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Safety and efficacy of denosumab in osteoporotic patients previously treated with other medications: a systematic review and meta-analysis.
Authors: Fontalis A, Eustathios K, Prousali E, Michael P, Eleftherios T Abstract INTRODUCTION: Denosumab is a monoclonal antibody that received approval by the FDA for the treatment of osteoporosis in 2010. Available higher level research evidence concerns the treatment of patients that have not received any anti-osteoporotic medication in the past. Further investigation is warranted, since clinicians often face the challenge of administering the most efficacious drug in patients, pretreated with other medications. Areas Covered: We conducted a systematic review and meta-analysis to evaluate the efficacy and safety...
Source: Expert Opinion on Drug Safety - January 21, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of palbociclib for the treatment of advanced breast cancer.
Authors: Degenhardt T, Wuerstlein R, Eggersmann T, Harbeck N Abstract INTRODUCTION: Despite improvements in the diagnosis and management of early stage breast cancer, about one third of the patients still progress to metastatic disease. Most of the patients with metastatic breast cancer have a hormone receptor positive and human epidermal growth factor receptor 2 negative subtype with a median survival of more than 3 years. For these patients, endocrine therapy with its favorable toxicity profile is the current standard of care. However, patients with metastatic breast cancer have an incurable disease. Therefore, n...
Source: Expert Opinion on Drug Safety - January 19, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

An update on the safety of nutraceuticals and effects on lipid parameters.
Authors: Cicero AFG, Colletti A Abstract INTRODUCTION: Cardiovascular diseases (CVDs) are the leading cause of mortality and disability in developed countries, whereas a large portion of patients in primary prevention have uncontrolled level of CVD risk factors. Dietary supplementation with bioactive natural compounds with demonstrated lipid-lowering effects is currently supported by the international guidelines for CVD prevention and some international expert panels. Areas covered: This review provides insights on issues concerning the tolerability and safety of the most commonly used nutraceuticals with demonstra...
Source: Expert Opinion on Drug Safety - January 19, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of available treatments of male hypogonadism in organic and functional hypogonadism.
Authors: Corona G, Rastrelli G, Reisman Y, Sforza A, Maggi M Abstract INTRODUCTION: In the case of primary male hypogonadism (HG), only testosterone (T) replacement therapy (TRT) is possible whereas when the problem is secondary to a pituitary or hypothalamus alteration both T production and fertility can be, theoretically, restored. We here systematically reviewed and discussed the advantages and limits of medications formally approved for the treatment of HG. Areas covered: Data derived from available meta-analyses of placebo controlled randomized trials (RCTs) were considered and analyzed. Gonadotropins are well...
Source: Expert Opinion on Drug Safety - January 16, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A Comparative Safety Review between GLP-1 Receptor Agonists and SGLT2 Inhibitors for Diabetes Treatment.
Authors: Consoli A, Formoso G, Baldassarre MPA, Febo F Abstract INTRODUCTION: Glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium glucose cotransporter 2 inhibitors (SGLT2i) are of particular interest in type 2 diabetes treatment strategies, due to their efficacy in reducing HbA1c with a low risk of hypoglycaemia, to their positive effects on body weight and blood pressure and in light of their effects on cardiovascular risk and on nephroprotection emerged from the most recent cardiovascular outcome trials. Since it is therefore very likely that GLP-1RA and SGLT2i use will become more and more common, it...
Source: Expert Opinion on Drug Safety - January 16, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The cardiovascular effect of incretin-based therapies among type 2 diabetes: a systematic review and network meta-analysis.
CONCLUSIONS: Incretin-based therapies show similar cardiovascular risk in comparison with metformin, insulin, thiazolidinediones, alpha-glucosidase inhibitor and sodium-glucose co-transporter 2. GLP-1RA could decrease the risk compared with sulfonylurea or placebo, while DPP-4I appears to have neutral effect on cardiovascular risk. PMID: 29320889 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - January 13, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Twelve weeks of ombitasvir/paritaprevir/r and dasabuvir without ribavirin is effective and safe in the treatment of patients with HCV genotype 1b infection and compensated cirrhosis: results from a real-world cohort study.
CONCLUSIONS: The simplified regimen of OBV/PTV/r+DSV administered for 12 weeks is effective and safe in patients with chronic HCV genotype 1b infection and compensated cirrhosis. No adverse reactions related to drug-drug interactions were recorded. PMID: 29325476 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - January 13, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The role of Iloprost on bone oedema and osteonecrosis: Review of current evidence.
