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Expert Opinion on Drug Safety

Sara Romano, Sergio Buccheri, Roxana Mehran, Dominick J Angiolillo, Davide Capodanno
Despite the significant advances in the pharmacological and interventional management of patients with cardiovascular disease (CVD) over the last decades, cardiovascular mortality remains the leading cause of death. Large randomized clinical trials have investigated the efficacy and safety of different antithrombotic medications in patients with CVD. Although female gender is generally under-represented in these clinical trials, most analyses clearly indicate that both men and women may accrue therapeutic benefits from antithrombotic management strategies...
September 18, 2018: Expert Opinion on Drug Safety
Shinji Matsunaga, Taro Kishi, Ikuo Nomura, Kenji Sakuma, Makoto Okuya, Toshikazu Ikuta, Nakao Iwata
Currently, five pharmacotherapeutic options are available to treat Alzheimer's disease: memantine; the three cholinesterase inhibitors donepezil, galantamine, and rivastigmine; and combination treatments with memantine and one cholinesterase inhibitor. Selection of the best course of treatment is based upon the evidence gathered by systematic reviews and meta-analyses of randomized controlled trials. Areas covered: This article provides a risk-benefit analysis of these treatments using evidence from meta-analyses on their safety and their efficacy...
September 17, 2018: Expert Opinion on Drug Safety
Khac-Dung N Guyen, Bahador Bagheri, Haleh Bagheri
Drug-induced bone loss remains the major cause of vertebral and hip fractures and significantly associated to morbidity and mortality. This article will review the common drugs identified as the causes of bone loss and the risk factors and management in European countries. Areas covered: Apart from glucorticoid - the most reputed cause of osteoporosis, many different drugs could cause harmful skeletal disorders. The antiepileptics, hormonal therapy, GnRH antagonists, aromatase inhibitors are well-known cause of bone loss...
September 17, 2018: Expert Opinion on Drug Safety
Pyoyoon Kang, Young-Eun Jang, Eun-Hee Kim, Ji-Hyun Lee, Jin-Tae Kim, Hee-Soo Kim
BACKGROUND: Although the requirement of propofol in children is increasing, propofol for induction and maintenance of anesthesia below 3 years old has not been approved in Korea. This study can provide a clinical evidence to increase the range of approval. RESEARCH DESIGN AND METHODS: We reviewed the medical records of patients below 3 years of age who underwent surgery between September 2013 and December 2016. Safety was evaluated on the basis of vital signs, and laboratory findings and efficacy were evaluated on the basis of the bispectral index (BIS)...
September 15, 2018: Expert Opinion on Drug Safety
Theresa Allio
No abstract text is available yet for this article.
September 12, 2018: Expert Opinion on Drug Safety
Adamantia Liapikou, Catia Cilloniz, Antoni Torres
Community-acquired pneumonia (CAP), a major cause of morbidity and mortality, is the leading infectious cause of death in the developed world. Population-based studies and systematic reviews have identified a large number of risk factors for the development of pneumonia in adults. In addition to age, lifestyle habits, and comorbidities, some forms of pharmacotherapy may also increase the risk for CAP. Areas covered: MEDLINE, CENTRAL, and Web of Science were used in 2017 to search for case-control, cohort studies, as well as randomized controlled trials and meta-analysis that involved outpatient proton pump inhibitors (PPIs), inhaled corticosteroids (ICSs), antipsychotics, oral antidiabetics, and CAP diagnosis in patients aged > 18 years...
September 10, 2018: Expert Opinion on Drug Safety
Fahadullah Khan, Mohammad Ismail, Qasim Khan, Zahid Ali
Moxifloxacin is widely used for the treatment of a number of infectious diseases because of its favorable pharmacological profile and high clinical success rate. However, it is often criticized for its higher risk of QTc interval prolongation (QTIP) and torsades de pointes (TdP). Areas covered: A review of published literature on moxifloxacin-related QTIP and TdP. Readers will be provided with a comprehensive overview of the prevalence, cellular mechanism, risk factors and magnitude of QTIP of moxifloxacin...
