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Expert Opinion on Drug Safety

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https://www.readbyqxmd.com/read/27910704/the-safety-of-nivolumab-for-the-treatment-of-advanced-non-small-cell-lung-cancer
#1
Giulio Metro, Biagio Ricciuti, Marta Brambilla, Sara Baglivo, Irene Soli, Elisa Minenza, Giulia Costanza Leonardi, Alessandro D'Arpino, Daniela Colabrese, Marco Tazza, Daniela Zicari, Vincenzo Minotti, Rita Chiari
Immune checkpoint blockaders (ICBs) act by unbalancing the immune system, thus favoring the development of an immune-mediated antitumor effect. ICBs targeting the programmed cell death receptor-1 (PD-1) have recently been investigated in a number of advanced tumors, including non-small cell lung cancer (NSCLC). Nivolumab, a fully human IgG4 kappa directed against PD-1, has been the first ICB to be approved for second-line treatment of advanced NSCLC. Areas covered: In this review we focus on the clinical development of nivolumab for the treatment of advanced NSCLC, with an emphasis on its safety profile...
December 2, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27813420/exploiting-heterogeneous-publicly-available-data-sources-for-drug-safety-surveillance-computational-framework-and-case-studies
#2
Vassilis G Koutkias, Agnès Lillo-Le Louët, Marie-Christine Jaulent
OBJECTIVE: Driven by the need of pharmacovigilance centres and companies to routinely collect and review all available data about adverse drug reactions (ADRs) and adverse events of interest, we introduce and validate a computational framework exploiting dominant as well as emerging publicly available data sources for drug safety surveillance. METHODS: Our approach relies on appropriate query formulation for data acquisition and subsequent filtering, transformation and joint visualization of the obtained data...
December 1, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27852118/risk-of-arterial-and-venous-occlusive-events-in-chronic-myeloid-leukemia-patients-treated-with-new-generation-bcr-abl-tyrosine-kinase-inhibitors-a-systematic-review-and-meta-analysis
#3
Hélène Haguet, Jonathan Douxfils, François Mullier, Christian Chatelain, Carlos Graux, Jean-Michel Dogné
BACKGROUND: A previous meta-analysis demonstrated that 3 of the new-generation BCR-ABL tyrosine kinase inhibitors (TKIs) (dasatinib, nilotinib and ponatinib) are associated with an increased risk of vascular occlusive events in patients with Ph+ chronic myeloid leukemia compared with imatinib. This meta-analysis of randomized controlled trials aims at assessing these risks separately. METHODS: The literature search was performed by two independent reviewers following the previous protocol (PROSPERO 2014:CRD42014014147)...
November 28, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27885844/guidance-to-manage-inappropriate-polypharmacy-in-older-people-systematic-review-and-future-developments
#4
Derek Stewart, Alpana Mair, Martin Wilson, Przemyslaw Kardas, Pawel Lewek, Albert Alonso, Jennifer McIntosh, Katie MacLure
Single disease state led evidence-based guidelines do not provide sufficient coverage of issues of multimorbidities, with the cumulative impact of recommendations often resulting in overwhelming medicines burden. Inappropriate polypharmacy increases the likelihood of adverse drug events, drug interactions and non-adherence. Areas covered: A detailed description of a pan-European initiative, 'Stimulating Innovation Management of Polypharmacy and Adherence in the Elderly, SIMPATHY', which is a project funded by the European Commission to support innovation across the European Union...
November 25, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27880061/the-safety-profile-of-monoclonal-antibodies-for-chronic-lymphocytic-leukemia
#5
Anna Korycka-Wołowiec, Dariusz Wołowiec, Tadeusz Robak
Monoclonal antibodies (MoAbs), non-chemotherapeutic agents targeting the antigens present on chronic lymphocytic leukemia (CLL) lymphocytes, are being implemented increasingly more often as treatment options. Areas covered: This article reviews the similarities and differences in the structure, mechanism of action, efficacy and safety profile of commercially-available MoAbs and prevents new agents potentially useful for CLL treatment. Publications in English before June 2016 were surveyed on the MEDLINE database for articles...
November 23, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27855534/campania-preventability-assessment-committee-a-focus-on-the-preventability-of-the-contrast-media-adverse-drug-reactions
#6
Maurizio Sessa, Claudia Rossi, Concetta Rafaniello, Annamaria Mascolo, Daniela Cimmaruta, Cristina Scavone, Sonia Fiorentino, Enrico Grassi, Alfonso Reginelli, Antonio Rotondo, Liberata Sportiello
OBJECTIVE: The current study aims to assess the preventability of the contrast media adverse drug reactions reported through the Campania spontaneous reporting system, identifying the possible limitations emerged in this type of evaluation. METHOD: All the individual case safety reports validated by the Campania Pharmacovigilance Regional Centre from July 2012 to September 2015 were screened to select those that reported contrast media as suspected drug. Campania Preventability Assessment Committee, in collaboration with clinicians specialized in Radiology, assessed the preventability according to the P-Method, through a case-by-case approach...