Authors: Pountos I, Giannoudis PV Abstract INTRODUCTION: Iloprost is a commercially available prostaglandin I2 (PGI2) analogue that is shown to have antithrombotic, vasodilatative and antiproliferative effects. A number of clinical studies have shown that Iloprost can be effective in the management of bone marrow oedema and the treatment of avascular necrosis. The aim of this manuscript is to present our current understanding on the effect of Iloprost on the treatment of these conditions. Areas covered: The authors offer a comprehensive review of the existing literature on the experimental and clinical studies anal...
Source: Expert Opinion on Drug Safety - January 11, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Effects of interdisciplinary collaboration in hospitals on medication errors: an integrative review.
Authors: Manias E Abstract INTRODUCTION: Medication errors are commonly affected by breakdowns in communication. Interdisciplinary collaboration is an important means of facilitating communication between health professionals in clinical practice. To date, there has been little systematic examination of past research in this area. Areas covered: The aims of this integrative review are to examine how interdisciplinary collaboration influences medication errors in hospitals, the araes of interdisciplinary collaboration that have been researched in previous work, and recommendations for future research and practice. A...
Source: Expert Opinion on Drug Safety - January 6, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Preventable ADRs leading to hospitalization - results of a long-term prospective safety study with 6,427 ADR cases focusing on elderly patients.
CONCLUSION: Avoiding PIM usage seems to be of limited value in increasing safety in elderly patients whereas our results underline the importance of an individualized medication review of the most commonly implicated drugs in preventable ADRs (supported by BfArM FoNr: V-11337/68605/2008-2010). PMID: 29258401 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - December 22, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

New and Incremental FDA Black Box Warnings from 2008 to 2015.
CONCLUSIONS: New BBWs and incremental updates to existing BBWs are frequently added to drug labels after regulatory approval. PMID: 29215916 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - December 9, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Therapeutic drug monitoring of anti-TNF therapy in children with inflammatory bowel disease.
Authors: van Hoeve K, Hoffman I, Vermeire S Abstract INTRODUCTION: Although anti-TNF therapy has changed the scenery of pediatric inflammatory bowel diseases (IBD) immensely, there are still patients with an unfortunate outcome. Approximately one third of patients that initially respond to anti-TNF therapy will lose that response over time and need treatment optimization. Loss of response (LOR) is a big concern in IBD management and especially among pediatric patients where treatment options are more limited than in adults. In children it is even more important to sustain response with minimal toxicity. Therapeutic...
Source: Expert Opinion on Drug Safety - December 7, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety evaluation of raltegravir for the treatment of HIV.
Authors: de Miguel R, Montejano R, Stella-Ascariz N, Arribas JR Abstract INTRODUCTION: Raltegravir (RAL) was the first commercialized agent from a new drug class with an innovative target, the integrase. Since its introduction in clinical practice RAL has become widely used for the treatment of HIV-1 infected patients. A decade after its approval, this article reviews key evidence from RAL with a special interest on safety outcomes. Areas covered: Pharmacologic, safety and efficacy data of RAL from clinical trials and post-commercialization published reports are hereby summarized after a literature review including...
Source: Expert Opinion on Drug Safety - December 6, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety review of the medications used to treat atopic dermatitis.
Authors: Shukla S, Feldman SR, Strowd LC Abstract INTRODUCTION: Atopic dermatitis (AD) is a common disease in children and adults which causes severe physical discomfort and psychosocial distress. Recently novel therapies for AD have been FDA approved for use which creates the need to review the safety surrounding current FDA approved AD medications. Areas covered: Published clinical studies involving topical and oral FDA approved medications for AD are included in this review. Authors used PubMed research database to search for clinical trials involving AD patients. Expert opinion: AD is a common disease which cur...
Source: Expert Opinion on Drug Safety - December 4, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

First experiences with a tool to measure the level of clinical information present in adverse drug reaction reports.
CONCLUSION: This is the first tool to give insight in the level of relevant clinical information present in ADR reports. It can be used internationally to compare reports coming from different reporting methods and different types of reporters in pharmacovigilance. PMID: 29157026 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 23, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Things fall apart with hepatocellular carcinoma and direct-acting antivirals.
Authors: Kutala B, Valla D, Marcellin P PMID: 29137488 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 17, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety review of medications used for labour induction.
