1,715 results match your criteria Expert Opinion on Drug Safety[Journal]


Pediatric drug safety signal detection of non-chemotherapy drug-induced neutropenia and agranulocytosis using electronic healthcare records.

Expert Opin Drug Saf 2019 Apr 19:1-7. Epub 2019 Apr 19.

a Clinical Research Center , National Center for Children's Health, Beijing Children's Hospital, Capital Medical University , Beijing , China.

Objectives: This study aimed to develop a procedure to explore the adverse drug reaction signals of drug-induced neutropenia (DIN) or drug-induced agranulocytosis (DIA) in children using an electronic health records (EHRs) database.

Methods: A two-stage design was presented. First, the suspected drugs to induce DIN or DIA were selected. Read More

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http://dx.doi.org/10.1080/14740338.2019.1604682DOI Listing

An update on heart disease risk associated with testosterone boosting medications.

Expert Opin Drug Saf 2019 Apr 18. Epub 2019 Apr 18.

b Andrology, Female Endocrinology and Gender Incongruence Unit, Department of Experimental, Clinical and Biomedical Sciences , University of Florence , Florence , Italy.

Introduction: The cardiovascular (CV) safety of testosterone replacement therapy (TRT) remains a crucial issue in the management of subjects with late onset hypogonadism. The authors systematically reviewed and discussed the available evidence focusing our analysis on heart related issues. Areas covered: All the available data from prospective observational studies evaluating the role endogenous T levels on the risk of acute myocardial infarction (AMI) were collected and analyzed. Read More

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http://dx.doi.org/10.1080/14740338.2019.1607290DOI Listing

Are biological drugs effective and safe in older severe asthmatics?

Expert Opin Drug Saf 2019 Apr 13. Epub 2019 Apr 13.

a Biomedical Department of Internal Medicine and Medical Specialties (DIBIMIS) , University of Palermo , 90127 Palermo , Italy.

Introduction: The treatment of asthma in the most advanced ages follows the recommendations of international guidelines for the management of asthma in younger ages, although older age has always represented an exclusion criterion for eligibility to pharmacological trials. This poses a clinical challenge when deciding whether elderly severe asthmatics are candidates for biological drugs. Areas covered: The current article has a narrative structure to review current literature on efficacy and safety of novel pharmacological drugs against immunoglobulins and interleukins that mediate and orchestrate the main inflammatory pathways in severe asthma, in order to explore whether older subjects (i. Read More

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https://www.tandfonline.com/doi/full/10.1080/14740338.2019.1
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http://dx.doi.org/10.1080/14740338.2019.1607838DOI Listing
April 2019
2 Reads

Update on BRAF and MEK inhibition for treatment of melanoma in metastatic, unresectable, and adjuvant settings.

Expert Opin Drug Saf 2019 Apr 12:1-12. Epub 2019 Apr 12.

a Department of Cutaneous Oncology , Moffitt Cancer Center , Tampa , FL , USA.

Introduction: Selective inhibition of the MAPK pathway with BRAF and MEK inhibitors has emerged as a key component of the treatment of BRAF-mutant unresectable/locally advanced metastatic melanoma. Areas covered: Current data are presented on the efficacy and safety of BRAFi + MEKi combination therapy (dabrafenib/trametinib, vemurafenib/cobimetinib, and encorafenib/binimetinib) from phase I, II, and III trials in the unresectable/locally advanced metastatic setting, as well as neoadjuvant and adjuvant applications. The theoretical basis, pre-clinical findings, clinical trial results and current ongoing clinical studies of combined BRAF/MEK inhibition with immunotherapy, also known as 'triplet therapy,' are also explored. Read More

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http://dx.doi.org/10.1080/14740338.2019.1607289DOI Listing

Review of the long-term safety of lomitapide: a microsomal triglycerides transfer protein inhibitor for treating homozygous familial hypercholesterolemia.

Expert Opin Drug Saf 2019 Apr 4. Epub 2019 Apr 4.

a Clinical Lipidology and Rare Lipid Disorders Unit, Community Genomic Medicine Center, Department of Medicine , Université de Montréal and ECOGENE-21 Clinical and Translational Research Center , Chicoutimi , Québec , Canada.

Introduction: Homozygous familial hypercholesterolemia (HoFH) is a rare and life-threatening lipid disorder characterized by extremely elevated low-density lipoprotein-cholesterol (LDL-C) concentrations and premature atherosclerotic cardiovascular disease (CVD). Conventional lipid-lowering agents remain insufficient in managing this disease, which emphasize the unmet medical need for potential therapies capable of lowering LDL-C and decreasing CVD risk in this patient population. Areas covered: Novel LDL receptor (LDLR) independent drugs have been recently approved or are in development for the treatment of HoFH, including lomitapide (Juxtapid®). Read More

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http://dx.doi.org/10.1080/14740338.2019.1602606DOI Listing
April 2019
2 Reads

The safety of treating newly diagnosed epilepsy.