September 7, 2018: Expert Opinion on Drug Safety
Anita L Nelson
Although only a minority of contracepting women rely solely on spermicides, they may soon be the only ongoing female method available without a prescription in the United States. Spermicides are also combined with other methods for additional pregnancy protection and/or lubrication. Nonoxynol-9 (N-9), the active ingredient in most spermicides, is cytotoxic and may increase risk of transmission of HIV and other sexually transmitted infections, especially in high-risk women. Amphora (previously called Acidform) is a noncytotoxic spermicide composed of a series of generally regarded as safe compounds, which maintains the acidity of the vagina following coitus to immobilize and kill sperm...
September 3, 2018: Expert Opinion on Drug Safety
Antonis A Manolis, Theodora A Manolis, Dimitri P Mikhailidis, Antonis S Manolis
Patients with cancer are subject to the cardiotoxic effects of cancer therapy and as more patients survive cancer due to improved treatment they are exposed to various forms of cardiovascular (CV) disease as they age, and vice-versa. Such an interplay of age with both malignancy and CV disease may contribute to increased morbidity and mortality. Areas covered: This two-part review considers the effects of cancer drug treatment on the CV system. In Part I, the various types of CV and cardiometabolic toxicity of anti-cancer drugs and the possible mechanisms involved are discussed...
September 1, 2018: Expert Opinion on Drug Safety
Romina Moavero, Laura Rosa Pisani, Francesco Pisani, Paolo Curatolo
Treatment of paediatric epilepsy requires a careful evaluation of the safety and tolerability profile of antiepileptic drugs (AEDs) to avoid or minimize as much as possible adverse events (AEs) on various organs, haematological parameters, and growth, pubertal, motor, cognitive and behavioural development. Areas covered: Treatment emergent AEs (TEAEs) reported in the literature 2000-2018 regarding second and third generation AEDs used in the paediatric age, with exclusion of the neonatal period that exhibits specific peculiarities, have been described on the basis of their frequency, severity/tolerability, and particular association with a given AED...
August 31, 2018: Expert Opinion on Drug Safety
Gabriela Andries, Srikanth Yandrapalli, Wilbert S Aronow
Heart failure (HF) is an important public health problem with an increasing prevalence across the globe. The mortality rates from this complex clinical problem have stabilized in the recent years with the use of pharmacotherapeutics which demonstrated survival benefits in patients with HF with reduced ejection fraction (HFrEF). Areas covered: We reviewed the seven classes of medications which constitute the guideline-directed medical therapy (GDMT) in chronic HF patients. We discussed clinical trials which support or contradict their use, potential adverse events, and available real-world data on utilization and safety...
August 31, 2018: Expert Opinion on Drug Safety
Guldane Cengiz Seval, Meral Beksac
There is now 16 years' worth of established results of various trials demonstrating the bortezomib efficiency in the treatment of multiple myeloma. Over this time, the introduction of bortezomib has been a major break through in the treatment of multiple myeloma. Bortezomib can be administered in the outpatient setting with manageable toxicities. Areas covered: A literature search was carried out using PubMed and Google Scholar. This review gives an overview of the critical role of the bortezomib in multiple myeloma and provides a comprehensive summary of key clinical benefit and safety data with the bortezomib...
August 30, 2018: Expert Opinion on Drug Safety
Reynold D C Francisca, Inge M Zomerdijk, Miriam C J M Sturkenboom, Sabine M J M Straus
AIMS: Additional risk minimization measures (aRMMs) may be needed to ensure that the benefits continue to outweigh the risks for medicines associated with serious risks. Prior research showed an increasing trend in medicines with aRMMs. We assessed whether the European pharmacovigilance legislation may have impacted the number and type of aRMMs. METHODS: We included new active substances approved between 1 January 2010 and 31 December 2015. Information extracted from the summary of the Risk Management Plan at the time of licensing included date and type of marketing authorization, presence and type of aRMMs...