This article reviews the safety of currently used induction agents. Prostaglandins and oxytocin have proven to be effective in labour induction, and their profiles will be reviewed in this article. We discuss the data that supports combining some of the agents. We also cover the safety of medications used for labour induction in setting of a scarred uterus. Expert Opinion: There is continuous debate about the ideal induction agent: one that balances safety with efficacy. We recommend the practice that there is not one perfect agent for all, and that the clinical scenario and previous obstetric history should be considered ...
Source: Expert Opinion on Drug Safety - November 17, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Alcohol addiction - the safety of available approved treatment options.
Authors: Antonelli M, Ferrulli A, Sestito L, Vassallo GA, Tarli C, Mosoni C, Rando MM, Mirijello A, Gasbarrini A, Addolorato G Abstract INTRODUCTION: Alcohol Use Disorder (AUD) is a leading cause of mortality and morbidity worldwide. At present disulfiram, naltrexone and acamprosate are approved for the treatment of AUD in U.S. and Europe. Nalmefene is approved in Europe and sodium oxybate is approved in Italy and Austria only. Baclofen received a "temporary recommendation for use" in France. Areas covered. The safety of the medications mentioned above on liver, digestive system, kidney function, nervous ...
Source: Expert Opinion on Drug Safety - November 10, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Efficacy and safety of a combination of HER2-targeted agents as first-line treatment for metastatic HER2-positive breast cancer: a network meta-analysis.
CONCLUSIONS: TDPs are a preferred first-line treatment for HER2-positive metastatic breast cancer compared with other target agent regimens. PMID: 29108432 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 9, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Skin cancer associated with commonly prescribed drugs: tumor necrosis factor alpha inhibitors (TNF- αIs), angiotensin-receptor blockers (ARBs), phosphodiesterase type 5 inhibitors (PDE5Is) and statins -weighing the evidence.
Skin cancer associated with commonly prescribed drugs: tumor necrosis factor alpha inhibitors (TNF-αIs), angiotensin-receptor blockers (ARBs), phosphodiesterase type 5 inhibitors (PDE5Is) and statins -weighing the evidence. Expert Opin Drug Saf. 2017 Nov 06;: Authors: Nardone B, Orrell KA, Vakharia PP, West DP Abstract INTRODUCTION: Skin cancers, including both malignant melanoma (MM) and nonmelanoma skin cancer (NMSC), are the most commonly diagnosed cancers in the US. The incidence of both MM and NMSC continues to rise. Areas Covered: Current evidence for an association between four of the most...
Source: Expert Opinion on Drug Safety - November 7, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of available treatment options for iron-deficiency anemia.
Authors: Muñoz M, Gómez-Ramírez S, Bhandari S Abstract INTRODUCTION: Iron deficiency (ID), with or without anemia, is highly prevalent worldwide and has clinical consequences. The prevention and treatment of ID is a major public health goal. Accurate diagnosis, selection of the appropriate iron replacement therapy and addressing the underlying cause, remain as the main challenges in ID management. Areas covered. This review aims to provide a narrative review of current available evidence on iron supplementation options regularly used to treat ID, including oral and intravenous (IV) iron formula...
Source: Expert Opinion on Drug Safety - November 7, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Drug-Drug Interactions as a Result of Co-Administering Δ(9)-THC and CBD with Other Psychotropic Agents.
Drug-Drug Interactions as a Result of Co-Administering Δ(9)-THC and CBD with Other Psychotropic Agents. Expert Opin Drug Saf. 2017 Oct 30;: Authors: Rong C, Carmona NE, Lee YL, Ragguett RM, Pan Z, Rosenblat JD, Subramaniapillai M, Shekotikhina M, Almatham F, Alageel A, Mansur R, Ho RC, McIntyre RS Abstract INTRODUCTION: To determine, via narrative, non-systematic review of pre-clinical and clinical studies, whether the effect of cannabis on hepatic biotransformation pathways would be predicted to result in clinically significant drug-drug interactions (DDIs) with commonly prescribed psychotropic ...
Source: Expert Opinion on Drug Safety - October 31, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The Safety of Treatments Used in Pyoderma Gangrenosum.
