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Expert Opinion on Drug Safety

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
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)...
October 18, 2016: Expert Opinion on Drug Safety
Jacques Donnez, Olivier Donnez, Marie-Madeleine Dolmans
During the last decade, there has been increased emphasis on the role of progesterone in the promotion of fibroid growth, as well as heightened interest in modulating progesterone pathways by use of selective progesterone receptor modulators (SPRMs). Among them, ulipristal acetate (UPA) has proved its efficacy in the management of symptomatic myomas by controlling bleeding and inducing amenorrhea, and reducing the size of myomas in the majority of cases. Areas covered: In this review, we summarize published scientific studies exploring evidence of the safety of SPRMs and particularly UPA, a drug approved for the management of symptomatic uterine fibroids...
October 14, 2016: Expert Opinion on Drug Safety
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
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
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
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
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
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
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
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
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
Christian Leporini, Rosanna Piro, Francesco Ursini, Francesca Maida, Caterina Palleria, Franco Arturi, Maria Pavia, Giovambattista De Sarro, Emilio Russo
OBJECTIVE: To compare patients' and physicians' perceptions regarding effectiveness and tolerability of non-insulin hypoglycemic drugs in a cohort of type 2 diabetic patients; to verify whether a possible tridimensional link between effectiveness, tolerability, and adherence affects long-term therapeutic outcomes. METHODS: A two-year observational study was performed in 1389 Type 2 diabetic patients by involving general practitioner clinics and Diabetes Centers...
October 8, 2016: Expert Opinion on Drug Safety
Fabienne A Biétry, Oliver Reich, Matthias Schwenkglenks, Christoph R Meier
OBJECTIVES: Using claims data from the Helsana Group, a large Swiss health insurance provider, we examined the association between statin use and the risk of cholecystectomy in a case-control analysis. METHODS: We identified 2,200 cholecystectomy cases between 2013 and 2014 and matched 4 controls to each case on age, sex, index date and canton. We categorized statin users into current or past users (last prescription ≤ 180 or > 180 days before the index date, respectively) and classified medication use by duration based on number of prescriptions before the index date...
October 6, 2016: Expert Opinion on Drug Safety
Mohamed El Kassas, Tamer Elbaz, Enas Hafez, Gamal Esmat
Hepatitis C virus is a hepatotropic virus that generally leads to chronic hepatitis and various harmful sequelae. The lone standard of treatment has been pegylated interferon and ribavirin, which produces a modest response and many side effects. However, a new era of management was declared with the introduction of various directly acting antiviral agents. Areas covered: Recent direct antiviral agents (DAAs) primarily target the non-structural proteins of the virus and affect its replication. These agents successfully achieve a sustained virologic response...
October 6, 2016: Expert Opinion on Drug Safety
Talla A Rousan, Sunil T Mathew, Udho Thadani
INTRODUCTION: Angina pectoris is a common presenting symptom of underlying coronary artery disease or reduced coronary flow reserve. Patients with angina have impaired quality of life; and need to be treated optimally with antianginal drugs to control symptoms and improve exercise performance. A wide range of antianginal medications are approved for the treatment of angina, and often more than one class of antianginal drugs are used to adequately control the symptoms. This expert opinion highlights the likely cardiac adverse effects of available antianginal drugs, and how to minimize these in individual patients and especially during combination treatment...
September 29, 2016: Expert Opinion on Drug Safety
Puneet Gupta, William B White
Dipeptidyl peptidase-4 (DPP4) inhibitors, glucagon-like peptide-1 (GLP-1) analogs and sodium-glucose cotransporter 2 (SGLT2) inhibitors are relatively new therapies for the treatment of type 2 diabetes mellitus. Given the high prevalence of cardiovascular complications in patients with type 2 diabetes and recent concerns questioning CV safety of newer antidiabetic medications, cardiovascular safety of these medications requires evaluation. Areas covered: Cardiovascular effects of these drug classes from preclinical and clinical data as well as non-cardiovascular safety issues are delineated from literature searches covering the last decade and up to June 2016...
September 21, 2016: Expert Opinion on Drug Safety
Juan Pedro-Botet, Jesús Millán Núñez-Cortés, Juan J Chillarón, Juana A Flores-Le Roux, Joan Rius
OBJECTIVE: To describe the severity of muscle injury (myalgia, myositis and rhabdomyolysis) and associated conditions related to statin therapy that may be clinically significant. RESEARCH DESIGN AND 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. Clinical, biochemical and drug therapy characteristics were obtained at the initial evaluation...
September 20, 2016: Expert Opinion on Drug Safety
Elizabeth E Roughead, Esther W Chan, Nam-Kyong Choi, Jenna Griffiths, Xue-Mei Jin, Joongyub Lee, Michio Kimura, Tomomi Kimura, Kiyoshi Kubota, Edward Chia-Cheng Lai, Kenneth Kc Man, Tuan Anh Nguyen, Nobuhiro Ooba, Byung-Joo Park, Tsugumichi Sato, Ju-Young Shin, TongTong Wang, Ian Ck Wong, Yea-Huei Kao Yang, Nicole L Pratt
OBJECTIVE: To determine the association between incident proton pump inhibitor (PPI) use and Clostridium difficile infections across multiple countries Method: National data covering the total population in Australia and Korea, the Canadian population over 65 years and a 3 million person random sample data set from Taiwan were assessed, as were data from a worker insurance population and a hospital inpatient/outpatient population in Japan. Sequence symmetry analysis was used to assess the association with oral vancomycin dispensing as the outcome of interest...
September 19, 2016: Expert Opinion on Drug Safety
Engi Abdel-Hady Algharably, Iris Filler, Stephanie Rosenfeld, Katja Grabowski, Reinhold Kreutz
Introduction Statin therapy is the backbone of pharmacologic therapy for low-density lipoproteins cholesterol lowering and plays a pivotal role in cardiovascular disease prevention. Statin intolerance is understood as the inability to continue using a statin to reduce individual cardiovascular risk sufficiently, due to the development of symptoms or laboratory abnormalities attributable to the initiation or dose escalation of a statin. Muscle symptoms are the most common side effects observed. Areas covered The main aim of this article is to present a review on published definitions of statin intolerance...
September 19, 2016: Expert Opinion on Drug Safety
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