1,697 results match your criteria Expert Opinion on Drug Safety[Journal]


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 Feb 11. Epub 2019 Feb 11.

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 the development of childhood atopy, asthma, allergy and obesity. Areas covered: We reviewed new evidence about 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 in infants. We have considered the association between maternal use of antibiotics and the potentially beneficial role of vitamin D in the development of atopy, asthma, allergy and obesity. Read More

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http://dx.doi.org/10.1080/14740338.2019.1579795DOI Listing
February 2019

Potential strategies to combat the opioid crisis.

Expert Opin Drug Saf 2019 Feb 5:1-7. Epub 2019 Feb 5.

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
February 2019
3 Reads

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

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

d 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
February 2019

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

Expert Opin Drug Saf 2019 Feb 2. Epub 2019 Feb 2.

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

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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http://dx.doi.org/10.1080/14740338.2019.1578344DOI Listing
February 2019

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

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

d Michigan Neurology Associates, PC , Detroit , MI .

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

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

Expert Opin Drug Saf 2019 Jan 31. Epub 2019 Jan 31.

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
January 2019
1 Read

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 Jan 31. Epub 2019 Jan 31.

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
January 2019
1 Read

Safety of recombinant coagulation factors in treating hemophilia.

Expert Opin Drug Saf 2019 Jan 25. Epub 2019 Jan 25.

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
January 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 5:1-15. 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

Prescribing in 2019: what are the safety concerns?

Authors:
Jamie J Coleman

Expert Opin Drug Saf 2019 Jan 18:1-6. Epub 2019 Jan 18.

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
January 2019
3 Reads

An update on the safety of prescribing opioids in pediatrics.

Expert Opin Drug Saf 2019 Jan 16:1-17. Epub 2019 Jan 16.

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
January 2019
1 Read

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 Jan 14:1-14. Epub 2019 Jan 14.

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
January 2019
3 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
1 Read
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 2018 Dec 21. Epub 2018 Dec 21.

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

Background: To examine 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
December 2018

Calciphylaxis-as a drug induced adverse event.

Expert Opin Drug Saf 2019 Jan 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
1 Read

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

Approaches to monitoring intussusception following rotavirus vaccination.

Expert Opin Drug Saf 2019 Jan 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
7 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

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

Expert Opin Drug Saf 2018 Dec 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
1 Read

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
11 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 Dec 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
23 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
16 Reads

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

Expert Opin Drug Saf 2018 Nov 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
10 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
8 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
27 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
7 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
3 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
6 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 Nov 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
5 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
20 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
9 Reads

The safety of apatinib for the treatment of gastric cancer.

Expert Opin Drug Saf 2018 Nov 24;17(11):1145-1150. Epub 2018 Oct 24.

d Department of Medical Oncology, Peking Union Medical College Hospital , Chinese Academy of Medical Sciences , Beijing , China.

Introduction: Apatinib is an orally administered small-molecule vascular endothelial growth factor receptor 2 inhibitor. It has been approved and indicated for advanced gastric cancer after the failure of two or more lines of systemic therapy in China. Areas covered: This review summarizes the mechanisms, clinical applications and safety evaluations of apatinib. 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/10.1080/14740338.2018.1535592DOI Listing
November 2018
7 Reads

Safety concerns when using novel medications to treat alopecia.

Expert Opin Drug Saf 2018 Nov 25;17(11):1115-1128. Epub 2018 Oct 25.

b Department of Dermatology and Cutaneous Surgery , University of Miami Miller School of Medicine , Miami , FL , USA.

Introduction: Alopecia is often a cause of great concern to patients for cosmetic and psychologic reasons. The aim of treating non-scarring alopecias is to reduce hair loss and, to some extent, enhance hair regrowth. However, therapies for scarring alopecias are limited and aiming to halt disease progression. 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/10.1080/14740338.2018.1533549DOI Listing
November 2018
42 Reads

The safety of bevazicumab for the treatment of ovarian cancer.

Expert Opin Drug Saf 2018 Nov 10;17(11):1107-1113. Epub 2018 Oct 10.

b Department of Clinical and Experimental Medicine , Gynecologic and Obstetrics Unit, University of Sassari , Sassari , Italy.