Expert Opin Drug Saf 2019 Apr 4:1-11. Epub 2019 Apr 4.

a Department of Neuroscience , Central Clinical School, Monash University , Melbourne , Australia.

Introduction: Epilepsy is a serious chronic neurological disorder manifested by an enduring symptomatic predisposition to seizures. Newly diagnosed individuals face increased morbidity, mortality, and socioeconomic costs. Anti-epileptic drug therapy is the treatment usually prescribed, which has efficacy in seizure control and mitigating long-term mortality. Read More

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http://dx.doi.org/10.1080/14740338.2019.1602607DOI Listing
April 2019
2 Reads

Immunogenicity of infliximab and adalimumab.

Expert Opin Drug Saf 2019 Apr 2:1-3. Epub 2019 Apr 2.

a Clinical Immunology Unit, Department of Internal Medicine , University of Genoa and Ospedale Policlinico San Martino , Genoa , Italy.

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http://dx.doi.org/10.1080/14740338.2019.1602117DOI Listing
April 2019
1 Read

An update on the safety of SGLT2 inhibitors.

Authors:
André J Scheen

Expert Opin Drug Saf 2019 Apr 1:1-17. Epub 2019 Apr 1.

a Division of Clinical Pharmacology , Center for Interdisciplinary Research on Medicines (CIRM), Liège University , Liège , Belgium.

Introduction: Sodium-glucose cotransporter type 2 inhibitors (SGLT2is) are recommended after metformin for a large spectrum of patients with type 2 diabetes, because of a favorable benefit/risk profile despite a variety of adverse events. Areas covered: This narrative review discusses the safety profile of SGLT2is: initial concerns (cardiovascular safety, acute renal failure, hypoglycemia, urinary and genital infections, volume depletion, bladder cancer), further concerns (euglycemic ketoacidosis, bone fractures) and more recent concerns (lower limb amputation, Fournier's gangrene). Expert opinion: Overall, the safety profile of SGLT2is is good. Read More

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http://dx.doi.org/10.1080/14740338.2019.1602116DOI Listing
April 2019
2 Reads

Potentially inappropriate concomitant medicine use with the selective COX-2 inhibitor celecoxib: Analysis and comparison of spontaneous adverse event reports from Australia, Canada and the USA.

Expert Opin Drug Saf 2019 Mar;18(3):153-161

a Discipline of Pharmacy, School of Health and Biomedical Sciences , RMIT University , Bundoora , Australia.

Background: To perform an international comparison and analysis of celecoxib spontaneous adverse event reports (AERs) from Canada, Australia and the United States, focusing on gastrointestinal, renal and cardiovascular events. This study also examined concomitant medicines use which may have potentiated the risk of the reported adverse events. Research, design and methods: Three databases were searched for spontaneous AERs associated with celecoxib, submitted within the past 10 years: Australian Therapeutic Goods Administration Database of Adverse Event Notifications; Canada Vigilance Adverse Reaction Online Database; and the United States Food and Drug Administration Adverse Event Reporting System Database. Read More

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http://dx.doi.org/10.1080/14740338.2019.1589447DOI Listing
March 2019
1 Read

Efficacy and safety of Xa inhibitors for the treatment of cancer-associated venous thromboembolism.

Expert Opin Drug Saf 2019 Mar 29:1-8. Epub 2019 Mar 29.

a Department of Medicine , University of Ottawa, and the Ottawa Hospital Research Institute , Ottawa , Canada.

Introduction: Cancer patients with cancer-associated thrombosis (CAT) are at an elevated risk of recurrent venous thromboembolism (VTE) and of major bleeding while receiving treatment with anticoagulation. Recently, Xa inhibitors have been assessed in cancer patients for the treatment of CAT, providing clinicians and patients with more treatment options. Areas covered: In this narrative review, the authors evaluate the evidence regarding the efficacy and safety of edoxaban, rivaroxaban, and apixaban in the treatment of CAT. Read More

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http://dx.doi.org/10.1080/14740338.2019.1601699DOI Listing
March 2019
1 Read

Safety and tolerability of available urate-lowering drugs: a critical review.

Expert Opin Drug Saf 2019 Mar 27:1-11. Epub 2019 Mar 27.

b Medical and Surgical Sciences Department , Alma Mater Studiorum University of Bologna , Bologna , Italy.

Introduction: Urate-lowering therapy (ULT) is the cornerstone of gout management, which is a widespread chronic illness characterized by hyperuricemia, arthropathy, tophus development, and urolithiasis. Since asymptomatic increased serum urate levels are associated with a higher risk of cardiovascular, renal and metabolic disorders, a larger use of ULTs in the general population is expected in the near future. Areas covered: This review will focus on the safety and tolerability profile of the available urate-lowering drugs: xanthine oxidase inhibitors (XOIs), uricosuric agents and injectable uricases. Read More

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http://dx.doi.org/10.1080/14740338.2019.1594771DOI Listing
March 2019
1 Read

An update on the safety of tacrolimus in kidney transplant recipients, with a focus on tacrolimus minimization.