Authors: Feldman SR, Lacy FA, Huang WW Abstract INTRODUCTION: Pyoderma gangrenosum (PG) is a severe ulcerating orphan dermatosis characterized by painful and rapidly progressive skin ulcers often associated with underlying inflammatory disease. Areas covered: In this article, we review and analyze the literature regarding treatment options for patients with PG, with particular attention to the efficacy and safety of therapies. Despite the significance of this problem, there are few studies devoted to the efficacy or safety of therapeutics in PG. We aim to present and evaluate existing studies and reports, and to ma...
Source: Expert Opinion on Drug Safety - October 28, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Perindopril Arginine and Amlodipine Besylate for Hypertension: A Safety Evaluation.
Authors: Elliott WJ, Bistrika EA Abstract INTRODUCTION: Controlling blood pressure is a global health priority; single-pill antihypertensive combinations may improve adherence, persistence, and outcomes. Areas Covered: A novel combination of perindopril arginine and amlodipine besylate was recently approved. A systematic review of the literature revealed its most common adverse effects as: peripheral edema (depending on the dose of amlodipine, but attenuated by perindopril), cough, dizziness and hypotension. Dose-dependent hyperkalemia, impairment of renal function (especially in renovascular hypertension), angioed...
Source: Expert Opinion on Drug Safety - October 28, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A narrative review of the safety concerns of deprescribing in older adults and strategies to mitigate potential harms.
Authors: Reeve E, Moriarty F, Nahas R, Turner JP, Kouladjian O'Donnell L, Hilmer SN Abstract INTRODUCTION: As with prescribing or continuing medications, deprescribing brings with it the potential for harm as well as benefit. Uncertainty and avoidance of harm has been reported as a barrier to deprescribing in practice and may contribute to continuation of inappropriate medications. Areas covered: This narrative review covers four main safety concerns/potential harms of deprescribing in older adults: adverse drug withdrawal events, return of medical condition(s), reversal of drug-drug interactions and damage to the ...
Source: Expert Opinion on Drug Safety - October 28, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Post-marketing withdrawal of analgesic medications because of adverse drug reactions: a systematic review.
Authors: Onakpoya IJ, Heneghan CJ, Aronson JK Abstract INTRODUCTION: Many analgesics have been withdrawn from the market because of adverse drug reactions. Controversy still surrounds the use of some approved analgesics for pain management. However, the trends and reasons for withdrawal of analgesics when harms are attributed to their use have not been systematically assessed. Areas covered: We conducted searches in PubMed; Embase; Google Scholar; clinicaltrials.gov; WHO databases of withdrawn products; websites of the European Medicines Agency, the US Food and Drug Administration, the UK Medicines and Healthcare p...
Source: Expert Opinion on Drug Safety - October 28, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Statin drug interactions and related adverse reactions: an update.
Authors: Bellosta S, Corsini A Abstract INTRODUCTION: Statins reduce the risk of cardiovascular morbidity and mortality in patients with or at risk for cardiovascular disease and their use is expanding, especially in elderly. Statins are prescribed on a long-term basis and may undergo drug-drug interactions (DDIs) with other drugs. Statins have different safety and tolerability, and this might affect the possibility of DDIs with other cardiovascular drugs, increasing the risk of statin-associated myopathy and hepatotoxicity. Polypharmacy and pharmacogenetic variability are potential causes of statin DDIs. Thus, the...
Source: Expert Opinion on Drug Safety - October 24, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Corrigendum.
Authors: PMID: 29046068 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - October 21, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety and efficacy of dabrafenib and trametinib for the treatment of melanoma.
Authors: Knispel S, Zimmer L, Kanaki T, Ugurel S, Schadendorf D, Livingstone E Abstract INTRODUCTION: The introduction of BRAF and MEK inhibitors into clinical practice improved the prognosis of metastatic melanoma patients. The combination of BRAF inhibitor dabrafenib with MEK inhibitor trametinib has shown its superiority to single agent therapy and is characterized by a tolerable spectrum of adverse events which shows a decrease in incidence over time on treatment. Areas covered: The current scientific literature on safety and adverse events (AEs) related to BRAF and MEK-inhibition has been investigated with spe...
Source: Expert Opinion on Drug Safety - October 21, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety of pharmacotherapy options for bulimia nervosa and binge eating disorder.
Authors: Bello NT, Yeomans BL Abstract INTRODUCTION: Eating disorders represent a set of psychiatric illnesses with lifelong complications and high relapse rates. Individuals with eating disorders are often stigmatized and clinicians have a limited set of treatments options. Pharmacotherapy has the potential to improve long term compliance and patient commitment to treatment for eating disorders. Areas Covered: This review will examine the efficacy and safety profile of the FDA-approved medications for the treatment of bulimia nervosa (BN) and binge eating disorder (BED). This will include the evaluation of fluoxet...