Introduction: The safety profile of bevacizumab (BV) remains a challenging issue, in particular its role in fragile OC patients. Areas covered: In this literature review, we have analyzed safety data from Phase III trials evaluating the combination of BV plus standard chemotherapy in advanced or recurrent OC patients. In particular, our review aimed at clarifying the impact of the drug on fragile patients, and the correlation between BV and postoperative complications after cytoreductive surgery. Read More

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http://dx.doi.org/10.1080/14740338.2018.1532500DOI Listing
November 2018
1 Read

The usefulness of listening social media for pharmacovigilance purposes: a systematic review.

Expert Opin Drug Saf 2018 Nov 12;17(11):1081-1093. Epub 2018 Oct 12.

a Unit of Pharmacology and Pharmacovigilance , University of Pisa , Pisa , Italy.

Introduction: Social media mining could be a possible strategy to retrieve drug safety information. The mining of social media is a complex process under progressive evolution, falling into three broad categories: listening (safety data reporting), engaging (follow-up), and broadcasting (risk communication). This systematic review is aimed at evaluating the usefulness and quality of proto-signals by social media listening. 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/10.1080/14740338.2018.1531847DOI Listing
November 2018
13 Reads

Optimal management of patients with hepatocellular carcinoma treated with lenvatinib.

Expert Opin Drug Saf 2018 Nov 12;17(11):1095-1105. Epub 2018 Oct 12.

d Department of Gastroenterology , Kanazawa University Hospital , Kanazawa , Japan.

Introduction: Lenvatinib, a multi-kinase inhibitor, has demonstrated improved outcomes for patients with hepatocellular carcinoma (HCC) in clinical trials. The phase 3 REFLECT trial confirmed the noninferiority of lenvatinib to sorafenib for overall survival of HCC patients and indicated clinical benefits in efficacy over sorafenib. Adverse events (AEs) included hypertension, diarrhea, decreased appetite, decreased weight, fatigue, palmar-plantar erythrodysesthesia, and proteinuria. Read More

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http://dx.doi.org/10.1080/14740338.2018.1530212DOI Listing
November 2018

Long-term outcome in patients with non-valvular atrial fibrillation on dabigatran: a prospective cohort study.

Expert Opin Drug Saf 2018 Nov 8;17(11):1063-1069. Epub 2018 Oct 8.

b Internal, Vascular and Emergency Medicine - Stroke Unit , University of Perugia , Perugia , Italy.

Introduction: Most studies on thromboembolic and bleeding risk in patients with non-valvular atrial fibrillation (NVAF) exposed to non-vitamin K oral anticoagulants stem from interrogation of insurance databases. Areas covered: We studied 742 consecutive patients with NVAF who started treatment with dabigatran in three hospitals in Italy. Average follow-up was 1. Read More

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http://dx.doi.org/10.1080/14740338.2018.1529166DOI Listing
November 2018
15 Reads

Analyzing intent-to-treat and per-protocol effects on safety outcomes using a medical information database: an application to the risk assessment of antibiotic-induced liver injury.

Expert Opin Drug Saf 2018 Nov 4;17(11):1071-1079. Epub 2018 Oct 4.

a Department of Biostatistics, School of Public Health, Graduate School of Medicine , The University of Tokyo , Tokyo , Japan.

Objective: To apply a causal analysis approach to estimate the intent-to-treat and per-protocol effects in a safety outcome study of the 30-day risk of liver injury associated with antibiotic use (macrolides, penicillin-based antibiotics, and fluoroquinolones).

Research Design And Methods: For each antibiotic class, we constructed a pooled cohort of treated episodes matched with untreated episodes using an electronic medical record database from a university hospital. High-dimensional propensity scores were calculated using baseline patient characteristics, concomitant medications and medical history as surrogate confounders. Read More

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http://dx.doi.org/10.1080/14740338.2018.1528224DOI Listing
November 2018

Gender differences on benefits and risks associated with oral antithrombotic medications for coronary artery disease.

Expert Opin Drug Saf 2018 Oct 23;17(10):1041-1052. Epub 2018 Sep 23.

a Division of Cardiology , CAST, P.O. "Rodolico", Azienda Ospedaliero-Universitaria "Policlinico-Vittorio Emanuele", University of Catania , Catania , Italy.

