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Expert Opinion on Drug Safety

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https://www.readbyqxmd.com/read/30412009/should-real-world-evidence-be-incorporated-into-regulatory-approvals
#1
Ernest Spitzer, Christopher P Cannon, Patrick W Serruys
No abstract text is available yet for this article.
November 9, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30394114/the-need-for-contraception-in-patients-taking-prescription-drugs-a-review-of-fda-warning-labels-duration-of-effects-and-mechanisms-of-action
#2
Zhanhu Zhang, Lili Xu, Zhenyu Zhang, Hongxia Ding, Elizabeth R Rayburn, Haibo Li
This review provides a guide for the rational use of prescription drugs in patients of reproductive age. Areas covered: A comprehensive retrieval of the labels of FDA-approved drugs was performed to identify drugs where the label recommends contraceptive use during and/or after treatment. The acquired data were analyzed and organized into a table. Contraception was recommended or mandated for 268 single-ingredient drugs. These could be divided into four main categories, with many having effects across several categories: 177 drugs required contraception because they were associated with pregnancy loss or stillbirth, 177 drugs were associated with teratogenesis, 136 were associated with non-teratogenic adverse peri- or post-natal effects on the fetus (e...
November 3, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30372367/safety-of-ambroxol-in-the-treatment-of-airway-diseases-in-adult-patients
#3
Dorothea Cazan, Ludger Klimek, Annette Sperl, Manuel Plomer, Thomas Pohlmann, Stephan Kölsch
Ambroxol is a widely used secretolytic and mucoactive over-the-counter agent primarily used to treat respiratory diseases associated with viscid mucus. Following post-marketing reports of hypersensitivity reactions and severe cutaneous adverse reactions (SCARs) possibly linked to ambroxol, the European Union's Pharmacovigilance Risk Assessment Committee (PRAC) initiated in April 2014 a review of the safety of ambroxol in all its registered indications, which was finalized in 2016. Areas covered: Here, we evaluate the clinical safety of ambroxol and provide an expert opinion on the benefit-risk balance of ambroxol in the treatment of adult patients with bronchopulmonary diseases...
October 29, 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30114943/benefit-risk-review-of-different-drug-classes-used-in-chronic-heart-failure
#4
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
https://www.readbyqxmd.com/read/30351243/antimalarial-drugs-for-treating-and-preventing-malaria-in-pregnant-and-lactating-women
#5
Makoto Saito, Mary Ellen Gilder, Rose McGready, François Nosten
Malaria in pregnancy and postpartum cause maternal mortality and adverse fetal outcomes. Efficacious and safe antimalarials are needed to treat and prevent such serious consequences. However, because of the lack of evidence on fetal safety, quinine, an old and less efficacious drug has long been recommended for pregnant women. Uncertainty about safety in relation to breastfeeding leads to withholding of efficacious treatments postpartum or cessation of breastfeeding. Areas covered: A search identified literature on humans in three databases (MEDLINE, Embase and Global health) using pregnancy or lactation, and the names of antimalarial drugs as search terms...
November 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30324820/the-safety-of-apatinib-for-the-treatment-of-gastric-cancer
#6
Ruixuan Geng, Li Song, Jin Li, Lin Zhao
Apatinib is an orally administered small-molecule vascular endothelial growth factor receptor 2 inhibitor. It has been approved and indicated for advanced gastric cancer after the failure of two or more lines of systemic therapy in China. Areas covered: This review summarizes the mechanisms, clinical applications and safety evaluations of apatinib. Apatinib is well tolerated, and its most common adverse effects include hand-foot syndrome, hypertension, proteinuria and neutropenia. Its major grade 3/4 adverse effect is hand-foot syndrome...
November 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30318935/safety-concerns-when-using-novel-medications-to-treat-alopecia
#7
Hind M Almohanna, Marina Perper, Antonella Tosti
Alopecia is often a cause of great concern to patients for cosmetic and psychologic reasons. The aim of treating non-scarring alopecias is to reduce hair loss and, to some extent, enhance hair regrowth. However, therapies for scarring alopecias are limited and aiming to halt disease progression. Nonetheless, available modalities of treatment come with numerous side effects. Areas covered: Many new treatments for non-scarring alopecias have been introduced in recent years. This review summarizes the safety concerns when using novel therapeutic modalities such as JAK inhibitors, hair transplantation, mesotherapy, oral minoxidil, platelet-rich plasma, microneedling, and 5α-reductase inhibitors for treating hair loss...
November 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30286624/the-safety-of-bevazicumab-for-the-treatment-of-ovarian-cancer
#8
Carolina Bottoni, Giovanni Scambia, Anna Fagotti, Marco Petrillo
The safety profile of bevacizumab (BV) remains a challenging issue, in particular its role in fragile OC patients. Areas covered: In this literature review, we have analyzed safety data from Phase III trials evaluating the combination of BV plus standard chemotherapy in advanced or recurrent OC patients. In particular, our review aimed at clarifying the impact of the drug on fragile patients, and the correlation between BV and postoperative complications after cytoreductive surgery. Expert opinion: The addition of BV to standard chemotherapy regimens may cause unexpected side effects such as hypertension or proteinuria in up to 10% of women receiving the drug...