November 18, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27841029/safety-of-proteasome-inhibitors-for-treatment-of-multiple-myeloma
#7
Danielle Schlafer, Katherine S Shah, Elyse Hall Panjic, Sagar Lonial
Proteasome inhibitors (PIs) have revolutionized the treatment of multiple myeloma and are a backbone of therapy. Bortezomib, the first PI approved, has shown efficacy in both front-line and relapsed/refractory settings however the development of resistance and side effects such as peripheral neuropathy can limit its use. The second generation PIs carfilzomib and ixazomib, both approved in relapsed/refractory cases, may help to overcome resistance mechanisms and increase tolerability. While bortezomib is approved to be administered intravenously (IV) or subcutaneously (SC) and carfilzomib IV, ixazomib is the first and only approved PI that is orally bioavailable...
November 14, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27830951/drug-induced-blood-pressure-increase-recommendations-for-assessment-in-clinical-and-non-clinical-studies
#8
Christer Gottfridsson, Seva Panfilov, Ahmad Ebrahimi, Emery Gigger, Chris Pollard, Simon Henderson, Philip Ambery, Joel S Raichlen
Changes in blood pressure (BP) are now proactively examined throughout the drug development process as an integral aspect of safety monitoring. This is because hypertension is a very strong risk factor for cardiovascular events and drug-induced increases in BP have attracted increased regulatory attention. However, there is currently no guidance from regulatory agencies on the minimum BP data required for submissions, and there are no specific criteria for what constitutes a safety signal for increased BP in non-clinical studies...
November 10, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27750459/riociguat-for-the-treatment-of-pulmonary-hypertension-a-safety-evaluation
#9
Christina Binder, Caroline Zotter-Tufaro, Diana Bonderman
The development of pulmonary hypertension (PH) has multifactorial underlying pathophysiological causes and can be classified into five groups. While three different classes of therapeutic drugs are licensed for the treatment of pulmonary arterial hypertension (PAH, WHO group 1), specific medical therapies are lacking for other forms of PH, such as PH due to left heart disease. In 2013 riociguat, a first-in class soluble guanylate cyclase stimulator, has also become available for the treatment of PAH. Riociguat was further introduced as the first approved pharmacotherapy for the treatment of patients with chronic thromboembolic PH (WHO group 4, CTEPH)...
November 9, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27645494/severity-of-statin-induced-adverse-effects-on-muscle-and-associated-conditions-data-from-the-dama-study
#10
Juan Pedro-Botet, Jesús Millán Núñez-Cortés, Juan J Chillarón, Juana A Flores-Le Roux, Joan Rius
BACKGROUND: Statins are generally well tolerated, but muscular adverse effects appear to be the most common obstacle limiting their use. Our objective was to describe the severity of muscle injury (myalgia, myositis and rhabdomyolysis) and associated conditions related to statin therapy that may be clinically significant. METHODS: A cross-sectional one-visit, non-interventional, national multicenter study including patients of both sexes over 18 years of age referred for past or present muscle symptoms associated with statin therapy was conducted...
October 24, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27756172/safety-of-monoclonal-antibodies-for-the-treatment-of-multiple-sclerosis
#11
Marisa P McGinley, Brandon P Moss, Jeffrey A Cohen
Monoclonal antibodies are a potent therapeutic approach for relapsing-remitting multiple sclerosis. This group of medications comprises diverse mechanisms of action resulting in both shared and unique adverse effects. Areas covered: The major trials and safety profiles of natalizumab, alemtuzumab, daclizumab, rituximab, and ocrelizumab are discussed. While each drug has a unique safety profile, one of the potential safety concerns for all of these drugs is infection, including for some progressive multifocal leukoencephalopathy...
October 19, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27737601/immunogenicity-of-tnf-alpha-inhibitors-in-rheumatology-many-questions-enough-answers
#12
Daniel Wendling, Frank Verhoeven, Xavier Guillot, Clément Prati
No abstract text is available yet for this article.
October 13, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27737598/the-safety-of-anti-pd-1-therapeutics-for-the-treatment-of-melanoma
#13
Egle Ramelyte, Sabrina A Schindler, Reinhard Dummer
Introduction The introduction of immunotherapies into clinical practice has substantially improved the prognosis of metastatic melanoma patients as well as patients suffering from other cancers. The two FDA-approved checkpoint inhibitors against PD-1 (nivolumab and pembrolizumab) have been shown to significantly improve patient survival while being less toxic than previous treatment options. Areas covered The current scientific literature on safety and adverse events (AEs) related to anti-PD-1 therapies has been investigated with special attention to case reports and to the latest results announced at the major clinical cancer and melanoma meetings, including ASCO (American Society of Clinical Oncology), ESMO (European Society of medical Oncology) and EADO (European Association of Dermato-Oncology) annual meetings...