August 22, 2018: Expert Opinion on Drug Safety
Fernando Rizzello, Marta Mazza, Marco Salice, Carlo Calabrese, Andrea Calafiore, Massimo Campieri, Paolo Gionchetti
Beclomethasone dipropionate (BDP) is a second-generation corticosteroid that uses novel drug technologies to ensure colonic targeting and potentially reducing systemic corticosteroid concentrations. It is approved for treatment of patients with mild-to-moderate ulcerative colitis (UC) who do not respond to mesalazine. The gut-selective mechanism of action has the potential to improve the safety profile of BDP compared with other conventional corticosteroids. Areas covered: We reviewed the mechanism of action, efficacy, and safety of BDP in the treatment of UC...
August 21, 2018: Expert Opinion on Drug Safety
Antonis A Manolis, Theodora A Manolis, Dimitri P Mikhailidis, Antonis S Manolis
Cancer patients are subject to the cardiotoxic effects of cancer therapy. Improved treatments lead to more cancer-survivors, though are exposed to various forms of cardiovascular (CV) disease (CVD) as they age. Aging patients are at increased risk of developing both malignancy and CVD or they may have survived some form of CVD as a result again of effective treatments. Furthermore, patients with CVD may develop cancer and require treatment, all contributing to increased morbidity and mortality. Both malignancy and CVD will increase due to trend towards a longer lifespan...
August 20, 2018: Expert Opinion on Drug Safety
David E Moody
In the 1980-90s numerous studies were performed on H2 -receptor antagonist inhibition of ethanol first pass metabolism. Blood alcohol concentrations warranting possible driving under the influence citations in the United States have subsequently dropped from ≥ 100 mg/dL to 50 mg/dL (Utah in 2019) (30 mg/dL or zero tolerance in some parts of the world). A reexamination of these studies seemed important. Areas covered: Papers were compiled that addressed the effect of cimetidine, ranitidine, famotidine, and nizatidine on ethanol metabolism first from a PubMed search and then from citations within these papers...
August 17, 2018: Expert Opinion on Drug Safety
Alba Noguerido, Núria Mulet-Margalef, Ignacio Matos, Javier Ros, Guillem Argilés, Elena Élez, Josep Tabernero
Ramucirumab, a human monoclonal antibody against vascular endothelial growth factor receptor 2 (VEGFR-2), is an antiangiogenic therapy that has been approved in combination with FOLFIRI in second-line treatment of metastatic colorectal cancer (mCRC), after progression on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. A thorough review of the safety of ramucirumab in this setting and in the context of other antiangiogenic agents is merited. Areas covered: We provide an overview of activity and summarize in detail the overall safety and tolerability profile of ramucirumab in mCRC patients on the basis of a literature review of all published clinical trials in this setting, including both single-agent and combination studies...
August 16, 2018: Expert Opinion on Drug Safety
Brahim Azzouz, Malak Abou Taam, Aurore Morel, Thierry Trenque
BACKGROUND: Angiotensin receptor blockers (ARBs) can induce or exacerbate psoriasis. Psoriasis is unlisted in the Summary of Product Characteristics (SmPC) of ARBs. We aimed to investigate the association between psoriasis and ARB exposure. METHODS: We reviewed spontaneous reports recorded in the French national Pharmacovigilance Database (FPVD). The association between psoriasis and ARB exposure was assessed using the case/non-case method. We also analyzed literature reports...
August 11, 2018: Expert Opinion on Drug Safety
Ippazio Cosimo Antonazzo, Emanuel Raschi, Emanuele Forcesi, Trond Riise, Kjetil Bjornevik, Elisa Baldin, Fabrizio De Ponti, Elisabetta Poluzzi
BACKGROUND: Possible relationship between drug exposure and multiple sclerosis (MS) development is insufficiently investigated, and further challenged by the incomplete understanding of MS etiopathogenesis. The study aims to investigate whether drug exposure could contribute to MS, by analyzing worldwide spontaneous reporting archives of adverse drug reaction (ADRs). RESEARCH DESIGN AND METHODS: We retrieved information from the US Food and Drug Administration Adverse Event Reporting System (FAERS) over a 13-year period...
August 11, 2018: Expert Opinion on Drug Safety
R Scooter Plowman, Timothy Peters-Strickland, George M Savage
No abstract text is available yet for this article.
August 3, 2018: Expert Opinion on Drug Safety
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