Expert Opin Drug Saf 2019 Mar 25:1-10. Epub 2019 Mar 25.

a Service de Néphrologie, Hémodialyse, Aphérèses et Transplantation Rénale , CHU Grenoble-Alpes , Grenoble , France.

Introduction: Tacrolimus-based immunosuppression remains the immunosuppressive drug of choice in kidney transplantation. Areas covered: Its safety profile is closely linked to its pharmacokinetic properties. A narrow therapeutic range allows to limit under- and over-immunosuppression consequences. Read More

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http://dx.doi.org/10.1080/14740338.2019.1599858DOI Listing

Safety and immunogenicity of pneumococcal conjugate vaccines in preterm infants.

Expert Opin Drug Saf 2019 Mar 23:1-7. Epub 2019 Mar 23.

a Translational Paediatrics and Infectious Diseases, Department of Paediatrics , Hospital Clínico Universitario de Santiago de Compostela , Santiago de Compostela , Spain.

Introduction: The introduction of pneumococcal conjugate vaccines (PCVs) in the routine immunization program has resulted in a significant decline in invasive pneumococcal diseases (IPD) around the world. Preterm infants are a special group at a high risk of invasive infection by encapsulated bacteria. However, their slow growth accrual and prolonged hospital stay frequently lead to delays in immunization, which contributes to their risk for severe infections. Read More

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http://dx.doi.org/10.1080/14740338.2019.1597849DOI Listing
March 2019
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Surveillance of adverse events following immunization related to human papillomavirus vaccines: 12 years of vaccinovigilance in Southern Italy.

Expert Opin Drug Saf 2019 Mar 23:1-7. Epub 2019 Mar 23.

a Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Department of Experimental Medicine, Section of Pharmacology "L. Donatelli" , University of Campania "Luigi Vanvitelli" , Naples , Italy.

Objectives: Human papillomavirus (HPV) vaccines have proved to be effective in preventing cervical carcinoma. Although their safety profile resembled those of any other vaccine, few clinical studies showed that HPV vaccines might also induce severe adverse events.

Methods: The authors aimed to investigate the safety profile of HPV vaccines, by analyzing the individual case safety reports (ICSRs) of a suspected adverse event following immunization (AEFI) concerning HPV vaccines that were sent to the Italian Pharmacovigilance Spontaneous Reporting System (RNF) in the Campania Region from January 2007 to September 2018. Read More

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https://www.tandfonline.com/doi/full/10.1080/14740338.2019.1
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http://dx.doi.org/10.1080/14740338.2019.1598969DOI Listing
March 2019
3 Reads

Collaboration between patient and pharmacovigilance organizations to gain insight into adults' experiences with drug use and ADRs for the treatment of ADHD.

Expert Opin Drug Saf 2019 Mar 14:1-5. Epub 2019 Mar 14.

a Netherlands Pharmacovigilance Centre Lareb , 's-Hertogenbosch , the Netherlands.

Background: Patient organizations have good access to patients, which can be of interest in gaining knowledge about patients' experiences with drugs. The aim of this study is to investigate if a collaboration between a pharmacovigilance center and an ADHD patient organization can give more insight in patients' experiences with drug use and ADRs for the treatment of AD(H)D.

Methods: Pharmacovigilance Centre Lareb and ADHD patient organization Impuls & Woortblind created a web-based questionnaire asking about patients' experiences with drug use and ADRs. Read More

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http://dx.doi.org/10.1080/14740338.2019.1591366DOI Listing
March 2019
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Letter to editor: comment on 'The need for contraception in patients taking prescription drugs: a review of FDA warning labels, duration of effects, and mechanisms of action' by Zhang et al.

Expert Opin Drug Saf 2019 Mar 1:1-2. Epub 2019 Mar 1.

c Department of Cell Biology , Gottfried Schatz Research Center for Cell Signaling, Metabolism and Aging, Medical University Graz , Graz , Austria.

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http://dx.doi.org/10.1080/14740338.2019.1587887DOI Listing
March 2019
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Understanding the cardiovascular risk with non-insulin antidiabetic drugs.

Expert Opin Drug Saf 2019 Mar 8;18(3):241-251. Epub 2019 Mar 8.

a Second Propedeutic Department of Internal Medicine , Aristotle University , Thessaloniki , Greece.

Introduction: Diabetes mellitus is a major public health problem with significant macro- and microvascular complications. Achievement of glucose control is associated with a substantial reduction of microvascular events, while the effects of antidiabetic drugs in macro-vascular complications are less clear. This review summarizes and critically discusses the cardiovascular effects of non-insulin antidiabetic agents. Read More

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http://dx.doi.org/10.1080/14740338.2019.1586881DOI Listing
March 2019
1 Read

The role of antimicrobial treatment during pregnancy on the neonatal gut microbiome and the development of atopy, asthma, allergy and obesity in childhood.