October 13, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27737595/hyponatremia-induced-by-antiepileptic-drugs-in-patients-with-epilepsy
#14
Xi Lu, Xuefeng Wang
Hyponatremia induced by antiepileptic drugs (AEDs) has not received sufficient attention in patients with epilepsy. Areas covered: We reviewed articles between 1966 and 2015 about hyponatremia as an adverse effect of AEDs in patients with epilepsy. The incidence, clinical symptoms, onset times of AEDs-induced hyponatremia are discussed in detail, as are the risk factors associated with AEDs-induced hyponatremia and mechanisms underlying its development. We also briefly describe strategies for treating AED-induced hyponatremia...
October 13, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27732121/safety-assessment-of-combination-therapies-in-the-treatment-of-obesity-focus-on-naltrexone-bupropion-extended-release-and-phentermine-topiramate-extended-release
#15
Bruno Halpern, Marcio C Mancini
Few studies on combination therapies for the treatment of obesity had been conducted until recently, when two fixed-dose combinations, bupropion-naltrexone ER fixed-dose combination and phentermine-topiramate ER titrated-dose combinations were evaluated in clinical studies that ultimately led to FDA approval. Areas covered: In this review, we discuss safety concerns about both combinations, the rationale and history of combination therapies for obesity (including phentermine plus fenfluramine), and possible future new combinations...
October 12, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27732110/a-review-of-the-national-pharmacovigilance-system-in-malta-implementing-and-operating-a-pharmacovigilance-management-system
#16
Amy Tanti, Benjamin Micallef, Anthony Serracino-Inglott, John-Joseph Borg
Regulatory authorities have a legal mandate to implement and maintain a Pharmacovigilance System designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. Areas covered: This review maps the implementation of pharmacovigilance activities in Malta since accession in the EU in mid 2004 and discusses the challenges the Maltese Regulator encountered while setting up adequate and effective systems to fulfil its legal mandate. Areas reviewed are those around ADR reporting, promotion and safety communications including rapid alerts and recalls, direct healthcare professional communications, risk minimisation measures and safety circulars and quality systems...
October 12, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27648959/adverse-safety-events-in-patients-with-chronic-kidney-disease-ckd
#17
Ada Offurum, Lee-Ann Wagner, Tanisha Gooden
Chronic kidney disease (CKD) confers a higher risk of adverse safety events as a result of many factors including medication dosing errors and use of nephrotoxic drugs, which can cause kidney injury and renal function decline. CKD patients may also have comorbidities such as hypertension and diabetes for which they require more frequent care from different providers, and for which standard, but countervailing treatments, may put them at risk for adverse safety events. Areas covered: In addition to the well-known agents such as iodinated radiocontrast, antimicrobials, diuretics and angiotensin converting enzyme (ACE) inhibitors which can directly affect renal function, safety considerations in the treatment of common CKD complications such as anemia, diabetes, analgesia and thrombosis will also be discussed...
October 12, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27728981/the-safety-of-pregabalin-in-the-treatment-of-fibromyalgia
#18
Maria Chiara Gerardi, Fabiola Atzeni, Alberto Batticciotto, Manuela Di Franco, Maurizio Rizzi, Piercarlo Sarzi-Puttini
Pregabalin is indicated for the treatment of fibromyalgia and pregabalin-treated subjects have shown improved pain, sleep and functional measures in placebo-controlled and open-label studies. This article reviews pregabalin's safety profile. Areas covered: The safety findings in pregabalin clinical trials were accessed by a PubMed search using the key words 'pregabalin' or 'anti-epilectics drug' or 'gabapentinoids' or 'anticonvulsants' and 'fibromyalgia'. Although frequent, the side effects of pregabalin therapy are usually mild to moderate, well tolerated in the long term, and can be monitored in a primary care setting...
October 11, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27689239/treatment-options-for-hypertension-in-pregnancy-and-puerperium
#19
Farah H Amro, Hind N Moussa, Olaide A Ashimi, Baha M Sibai
Hypertensive disorders have become increasingly prevalent and complicate an increasing number of pregnancies. Therefore it is essential that the medications used to treat these disorders be well understood. Furthermore the management is complicated by special consideration needed for the physiologic changes of pregnancy as well as the consideration for possible adverse fetal effects. Areas covered: We performed a review of the scientific literature of medications used to treat hypertensive disorders in pregnancy...
October 11, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27718746/incidence-and-implications-of-chemotherapy-related-hand-foot-syndrome
#20
V Nikolaou, K Syrigos, M W Saif
Hand-foot syndrome (HFS) is a well-established cutaneous adverse event of certain chemotherapeutic agents, mainly capecitabine, continuously infused 5-fluorouracil, docetaxel and pegylated liposomal doxorubicin. Erythema, dysesthesia, pain, cracking and desquamation located on palms and soles are the most characteristic manifestations. Although HFS is a reversible and non-life-threatening clinical condition, it can often affect patient's quality of life significantly, hence necessitating therapeutic modifications or even treatment discontinuation...
October 8, 2016: Expert Opinion on Drug Safety
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