Introduction: Despite the significant advances in the pharmacological and interventional management of patients with cardiovascular disease (CVD) over the last decades, cardiovascular mortality remains the leading cause of death. Large randomized clinical trials have investigated the efficacy and safety of different antithrombotic medications in patients with CVD. Although female gender is generally underrepresented in these clinical trials, most analyses clearly indicate that both men and women may accrue therapeutic benefits from antithrombotic management strategies. Read More

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http://dx.doi.org/10.1080/14740338.2018.1524869DOI Listing
October 2018
2 Reads

The efficacy and safety of memantine for the treatment of Alzheimer's disease.

Expert Opin Drug Saf 2018 Oct 26;17(10):1053-1061. Epub 2018 Sep 26.

b Department of Psychiatry , Fujita Health University School of Medicine , Toyoake , Aichi , Japan.

Introduction: Currently, five pharmacotherapeutic options are available to treat Alzheimer's disease: memantine; the three cholinesterase inhibitors donepezil, galantamine, and rivastigmine; and combination treatments with memantine and one cholinesterase inhibitor. Selection of the best course of treatment is based upon the evidence gathered by systematic reviews and meta-analyses of randomized controlled trials. Areas covered: This article provides a risk-benefit analysis of these treatments using evidence from meta-analyses on their safety and their efficacy. Read More

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http://dx.doi.org/10.1080/14740338.2018.1524870DOI Listing
October 2018
4 Reads

Drug-induced bone loss: a major safety concern in Europe.

Expert Opin Drug Saf 2018 Oct 23;17(10):1005-1014. Epub 2018 Sep 23.

a Laboratoire de Pharmacologie Médicale et Clinique, Equipe de Pharmacoépidémiologie de l'UMR INSERM 1027, Faculté de Médecine de l'Université Paul-Sabatier et Centre Midi-Pyrénées de PharmacoVigilance , de Pharmacoépidémiologie et d'Information sur le Médicament de l'UMR INSERM 1027, Centre Hospitalier Universitaire , Toulouse , France.

Introduction: Drug-induced bone loss remains the major cause of vertebral and hip fractures and significantly associated to morbidity and mortality. This article will review the common drugs identified as the causes of bone loss and the risk factors and management in European countries. Areas covered: Beyond glucorticoid - the most cause of osteoporosis, many different drugs could cause harmful skeletal disorders. Read More

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http://dx.doi.org/10.1080/14740338.2018.1524868DOI Listing
October 2018
2 Reads

Safety and efficacy of propofol anesthesia for pediatric target-controlled infusion in children below 3 years of age: a retrospective observational study.

Expert Opin Drug Saf 2018 Oct 22;17(10):983-989. Epub 2018 Sep 22.

a Department of Anesthesiology and Pain Medicine , Seoul National University Hospital , Seoul , Republic of Korea.

Background: Although the requirement of propofol in children is increasing, propofol for induction and maintenance of anesthesia below 3 years old has not been approved in Korea. This study can provide a clinical evidence to increase the range of approval.

Research Design And Methods: We reviewed the medical records of patients below 3 years of age who underwent surgery between September 2013 and December 2016. Read More

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http://dx.doi.org/10.1080/14740338.2018.1524460DOI Listing
October 2018
4 Reads

The FDA Animal Rule and its role in protecting human safety.

Authors:
Theresa Allio

Expert Opin Drug Saf 2018 Oct 12;17(10):971-973. Epub 2018 Sep 12.

a Theresa Allio LLC , Millburn , NJ , USA.

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http://dx.doi.org/10.1080/14740338.2018.1518429DOI Listing
October 2018

Drugs that increase the risk of community-acquired pneumonia: a narrative review.

Expert Opin Drug Saf 2018 Oct 17;17(10):991-1003. Epub 2018 Sep 17.

b Department of Pneumology, Institut Clinic del Tórax, Hospital Clinic of Barcelona - Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) , University of Barcelona (UB) - SGR 911 - Ciber de Enfermedades Respiratorias (Ciberes) , Barcelona , Spain.

Introduction: Community-acquired pneumonia (CAP), a major cause of morbidity and mortality, is the leading infectious cause of death in the developed world. Population-based studies and systematic reviews have identified a large number of risk factors for the development of pneumonia in adults. In addition to age, lifestyle habits, and comorbidities, some forms of pharmacotherapy may also increase the risk for CAP. 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/10.1080/14740338.2018.1519545DOI Listing
October 2018
19 Reads

Moxifloxacin-induced QT interval prolongation and torsades de pointes: a narrative review.

