting. Areas covered: To review the methods proposed for safety signal detection in healthcare databases and their performance. Expert opinion: Fifteen different data mining methods were identified. They are based on disproportionality analysis, traditional pharmacoepidemiological designs (e.g. self-controlled designs), sequence symmetry analysis (SSA), sequential statistical testing, temporal association rules, supervised machine learning (SML), and the tree-based scan statistic...
June 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28490215/the-safety-of-daratumumab-for-the-treatment-of-multiple-myeloma
#11
María J Cejalvo, Paz Ribas, Javier de la Rubia
The overall survival of patients with multiple myeloma (MM) has changed dramatically in the last decade. MM remains an incurable plasma cell disorder but immunotherapy with monoclonal antibodies (MoAbs) has emerged as a promising treatment. Areas covered: Fully published, clinical trials including patients with relapsed or refractory MM were reviewed. Safety data of daratumumab (DARA) single-agent or in combination regimens have been addressed. Additionally, infusion-related reactions, data on special populations, and DARA-interference with laboratory testing, including assessment of MM response in patients have also been addressed...
June 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28471314/hepatitis-b-reactivation-during-or-after-direct-acting-antiviral-therapy-implication-for-susceptible-individuals
#12
Jacinta A Holmes, Ming-Lung Yu, Raymond T Chung
The FDA issued a warning following 24 cases of HBV reactivation during DAA therapy for HCV, including individuals with inactive, occult and past HBV infection. Clinical presentations ranged from asymptomatic fluctuations in HBV DNA to fulminant hepatic failure, liver transplantation and death. The mechanism is unknown. Areas covered: HCV/HBV coinfection is common, particularly in regions endemic for HBV. HCV and HBV utilize host factors to support replication; both viruses evade/impair host immunity. Clinical presentations of HBV reactivation during DAAs are summarized...
June 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28471247/the-safety-of-antiangiogenic-agents-and-parp-inhibitors-in-platinum-sensitive-recurrent-ovarian-cancer
#13
Domenica Lorusso, Caterina Fontanella, Giuseppa Maltese, Stefano Lepori, Elisa Tripodi, Giorgio Bogani, Francesco Raspagliesi
Recurrence is a common event in endothelial ovarian cancer (EOC) patients, and the choice of the most appropriate treatment is driven by the platinum-free interval, molecular characteristics of the disease such as BRCA mutational status, previous treatments and toxicity. Areas covered: This review focuses on the main hematologic and non-hematologic toxicities correlated with the use of licensed antiangiogenic agents and PARP inhibitors in recurrent platinum-sensitive EOC, providing recommendations for their management...
June 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28467190/risk-of-gastrointestinal-bleeding-during-anticoagulant-treatment
#14
Aitor Lanas-Gimeno, Angel Lanas
Gastrointestinal bleeding (GIB) is a major problem in patients on oral anticoagulation therapy. This issue has become even more pressing since the introduction of direct oral anticoagulants (DOACs) in 2009. Areas covered: Here we review current evidence related to GIB associated with oral anticoagulants, focusing on randomized controlled trials, meta-analyses, and post-marketing observational studies. Dabigatran 150 mg twice daily and rivaroxaban 20 mg once daily increase the risk of GIB compared to warfarin...
June 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28460548/clinical-pharmacology-of-neurokinin-1-receptor-antagonists-for-the-treatment-of-nausea-and-vomiting-associated-with-chemotherapy
#15
Bernardo Rapoport, Teresa Smit
Five NK-1 RA formulations are commercially available to treat the delayed phase of chemotherapy-induced nausea and vomiting (CINV) occurring between days 2-5 post chemotherapy (aprepitant oral capsule and suspension, fosaprepitant intravenous infusion, netupitant/palonosetron capsules and rolapitant tablet) but no direct comparative studies have been conducted to determine their relative clinical utility. Areas covered: Information on pharmacology and safety of the NK-1 RAs derived from PubMed showed that all bind the NK-1 receptor with high affinity and selectivity...
June 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28447490/risks-and-benefits-of-pre-operative-dexmedetomidine-in-oral-and-maxillofacial-surgeries-a-systematic-review
#16
Amin Davoudi, Bijan Movahedian Attar, Elham Shadmehr
Oral and maxillofacial surgeries might induce anxiety and pain to the patients. Sedative agents are one of the best ways for eliminating such consequences. Dexmedetomidine (DEX) is a recent sedative agent which presents higher sedative quality with greater specificity than other drugs. The aim of present paper is to evaluate the risks and benefits of administrating DEX during oral and maxillofacial surgeries by reviewing high quality released articles. Areas covered: Searches on PubMed, Scopus and Web of Science databases were completed with focus on randomized controlled trials (RCT)...
June 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28441904/the-safety-of-ustekinumab-for-the-treatment-of-psoriatic-arthritis
#17
A López-Ferrer, A Laiz, L Puig
The cytokines interleukin (IL)-12 and IL-23 have been involved in the pathogenesis of psoriasis and psoriatic arthritis. Ustekinumab is a fully human monoclonal antibody targeting the p40 subunit shared by IL-12 and IL-23. Ustekinumab prevents the interaction of IL-12 and IL-23 binding to their receptors, blocking the T1 and T17 inflammatory pathways. Ustekinumab has been evaluated for the treatment of various chronic immune mediated diseases including psoriasis and psoriatic arthritis (PsA). Most of the data regarding the safety of ustekinumab come from the experience treating patients with psoriasis, but clinical trials have demonstrated its efficacy and safety in the treatment of both diseases...
June 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28395515/long-term-safety-experience-with-bendamustine-for-injection-in-a-real-world-setting
#18
Peter Martin, Paul M Barr, Leonard James, Ashutosh Pathak, Brad Kahl
BACKGROUND: Bendamustine hydrochloride (bendamustine) was approved for first-line treatment of patients with chronic lymphocytic leukemia (CLL) and relapsed indolent B-cell non-Hodgkin's lymphoma (NHL). Pharmacovigilance data have been collected since bendamustine's approval to enhance understanding of its long-term safety profile. Here we provide an overview of the pharmacovigilance data for bendamustine that have led to label updates related to safety and administration since its approval...
June 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28471295/erratum
#19
(no author information available yet)
No abstract text is available yet for this article.
May 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28395526/ramucirumab-in-the-treatment-of-non-small-cell-lung-cancer
#20
Oscar Arrieta, Zyanya Lucia Zatarain-Barrón, Andrés F Cardona, Amir Carmona, Mariana Lopez-Mejia
Therapeutic options for treating Non-Small Cell Lung Cancer (NSCLC) have recently increased. Ramucirumab (Cyramza), an anti-angionenic agent was approved in 2014 for treatment of several malignancies, including second-line treatment of patients with NSCLC with disease progression on or after platinum-based chemotherapy. Areas covered: We performed a comprehensive search of the literature focused on clinical trials with use of ramucirumab, targeting its evolution in the treatment of NSCLC. This review summarizes the results regarding its safety and efficacy...
May 2017: Expert Opinion on Drug Safety
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