Source: Expert Opinion on Drug Safety - October 21, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Psychotropic drugs and CYP2D6 in late-life psychiatric and neurological disorders. What do we know?
Authors: Seripa D, Lozupone M, Stella E, Paroni G, Bisceglia P, La Montagna M, D'onofrio G, Gravina C, Urbano M, Priore MG, Lamanna A, Daniele A, Bellomo A, Logroscino G, Greco A, Panza F Abstract INTRODUCTION: Late-life psychiatric and neurological disorders (LLPND) are interesting models to understand the potential role of pharmacogenetics in drug management, since several pharmacological approaches for treating LLPND have proven to be ineffective or deleterious, thus resulting in therapeutic failures (TF) and adverse drug reactions (ADR). Common variants in the genes encoding the cytochrome P450 (CYP) enzyme sys...
Source: Expert Opinion on Drug Safety - October 16, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Biologics in pediatric psoriasis - efficacy and safety.
Authors: Dogra S, Mahajan R Abstract Introduction Childhood psoriasis is a special situation that is a management challenge for the treating dermatologist. As is the situation with traditional systemic agents, which are commonly used in managing severe psoriasis in children, the biologics are being increasingly used in the recalcitrant disease despite limited data on long term safety. Areas covered - We performed an extensive literature search to collect evidence-based data on the use of biologics in pediatric psoriasis. The relevant literature published from 2000 to September 2017 was obtained from PubMed, using t...
Source: Expert Opinion on Drug Safety - October 14, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A Safety Evaluation of Evolocumab.
Authors: Roth EM Abstract INTRODUCTION: Evolocumab is an injectable, fully human monoclonal antibody and a member of the newest class of low density lipoprotein cholesterol (LDL-C) lowering agents called proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. The PCSK9 inhibitors are the most significant advance in lipid therapy since the introduction of the first statin 30 years ago. Areas covered: The PCSK9 monoclonal antibodies have demonstrated a consistently high LDL-C lowering efficacy with and without statins and/or other lipid lowering therapies (LLT). LDL-C levels achieved with these agents are l...
Source: Expert Opinion on Drug Safety - October 11, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety of hormonal contraception for obese women.
Authors: Rocha ALL, Campos RR, Miranda MMS, Raspante LBP, Carneiro MM, Vieira CS, Reis FM Abstract INTRODUCTION: Obese women have special safety requirements for contraceptive choice, but the evidence supporting such decision is dispersed and sometimes conflicting. Despite being effective, well tolerated and safe for most women, hormonal contraceptives are underused by obese women due to fear of contraceptive failure, weight gain and venous thrombosis. Areas covered: We performed a comprehensive literature search to identify studies about hormonal contraception in overweight and obese women, including safety concer...
Source: Expert Opinion on Drug Safety - October 11, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A review of clinical safety data for sumatriptan nasal powder administered by a breath powered exhalation delivery system in the acute treatment of migraine.
Authors: Silberstein SD Abstract Introduction AVP-825 (sumatriptan nasal powder) is an FDA-approved intranasal medication delivery system containing low-dose sumatriptan powder for acute treatment of migraine with or without aura in adults. AVP-825 utilizes unique nasal anatomy features to avoid limitations of other intranasal delivery methods. Areas covered Literature search terms: "AVP-825", "sumatriptan nasal powder", "intranasal sumatriptan", "sumatriptan safety", "sumatriptan acute migraine". Pharmacokinetic, Phase 2/3 studies, reviews (AVP-825) and metanalyses...
Source: Expert Opinion on Drug Safety - October 11, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Pediatric pharmacoepidemiology - Safety and effectiveness of medicines for ADHD.
Authors: Clavenna A, Bonati M Abstract INTRODUCTION: Attention-deficit hyperactivity disorder (ADHD) is a common neurobehavioral disorder in children and adolescents that comprises core symptoms of developmentally inappropriate levels of inattention and/or hyperactivity and impulsivity. Stimulant (methylphenidate, amphetamines) and non stimulant (atomoxetine, clonidine and guanfacine) are the treatment usually prescribed for ADHD. Area covered: This review covers the safety of ADHD medications in children and adolescents. MEDLINE, EMBASE and PsycINFO databases were searched with the aim to retrieve prospective stud...