Expert Opin Drug Saf 2018 Oct 17;17(10):1029-1039. Epub 2018 Sep 17.

a Department of Pharmacy , University of Peshawar , Peshawar , Khyber Pakhtunkhwa , Pakistan.

Introduction: Moxifloxacin is widely used for the treatment of a number of infectious diseases because of its favorable pharmacological profile and high clinical success rate. However, it is often criticized for its higher risk of QTc interval prolongation (QTIP) and torsades de pointes (TdP). Areas covered: A review of published literature on moxifloxacin-related QTIP and TdP. Read More

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http://dx.doi.org/10.1080/14740338.2018.1520837DOI Listing
October 2018
2 Reads

Safety and tolerability profile of new antiepileptic drug treatment in children with epilepsy.

Expert Opin Drug Saf 2018 Oct 17;17(10):1015-1028. Epub 2018 Sep 17.

a Child Neurology and Psychiatry Unit, Systems Medicine Department , Tor Vergata University of Rome , Rome , Italy.

Introduction: Treatment of pediatric epilepsy requires a careful evaluation of the safety and tolerability profile of antiepileptic drugs (AEDs) to avoid or minimize as much as possible adverse events (AEs) on various organs, hematological parameters, and growth, pubertal, motor, cognitive and behavioral development. Areas covered: Treatment-emergent AEs (TEAEs) reported in the literature 2000-2018 regarding second- and third-generation AEDs used in the pediatric age, with exclusion of the neonatal period that exhibits specific peculiarities, have been described on the basis of their frequency, severity/tolerability, and particular association with a given AED. Expert opinion: Somnolence/sedation and behavioral changes, like irritability and nervousness, are among the most commonly observed TEAEs associated with almost all AEDs. Read More

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http://dx.doi.org/10.1080/14740338.2018.1518427DOI Listing
October 2018
2 Reads

An overview of properties of Amphora (Acidform) contraceptive vaginal gel.

Authors:
Anita L Nelson

Expert Opin Drug Saf 2018 Sep 3;17(9):935-943. Epub 2018 Sep 3.

a Department of Obstetrics and Gynecology , Western University of Health Sciences , Pomona , CA , USA.

Introduction: Although only a minority of contracepting women rely solely on spermicides, they may soon be the only ongoing female method available without a prescription in the United States. Spermicides are also combined with other methods for additional pregnancy protection and/or lubrication. Nonoxynol-9 (N-9), the active ingredient in most spermicides, is cytotoxic and may increase risk of transmission of HIV and other sexually transmitted infections, especially in high-risk women. Read More

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http://dx.doi.org/10.1080/14740338.2018.1515197DOI Listing
September 2018
16 Reads

Cardiovascular safety of oncologic agents: A double-edged sword even in the era of targeted therapies - part 1.

Expert Opin Drug Saf 2018 Sep 1;17(9):875-892. Epub 2018 Sep 1.

d Third Department of Cardiology , Athens University School of Medicine , Athens , Greece.

Introduction: Patients with cancer are subject to the cardiotoxic effects of cancer therapy and as more patients survive cancer due to improved treatment they are exposed to various forms of cardiovascular (CV) disease as they age, and vice-versa. Such an interplay of age with both malignancy and CV disease may contribute to increased morbidity and mortality. Areas covered: This two-part review considers the effects of cancer drug treatment on the CV system. Read More

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http://dx.doi.org/10.1080/14740338.2018.1513488DOI Listing
September 2018
2 Reads

Cardiovascular safety of oncologic agents: a double-edged sword even in the era of targeted therapies - Part 2.

Expert Opin Drug Saf 2018 Sep 17;17(9):893-915. Epub 2018 Sep 17.

d Third Department of Cardiology , Athens University School of Medicine , Athens , Greece.

Introduction: Patients with cancer are subject to the cardiotoxic effects of cancer therapy. Improved cancer treatments lead to more cancer-survivors, who though are exposed to various forms of cardiovascular (CV) disease (CVD) as they age. Aging patients are at increased risk of developing both malignancy and CVD or they may have survived some form of CVD as a result of effective CV treatments. Read More

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http://dx.doi.org/10.1080/14740338.2018.1513489DOI Listing
September 2018
3 Reads