November 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30285501/the-usefulness-of-listening-social-media-for-pharmacovigilance-purposes-a-systematic-review
#9
Irma Convertino, Sara Ferraro, Corrado Blandizzi, Marco Tuccori
Social media mining could be a possible strategy to retrieve drug safety information. The mining of social media is a complex process under progressive evolution, falling into three broad categories: listening (safety data reporting), engaging (follow-up), and broadcasting (risk communication). This systematic review is aimed at evaluating the usefulness and quality of proto-signals by social media listening. Areas covered: In this systematic search, performed according to MOOSE and PRISMA statements, we selected studies, published in MEDLINE, EMBASE, and Google Scholar until 31 December 2017, that listened at least one social media to identify proto-adverse drug events and proto-signals...
November 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30264594/optimal-management-of-patients-with-hepatocellular-carcinoma-treated-with-lenvatinib
#10
Masafumi Ikeda, Masahiro Kobayashi, Makoto Tahara, Shuichi Kaneko
Lenvatinib, a multi-kinase inhibitor, has demonstrated improved outcomes for patients with hepatocellular carcinoma (HCC) in clinical trials. The phase 3 REFLECT trial confirmed the noninferiority of lenvatinib to sorafenib for overall survival of HCC patients and indicated clinical benefits in efficacy over sorafenib. Adverse events (AEs) included hypertension, diarrhea, decreased appetite, decreased weight, fatigue, palmar-plantar erythrodysesthesia, and proteinuria. Areas covered: AEs arising in HCC patients during lenvatinib treatment often lead to treatment interruption, dose reduction, or treatment discontinuation...
November 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30260252/long-term-outcome-in-patients-with-non-valvular-atrial-fibrillation-on-dabigatran-a-prospective-cohort-study
#11
Paolo Verdecchia, Maria Cristina Vedovati, Serenella Conti, Michela Giustozzi, Adolfo Aita, Gabriella Molini, Fabio Angeli, Dario Turturiello, Cecilia Becattini, Claudio Cavallini, Giancarlo Agnelli
Most studies on thromboembolic and bleeding risk in patients with non-valvular atrial fibrillation (NVAF) exposed to non-vitamin K oral anticoagulants stem from interrogation of insurance databases. Areas covered: We studied 742 consecutive patients with NVAF who started treatment with dabigatran in three hospitals in Italy. Average follow-up was 1.80 years. Mean age was 76.2 years. CHA2 DS2 VASc score was 0-1 in 37 (5%), 2 in 97 (13%) and ≥ 3 in 604 (82%) patients. NVAF was permanent in 349 (48%). Overall, 76% of patients remained on treatment over the entire follow-up period...
November 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30252549/analyzing-intent-to-treat-and-per-protocol-effects-on-safety-outcomes-using-a-medical-information-database-an-application-to-the-risk-assessment-of-antibiotic-induced-liver-injury
#12
Yoshinori Takeuchi, Tomohiro Shinozaki, Hiraku Kumamaru, Tatsuo Hiramatsu, Yutaka Matsuyama
OBJECTIVE: To apply a causal analysis approach to estimate the intent-to-treat and per-protocol effects in a safety outcome study of the 30-day risk of liver injury associated with antibiotic use (macrolides, penicillin-based antibiotics, and fluoroquinolones). RESEARCH DESIGN AND METHODS: For each antibiotic class, we constructed a pooled cohort of treated episodes matched with untreated episodes using an electronic medical record database from a university hospital...
November 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30223690/gender-differences-on-benefits-and-risks-associated-with-oral-antithrombotic-medications-for-coronary-artery-disease
#13
REVIEW
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 underrepresented in these clinical trials, most analyses clearly indicate that both men and women may accrue therapeutic benefits from antithrombotic management strategies...
October 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30222469/the-efficacy-and-safety-of-memantine-for-the-treatment-of-alzheimer-s-disease
#14
REVIEW
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...
October 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30222369/drug-induced-bone-loss-a-major-safety-concern-in-europe
#15
REVIEW
Khac-Dung Nguyen, 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: Beyond glucorticoid - the most 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...
October 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30221553/safety-and-efficacy-of-propofol-anesthesia-for-pediatric-target-controlled-infusion-in-children-below-3-years-of-age-a-retrospective-observational-study
#16
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)...
October 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30198799/the-fda-animal-rule-and-its-role-in-protecting-human-safety
#17
Theresa Allio
No abstract text is available yet for this article.
October 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30196729/drugs-that-increase-the-risk-of-community-acquired-pneumonia-a-narrative-review
#18
REVIEW
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...
October 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30193085/moxifloxacin-induced-qt-interval-prolongation-and-torsades-de-pointes-a-narrative-review
#19
REVIEW
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...
October 2018: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/30169997/safety-and-tolerability-profile-of-new-antiepileptic-drug-treatment-in-children-with-epilepsy
#20
REVIEW
Romina Moavero, Laura Rosa Pisani, Francesco Pisani, Paolo Curatolo
Treatment of pediatric 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, hematological parameters, and growth, pubertal, motor, cognitive and behavioral development. Areas covered: Treatment-emergent AEs (TEAEs) reported in the literature 2000-2018 regarding second- and third-generation AEDs used in the pediatric 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...
October 2018: Expert Opinion on Drug Safety
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