Source: Expert Opinion on Drug Safety - October 7, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Policies to Mitigate Nonmedical Use of Prescription Medications: How Should Emerging Evidence of Gabapentin Misuse Be Addressed?
Authors: Peckham AM, Fairman KA, Sclar DA Abstract INTRODUCTION: Over the past decade, increased prescription supply has facilitated an epidemic of nonmedical use of controlled substances, including predominantly opioids, as well as benzodiazepines, z-hypnotics, and stimulants. Areas covered: More recently, misuse of noncontrolled prescriptions, such as gabapentin, has been detected. Gabapentin misuse has been associated with drug-related harm and increased healthcare service utilization in a few studies, including a recent large-sample analysis of commercially insured enrollees in the United States (U.S.) Respondi...
Source: Expert Opinion on Drug Safety - October 7, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Drugs approved for the treatment of Multiple Sclerosis: review of their safety profile.
Authors: Auricchio F, Scavone C, Cimmaruta D, di Mauro G, Capuano A, Sportiello L, Rafaniello C Abstract INTRODUCTION: Multiple sclerosis (MS) is a chronic immune-mediated inflammatory disorder of the brain and spinal cord characterized by inflammation, demyelination, and axonal degeneration. Area covered: Even though the pharmacological armamentarium for MS treatment is considerably improved in the last 20 years, safety data especially for the second-line and innovative treatments are lacking. In order to analyze the safety profile of drugs used for the treatment of MS, a literature review of pre-marketing, post-m...
Source: Expert Opinion on Drug Safety - October 6, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Efficacy and Safety of Dronedarone in the Treatment of Patients with Atrial Fibrillation.
Authors: Khan MH, Rochlani Y, Aronow WS Abstract INTRODUCTION: Dronedarone, a derivative of amiodarone with structural modifications, was designed to have similar electrophysiological properties with a less toxic profile. Areas covered: Brief overview of the pharmacology of dronedarone followed by a summary of randomized clinical trials testing the efficacy of dronedarone in maintaining normal sinus rhythm and clinical outcomes associated with these trials. In depth discussion and commentary on trial findings which may seem contradictory at first approach and brief discussion of post-marketing surveillance studies....
Source: Expert Opinion on Drug Safety - October 1, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Fetal programming of mental health by acetaminophen? Response to the SMFM Statement: Prenatal Acetaminophen Use and ADHD.
Authors: Olsen J, Liew Z Abstract INTRODUCTION: A number of studies indicate that acetaminophen taken during pregnancy may have a programming effect on the fetal brain development. The potential adverse consequences may only surface to clinical detection years later. Should we act on these findings now or do we wait for additional evidence? Areas covered: We argue for action inspired by these well analyzed studies that are based on five prospective cohorts data collected from different countries. Several analytical options have been employed especially to address confounding, and all analyses have consistently sugg...
Source: Expert Opinion on Drug Safety - September 27, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Cardiovascular effects of methadone and concomitant use of diazepam during methadone maintenance treatment induction: low concentration risk.
Conclusions The prolongation of QTc below the risk threshold in low methadone therapeutic doses has been recorded and concomitant use of diazepam could be a co-factor in such issue. PMID: 28934555 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 23, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety evaluation of empagliflozin plus linagliptin for treating type 2 diabetes.
Authors: Gallwitz B Abstract INTRODUCTION: Dipeptidyl-peptidase-IV inhibitors (DPP-4i) and sodium-glucose-transporter-2 inhibitors (SGLT-2i) are oral antidiabetic drugs that improve glycemic parameters and possess a very low intrinsic hypoglycemia risk and favorable cardiovascular data. Areas covered: An overview on the clinical studies investigating the combination therapy with the DPP-4i linagliptin and the SGLT-2i empagliflozin is given. The clinical evidence for the efficacy and safety of free combinations as well as for their fixed dose combinations is presented. Empagliflozin has recently proved to reduce car...
Source: Expert Opinion on Drug Safety - September 23, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

High-dose interleukin-2 (IL-2) for the treatment of melanoma: Safety considerations and future directions.
Authors: Marabondo S, Kaufman HL Abstract INTRODUCTION: In 1998, high-dose interleukin-2 (IL-2) was the first immunotherapy approved for the treatment of metastatic melanoma based on durable objective responses documented in a subset of patients but widespread utilization was limited by significant toxicity. Advances in targeted therapy and the emergence of T cell checkpoint inhibitors, which can generally be given in the ambulatory setting, have further limited consideration of IL-2 for melanoma patients and the role of IL-2 in the current landscape of melanoma treatment is uncertain. Areas covered: In this review...