Expert Opin Drug Saf 2019 Mar 22;18(3):173-185. Epub 2019 Feb 22.

c Division of Surgery , University College London, Northwick Park Institute of Medical Research Campus , London , UK.

Introduction: The use of antibiotics prenatally, during pregnancy, or neonatally may have adverse effects on the neonatal gut microbiome, and adversely affect the development of the infant immune system, leading to childhood atopy, asthma, allergy and obesity. Areas covered: Vaginal eubiosis and dysbiosis from molecular-based, cultivation-independent techniques, and how this affects the neonatal gut microbiome and early development of the immune system, the association between maternal antibiotics and the beneficial role of vitamin D in the development of atopy, asthma, allergy and obesity, efforts to reduce the use of antibiotics in pregnancy and therapeutic interventions such as vaginal 'seeding', probiotics, breastfeeding and neonatal dietary supplementation. Expert opinion: Currently available research gives insufficient attention to confounding variables. Read More

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http://dx.doi.org/10.1080/14740338.2019.1579795DOI Listing
March 2019
5 Reads

Potential strategies to combat the opioid crisis.

Expert Opin Drug Saf 2019 Mar 14;18(3):211-217. Epub 2019 Feb 14.

a Main regional center for pain relief and supportive/palliative care , La Maddalena Cancer Center , Palermo , Italy.

Introduction: In the last few decades, the consumption of opioid analgesics in many countries, particularly the US, has dramatically increased. This rise has been paralleled by a proportional number of opioid-related deaths. Areas covered: The development of opioid guidelines was a response to this health crisis with the intention of reducing the risk of harm related to opioid prescribing. Read More

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http://dx.doi.org/10.1080/14740338.2019.1579796DOI Listing
March 2019
3 Reads

Current state of biologic pharmacovigilance in the European Union: improvements are needed.

Expert Opin Drug Saf 2019 Mar 27;18(3):231-240. Epub 2019 Feb 27.

e Regulatory Affairs, School of Medicine and Health Science , The George Washington University , Washington , DC , USA.

Introduction: Pharmacovigilance is essential to monitoring the safety profiles of authorized medicines. Compared with small-molecule drugs, biological drugs are more complex, more susceptible to structural variability due to manufacturing processes, and have the potential to induce immune-related reactions, underscoring the importance of safety monitoring for these products. Although highly similar to reference products, biosimilars are not expected to be structurally identical. Read More

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http://dx.doi.org/10.1080/14740338.2019.1577818DOI Listing
March 2019
1 Read

Safety of direct oral anticoagulants in real-world clinical practice: translating the trials to everyday clinical management.

Expert Opin Drug Saf 2019 Mar 18;18(3):187-209. Epub 2019 Feb 18.

c Liverpool Centre for Cardiovascular Science , University of Liverpool and Liverpool Heart & Chest Hospital , Liverpool , UK.

Introduction: Direct oral anticoagulants (DOACs) may be regarded as some of the most successful innovations in recent times. These drugs which were specifically developed to overcome the challenges posed by warfarin did just that and in the process, have changed the outlook towards stroke prevention with anticoagulation. The decade of experience with these drugs that has resulted in the availability of large scale data on their safety profile has aided this. Read More

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https://www.tandfonline.com/doi/full/10.1080/14740338.2019.1
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http://dx.doi.org/10.1080/14740338.2019.1578344DOI Listing
March 2019
3 Reads

Making a case for the right '-ase' in acute ischemic stroke: alteplase, tenecteplase, and reteplase.

Expert Opin Drug Saf 2019 Feb;18(2):87-96

d Michigan Neurology Associates, PC , Detroit , MI , USA.

Introduction: Alteplase, reteplase, and tenecteplase are tissue plasminogen activators (TPA) approved for the management of acute myocardial infarction. Only alteplase is also approved for the treatment of acute ischemic stroke (AIS). The US Food and Drug Administration has received reports of accidental administration of tenecteplase or reteplase instead of alteplase in patients with AIS, which can result in failure to treat patients with the intended agent and lead to potential overdose. Read More

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http://dx.doi.org/10.1080/14740338.2019.1573985DOI Listing
February 2019
1 Read

Update upon the infection risk in patients receiving TNF alpha inhibitors.

Expert Opin Drug Saf 2019 Mar 27;18(3):219-229. Epub 2019 Feb 27.

a Clinical Immunology Unit, Department of Internal Medicine , University of Genoa and Ospedale Policlinico San Martino , Genoa , Italy.