Source: Expert Opinion on Drug Safety - September 21, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Recommendations on managing lenvatinib and everolimus in patients with advanced or metastatic renal cell carcinoma.
Authors: Grande E, Glen H, Aller J, Argenziano G, Lamas MJ, Ruszniewski P, Zamorano JL, Edmonds K, Sarker S, Staehler M, Larkin J Abstract INTRODUCTION: There are several second-line treatment options for patients with renal cell carcinoma after first-line failure of a tyrosine kinase inhibitor, especially with the recent approvals of cabozantinib, nivolumab, and the lenvatinib plus everolimus combination. A lack of reliable biomarkers and an overall lack of prospective head-to-head comparisons make it a challenge to choose a second-line treatment in the clinic. Areas covered: In this review/meta-opinion, we descri...
Source: Expert Opinion on Drug Safety - September 20, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Lurasidone: Efficacy and Safety in the Treatment of Psychotic and Mood Disorders.
Authors: Pompili M, Verzura C, Trovini G, Buscajoni A, Falcone G, Naim S, Nardella A, Sorice S, Baldessarini RJ, Girardi P Abstract INTRODUCTION: Lurasidone ([3aR,4S,7R,7aS]-2-[(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1yl-methyl] cyclohexylmethyl]-hexahydro-4,7-methano-2H-isoindole-1,3-dione hydrochloride; Latuda® [LRSD]) is a novel benzisothiazole, second-generation antipsychotic drug developed by Dainippon Sumitomo Pharma Corporation in Japan. Similar to other atypical antipsychotics it has a distinctive pharmacodynamic profile, Areas covered: This review updates reported research findings on the effic...
Source: Expert Opinion on Drug Safety - September 14, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety issues associated with using medication to treat overactive bladder.
Authors: Araklitis G, Cardozo L Abstract INTRODUCTION: The mainstay of overactive bladder treatment is the use of anticholinergic medication with its common side effects well known. This review focused on three less well-known safety issues when treating OAB. Areas covered: Patients with increased anticholinergic load are at risk of cognitive decline, dementia or even death. The elderly are particularly at risk due to polypharmacy. Botulinum toxin carries the risk of high urinary residuals, urinary tract infection and need to self catheterise. The use of vaginal oestrogens may improve OAB symptoms, but there is con...
Source: Expert Opinion on Drug Safety - September 13, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Non-chemotherapy drug-induced neutropenia - an update.
Authors: Andrès E, Mourot-Cottet R Abstract INTRODUCTION: To date, non-chemotherapy drug-induced severe neutropenia (neutrophil count of ≤0.5 x 10(9)/L) also called idiosyncratic drug-induced agranulocytosis is little discussed in the literature. In the present paper, we report and discuss the clinical data and management of this rare disorder. Areas covered: To do this, we carried out a review of the literature using PubMed database of the US National Library of Medicine. We also used data from the American Society of Hematology educational books, textbooks of Hematology and Internal medicine, and inform...
Source: Expert Opinion on Drug Safety - September 8, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Unspecified Intestinal Malabsorption in patients treated with Angiotensin-Converting Enzyme Inhibitors or Angiotensin Receptor Blockers: a Retrospective Analysis in Primary Care Settings.
CONCLUSIONS: this study indicates that ACE-i or ARBs were rarely associated to an unspecified IM diagnosis. No relevant difference between each specific ACE-i and ARB was highlighted. PMID: 28871813 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 7, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of edoxaban for treating atrial fibrillation.
Authors: Hammwoehner M, Goette A Abstract INTRODUCTION: Atrial Fibrillation (AF) has a worldwide increasing incidence and prevalence, putting patients at risk for atrial thrombus formation and consecutive thromboembolic events. Morbidity and mortality have become a significant global public health care burden. Thus, there is increasing need for safe and effective medical prophylaxis of thromboembolic events. Edoxaban is the fourth approved non-vitamin K oral anticoagulant (NOAC) that has been introduced into the market for the prophylaxis of stroke or systemic embolism in non valvulär AF patients after dabigat...
Source: Expert Opinion on Drug Safety - September 3, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Corrigendum.
Authors: PMID: 28854830 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 1, 2017 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research