Introduction: TNF-α inhibitors can be administered either as monotherapy or in combination with other anti-inflammatory drugs or DMARDs in the treatment of chronic immune-mediated diseases. Areas covered: Patients receiving TNF-α inhibitors are at high risk of infections. An update is made on the risk of infection in patients receiving TNF-α inhibitors and the strategies for mitigating against the development of these serious adverse events. Read More

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http://dx.doi.org/10.1080/14740338.2019.1577817DOI Listing
March 2019
3 Reads

Proton pump inhibitors therapy and the risk of pneumonia: a systematic review and meta-analysis of randomized controlled trials and observational studies.

Expert Opin Drug Saf 2019 Mar 22;18(3):163-172. Epub 2019 Feb 22.

a Department of Emergency Medicine , National Taiwan University Hospital , Taipei , Taiwan.

Objective: We aimed to summarize the current evidence regarding the risk of pneumonia associated with proton pump inhibitors (PPI) treatment.

Methods: We searched PubMed, Embase, and CENTRAL from the 1970 through December 2017. We included both randomized controlled trials (RCTs) and observational studies. Read More

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http://dx.doi.org/10.1080/14740338.2019.1577820DOI Listing
March 2019
1 Read

Safety of recombinant coagulation factors in treating hemophilia.

Expert Opin Drug Saf 2019 Feb 22;18(2):75-85. Epub 2019 Feb 22.

b Department of Hematology , University of Florence , Italy.

Introduction: During the last decade, new FVIII/IX concentrates have been developed for the treatment of patients affected by hemophilia A/B. Significant progress has been achieved regarding their half-life, but the old issue of immunogenicity and new concerns about safety need to be addressed. Areas covered: After the implementation of virucidal methods, both plasma-derived and recombinant clotting factor concentrates achieved a very safe profile. Read More

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http://dx.doi.org/10.1080/14740338.2019.1574743DOI Listing
February 2019

Side effects associated with pharmacotherapy for pediatric irritable bowel syndrome and functional abdominal pain - not otherwise specified: a systematic review.

Expert Opin Drug Saf 2019 Feb 5;18(2):111-125. Epub 2019 Feb 5.

a Pediatric Gastroenterology , Emma Children's Hospital, Amsterdam UMC, University of Amsterdam , Amsterdam , The Netherlands.

Introduction: To systematically review the literature regarding the side effects of pharmacotherapy in children with irritable bowel syndrome (IBS) and functional abdominal pain - not otherwise specified (FAP-NOS). Areas covered: Cochrane Library, PubMed, and Embase databases were searched from inception to May 2018. The following inclusion criteria were applied: (1) randomized controlled trials (RCTs), cohort studies or case-control studies; (2) in children aged 4-18 years or adult studies if children are reported separately; (3) reporting a diagnosis of IBS or FAP-NOS as defined by the authors; and (4) reporting the occurrence of side effects of pharmacotherapy. Read More

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http://dx.doi.org/10.1080/14740338.2019.1574295DOI Listing
February 2019
1 Read

Prescribing in 2019: what are the safety concerns?

Authors:
Jamie J Coleman

Expert Opin Drug Saf 2019 Feb 28;18(2):69-74. Epub 2019 Jan 28.

a Department of Medicine , University Hospitals Birmingham NHS Foundation Trust , Birmingham , UK.

Introduction: Unintended harm from prescribing errors remains a prevalent concern in healthcare leading to significant morbidity and mortality around the world. Prescribers face new challenges to their practice in modern times such as increasingly complex health-care systems, an aging population with increasing multimorbidity, and rapid growth in the number of novel medicines. Areas covered: Prescribing concerns in modern practice are outlined based on seminal literature in this area and the author's continual academic oversight of this topic. Read More

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https://www.tandfonline.com/doi/full/10.1080/14740338.2019.1
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http://dx.doi.org/10.1080/14740338.2019.1571038DOI Listing
February 2019
8 Reads

An update on the safety of prescribing opioids in pediatrics.

Expert Opin Drug Saf 2019 Feb 25;18(2):127-143. Epub 2019 Jan 25.

a Department of Anesthesiology , Cincinnati Children's Hospital , Cincinnati , OH , USA.

Introduction: The opioid abuse epidemic and its toll on the adolescent population have heightened awareness for safer opioid prescribing practices in pediatric pain management. Opioids remain the mainstay of therapy for severe pain, although there is an emphasis on multimodal therapy. Areas covered: In this update, the authors present information on parenteral/oral opioids commonly used in pediatrics. Read More

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http://dx.doi.org/10.1080/14740338.2019.1571037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6446903PMC
February 2019
5 Reads

Safety of clinical practice guideline-recommended antiemetic agents for the prevention of acute chemotherapy-induced nausea and vomiting in pediatric patients: a systematic review and meta-analysis.

Expert Opin Drug Saf 2019 Feb 25;18(2):97-110. Epub 2019 Jan 25.

a Leslie Dan Faculty of Pharmacy , University of Toronto , Toronto , Canada.

Introduction: Chemotherapy-induced nausea and vomiting (CINV) are among the most distressing and feared treatment-related adverse effects for cancer patients. Selection of antiemetic agents to prevent CINV should be based on an evaluation of their efficacy and safety. This systematic review and meta-analysis describes the adverse effects associated with antiemetic agents recommended for the prevention of acute CINV in children by clinical practice guidelines (CPGs). Read More

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https://www.tandfonline.com/doi/full/10.1080/14740338.2019.1
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http://dx.doi.org/10.1080/14740338.2019.1568988DOI Listing
February 2019
7 Reads

The safety of lanreotide for neuroendocrine tumor.

Expert Opin Drug Saf 2019 Jan 24;18(1):1-10. Epub 2018 Dec 24.

a Gastrointestinal Oncology Program and Experimental therapeutics, Division of Hematology/Oncology , Tufts Medical Center - Tufts University School of Medicine , Boston , MA , USA.

Introduction: Lanreotide autogel is a synthetic somatostatin analogue which has been FDA and EMA approved for unresectable, well to moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumor. Its action is mediated by its affinity to somatostatin receptors, especially sst2 and sst5 receptors. Its longer half-life offers the convenience of 4-week dosing over the need for frequent injections of short-acting somatostatin analogues. Read More

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https://www.tandfonline.com/doi/full/10.1080/14740338.2019.1
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http://dx.doi.org/10.1080/14740338.2019.1559294DOI Listing
January 2019
3 Reads
2.911 Impact Factor

Adverse event reporting patterns of concomitant botanical dietary supplements with CYP3A4 interactive & CYP3A4 non-interactive anticancer drugs in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).

Expert Opin Drug Saf 2019 Feb 27;18(2):145-152. Epub 2018 Dec 27.

a Department of Health Outcomes Research and Policy , Auburn University Harrison School of Pharmacy , Auburn , AL , USA.

Background: To examine the adverse event (AE) reporting patterns for concomitant Botanical Dietary Supplements (BDS) and anticancer drugs.

Research Design And Methods: Using the 2004-2015 U.S. Read More

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http://dx.doi.org/10.1080/14740338.2019.1562546DOI Listing
February 2019
1 Read

Calciphylaxis-as a drug induced adverse event.

Expert Opin Drug Saf 2019 01 24;18(1):29-35. Epub 2018 Dec 24.

d Division of Nephrology, Department of Medicine , Massachusetts General Hospital , Boston , MA , USA.

Introduction: Calciphylaxis is a rare but devastating disease with a mortality rate up to 50% in 1 year. It is characterized by profoundly painful ischemic skin lesions and vascular calcification that affects predominantly patients with end stage renal disease. The use of certain medications is an important modifiable risk factor in calciphylaxis and discontinuation of these is a mainstay of treatment. Read More

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http://dx.doi.org/10.1080/14740338.2019.1559813DOI Listing
January 2019
8 Reads

The quality of spontaneous adverse drug reaction reports from the pharmacovigilance centre in western China.

Expert Opin Drug Saf 2019 Jan 21;18(1):51-58. Epub 2018 Dec 21.

a The Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy , Xi'an Jiaotong University , Xi'an , Shannxi , China.

Background: High-quality adverse drug reaction (ADR) reports are essential for conducting drug safety monitoring in pharmacovigilance. The study aim was to assess the current quality of ADR reports in western China, and to identify problems with ADR report quality.

Research Design And Methods: A sample of 1139 reports received by the Shaanxi ADR Monitoring Center from January 2015 to December 2017 was selected. Read More

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http://dx.doi.org/10.1080/14740338.2019.1559812DOI Listing
January 2019
1 Read

Approaches to monitoring intussusception following rotavirus vaccination.

Expert Opin Drug Saf 2019 01 26;18(1):21-27. Epub 2018 Dec 26.

a Viral Gastroenteritis Branch, Division of Viral Diseases , National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention , Atlanta , USA.

Introduction: In 1998, the first licensed rotavirus vaccine was associated with intussusception, an unexpected adverse event, following reports of this condition to an adverse event reporting system. This rotavirus vaccine was withdrawn from the market and newer rotavirus vaccines have been extensively evaluated for an association with intussusception.

Areas Covered: We review the different study designs that have been used both pre- and post-licensure to evaluate the association of rotavirus vaccines with intussusception and discuss the pros and cons of each design. Read More

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https://www.tandfonline.com/doi/full/10.1080/14740338.2019.1
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http://dx.doi.org/10.1080/14740338.2019.1561857DOI Listing
January 2019
15 Reads

Letter to the editor: Efficacy and safety of a combination of HER2-targeted agents as first-line treatment for metastatic HER2-positive breast cancer: a network meta-analysis.

Expert Opin Drug Saf 2018 Dec 7. Epub 2018 Dec 7.

a Department of Oncology , Weifang Traditional Chinese hospital , Weifang , Shandong , China.

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http://dx.doi.org/10.1080/17446651.2018.1545367DOI Listing
December 2018
1 Read

An update on the clinical consequences of polypharmacy in older adults: a narrative review.

Expert Opin Drug Saf 2018 12 12;17(12):1185-1196. Epub 2018 Dec 12.

a Aging Research Center, Department of Neurobiology , Care Sciences and Society, Karolinska Institutet & Stockholm University , Stockholm , Sweden.

Introduction: Polypharmacy, the use of multiple medications by one individual, is increasingly common among older adults. Caring for the growing number of older people with complex drug regimens and multimorbidity presents an important challenge in the coming years.

Areas Covered: This article reviews the international trends in the prevalence of polypharmacy, summarizes the results from previous reviews on polypharmacy and negative health outcomes, and updates a previous review on the clinical consequences of polypharmacy by focusing on studies published after 2013. Read More

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http://dx.doi.org/10.1080/14740338.2018.1546841DOI Listing
December 2018
2 Reads

Evaluating the safety of emicizumab in patients with hemophilia A.

Expert Opin Drug Saf 2018 Dec 28;17(12):1233-1237. Epub 2018 Nov 28.

a Division of Hematology/Oncology , Icahn School of Medicine , New York , NY , USA.

Introduction: Patients affected by hemophilia A often require frequent prophylactic and therapeutic self-infusion. For those who develop inhibitors, treatment options are limited and mortality is increased. Emicizumab, a bispecific antibody to Factors IXa and X that carries out the function of Factor VIII (FVIII), represents a novel therapeutic approach. Read More

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http://dx.doi.org/10.1080/14740338.2019.1551356DOI Listing
December 2018
17 Reads

Liver safety parameters of ulipristal acetate for the treatment of uterine fibroids: a comprehensive review of the clinical development program.

Expert Opin Drug Saf 2018 12 29;17(12):1225-1232. Epub 2018 Nov 29.

c Medical Affairs and Safety Departments, PregLem S.A. , Service d'Hepato-gastroenterologie et Transplantation, Hôpital Saint-Eloi, INSERM-1183 , Montpellier , France.

Introduction: Uterine fibroids are benign tumors within the uterine wall affecting women. Ulipristal acetate 5 mg was first authorized in the European Union on 23 February 2012, with a post-marketing exposure estimated to be more than 765,000 patients so far. During the post-marketing experience, sporadic cases of liver injury and hepatic failure were reported. Read More

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http://dx.doi.org/10.1080/14740338.2018.1550070DOI Listing
December 2018
35 Reads

Safety of osimertinib in EGFR-mutated non-small cell lung cancer.

Expert Opin Drug Saf 2018 Dec 5;17(12):1239-1248. Epub 2018 Dec 5.

a Medical Oncology Department , Gustave Roussy , Villejuif , France.

Introduction: Osimertinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), specifically designed to inhibit EGFR sensitizing and T790M acquired mutations, minimizing exposure in EGFR-wild-type tissues. Areas covered: Osimertinib use in EGFR-mutated non-small cell lung cancer patients is described, focusing on safety and tolerability from studies supporting its approval. Expert opinion: Osimertinib demonstrated greater efficacy, including CNS activity, compared to chemotherapy, with a manageable safety profile in pretreated T790M+ EGFR-mutated patients, leading to FDA approval in 2015 within record time in the oncology field. Read More

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http://dx.doi.org/10.1080/14740338.2018.1549222DOI Listing
December 2018
26 Reads

Monoclonal antibodies for the treatment of non-hematological tumors: a safety review.

Expert Opin Drug Saf 2018 11 20:1-13. Epub 2018 Nov 20.

a Department of Surgical, Oncological and Oral Sciences, Section of Medical Oncology , University of Palermo , Palermo , Italy.

Introduction: The introduction of monoclonal antibodies (moAbs) into clinical practice revolutionized the treatment strategies in several solid tumors. These agents differ from cytotoxic chemotherapy for their mechanism of action and toxicity. By targeting specific antigens present on healthy cells and modulating immune system activity, these biological drugs are able to generate a wide spectrum of peculiar adverse events that can negatively impact on patients' quality of life. Read More

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https://www.tandfonline.com/doi/full/10.1080/14740338.2018.1
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http://dx.doi.org/10.1080/14740338.2018.1550068DOI Listing
November 2018
14 Reads

A characterization and disproportionality analysis of medication error related adverse events reported to the FAERS database.

Expert Opin Drug Saf 2018 Dec 27;17(12):1161-1169. Epub 2018 Nov 27.

a Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences L. Sacco , "Luigi Sacco" University Hospital, Università di Milano , Milan , Italy.

Objectives: To characterize adverse reactions associated with medication errors (ME) reported in US Food and Drug Administration Adverse Event Reporting System (US-FAERS), and to identify the potential signals of disproportionate reporting (SDR) for different drugs.

Methods: ME associated Individual Case Study Report (ICSRs) were identified. ICSRs were categorized by patient age groups, affected stages of medication process and Anatomical Therapeutic Chemical classification system. Read More

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https://www.tandfonline.com/doi/full/10.1080/14740338.2018.1
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http://dx.doi.org/10.1080/14740338.2018.1550069DOI Listing
December 2018
9 Reads

How safe is rucaparib in ovarian cancer?

Expert Opin Drug Saf 2018 Nov 19. Epub 2018 Nov 19.

a Department of Obstetrics and Gynecology , The Ohio State University Wexner Medical Center , Columbus.

Introduction: Rucaparib is increasingly being utilized for women with recurrent ovarian cancer both as treatment and maintenance therapy. PARP inhibitors like rucaparib are daily oral medication that exploit the DNA repair pathway. The most significant clinical benefit is in those tumors exhibiting deficiency in their homologous recombination pathway. Read More

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http://dx.doi.org/10.1080/14740338.2018.1550067DOI Listing
November 2018
34 Reads

Safety evaluation of adalimumab in immune-mediated inflammatory disorders: a rheumatological point of view.

Expert Opin Drug Saf 2019 Jan 17;18(1):11-19. Epub 2018 Dec 17.

a Leeds Institute of Rheumatic & Musculoskeletal Medicine , University of Leeds , Leeds , UK.

Introduction: Immune-mediated inflammatory disorders (IMIDs) are systemic conditions which arise secondary to complex immune mechanism defects and can affect many organs. While previous therapies based on steroids and immunosuppressive agents had a poor risk/benefit balance, TNFα-specific inhibitors such as adalimumab have revolutionized the course of many diseases and patient outcomes. However, concerns were raised regarding the increased risk of infectious diseases and neoplasia due to potential prospective loss of immune control. Read More

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http://dx.doi.org/10.1080/14740338.2018.1549541DOI Listing
January 2019
12 Reads

The safety of dinutuximab for the treatment of pediatric patients with high-risk neuroblastoma.

Expert Opin Drug Saf 2018 Dec 28;17(12):1257-1262. Epub 2018 Nov 28.

a Department of Pediatric Hematology Oncology, Baylor College of Medicine , Texas Children's Hospital , Houston , USA.

Introduction: Dinutuximab, an anti-GD2 antibody, specifically targets the high-expression of GD2 on neuroblastoma cells, and its incorporation into maintenance high-risk neuroblastoma therapy has increased event-free survival for this devastating disease. Efficacy of dinutuximab during other phases of therapy or in relapsed and refractory patients remains under investigation. Areas covered: This review looked at available publications (via PubMed search and online abstract catalogs of recent scientific meetings) on pre-clinical safety studies of dinutuximab as well as results and current impressions of pending trials including dinutuximab and other anti-GD2 antibodies. Read More

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http://dx.doi.org/10.1080/14740338.2018.1549221DOI Listing
December 2018
4 Reads

Should real-world evidence be incorporated into regulatory approvals?

Expert Opin Drug Saf 2018 Nov 9:1-5. Epub 2018 Nov 9.

d International Centre for Circulatory Health, NHLI , Imperial College London , London , UK.

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https://www.tandfonline.com/doi/full/10.1080/14740338.2018.1
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http://dx.doi.org/10.1080/14740338.2018.1546842DOI Listing
November 2018
13 Reads
2.911 Impact Factor

The need for contraception in patients taking prescription drugs: a review of FDA warning labels, duration of effects, and mechanisms of action.

Expert Opin Drug Saf 2018 11 3:1-13. Epub 2018 Nov 3.

a Department of Clinical Laboratory Medicine , Nantong Maternal and Child Health Hospital , Jiangsu , China.

Introduction: 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. Read More

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https://www.tandfonline.com/doi/full/10.1080/14740338.2018.1
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http://dx.doi.org/10.1080/14740338.2018.1544617DOI Listing
November 2018
6 Reads

Safety of ambroxol in the treatment of airway diseases in adult patients.

Expert Opin Drug Saf 2018 Dec 22;17(12):1211-1224. Epub 2018 Nov 22.

c Global Medical Affairs , Sanofi Aventis Deutschland GmbH , Frankfurt am Main , Germany.

Introduction: 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. Read More

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https://www.tandfonline.com/doi/full/10.1080/14740338.2018.1
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http://dx.doi.org/10.1080/14740338.2018.1533954DOI Listing
December 2018
31 Reads

Antimalarial drugs for treating and preventing malaria in pregnant and lactating women.

Expert Opin Drug Saf 2018 Nov 23;17(11):1129-1144. Epub 2018 Oct 23.

a Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine , Mahidol University , Tak , Thailand.

Introduction: 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. Read More

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http://dx.doi.org/10.1080/14740338.2018.1535593DOI Listing
November 2018
20 Reads