Benefit-risk review of different drug classes used in chronic heart failure.
Authors: Andries G, Yandrapalli S, Aronow WS Abstract INTRODUCTION: Heart failure (HF) is an important public health problem with an increasing prevalence across the globe. The mortality rates from this complex clinical problem have stabilized in the recent years with the use of pharmacotherapeutics which demonstrated survival benefits in patients with HF with reduced ejection fraction (HFrEF). Areas Covered: We reviewed the 7 classes of medications which constitute the guideline-directed medical therapy (GDMT) in chronic HF patients. We discussed clinical trials which support or contradict their use, potential adv...
Source: Expert Opinion on Drug Safety - August 18, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The inhibition of first-pass metabolism of ethanol by H2-receptor antagonists: a tabulated review.
Authors: Moody DE Abstract INTRODUCTION: In the 1980-90s numerous studies were performed on H2-receptor antagonist inhibition of ethanol first pass metabolism. Blood alcohol concentrations warranting possible driving under the influence citations in the United States have subsequently dropped from ≥ 100 mg/dL to 50 mg/dL (Utah in 2019) (30 mg/dL or zero tolerance in some parts of the world). A reexamination of these studies seemed important. Areas covered: Papers were compiled that addressed the effect of cimetidine, ranitidine, famotidine, and nizatidine on ethanol metabolism first from a PubMed search and then...
Source: Expert Opinion on Drug Safety - August 18, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of bortezomib for the treatment of multiple myeloma.
Authors: Cengiz Seval G, Beksac M Abstract INTRODUCTION: There is now 16 years' worth of established results of various trials demonstrating the bortezomib efficiency in the treatment of multiple myeloma. Over this time, the introduction of bortezomib has been a major break through in the treatment of multiple myeloma. Bortezomib can be administered in the outpatient setting with manageable toxicities. Areas covered: A literature search was carried out using PubMed and Google Scholar. This review gives an overview of the critical role of the bortezomib in multiple myeloma and provides a comprehensive summary of key...
Source: Expert Opinion on Drug Safety - August 18, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Measuring the impact of the 2012 European pharmacovigilance legislation on additional risk minimization measures.
CONCLUSION: During the study period, no significant differences in the proportion or trend of products with aRMMs at the time of licensing before and after the pharmacovigilance legislation were identified. PMID: 30107752 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - August 17, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of beclomethasone dipropionate in the treatment of ulcerative colitis.
Authors: Rizzello F, Mazza M, Salice M, Calabrese C, Calafiore A, Campieri M, Gionchetti P Abstract INTRODUCTION: Beclomethasone dipropionate (BDP) is a second-generation corticosteroid that use novel drug technologies to ensure colonic targeting and potentially reducing systemic corticosteroid concentrations. It is approved for treatment of patients with mild-to-moderate ulcerative colitis (UC) who do not respond to mesalazine. The gut-selective mechanism of action has the potential to improve the safety profile of beclomethasone dipropionate compared to other conventional corticosteroids. Areas covered: We review...
Source: Expert Opinion on Drug Safety - August 14, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Thyrotropin receptor antibodies and a genetic hint in antithyroid drug-induced adverse drug reactions.
CONCLUSION: Our findings support the use of carbimazole/methimazole in patients with low TRAb titers to ensure safer drug use. The identified genetic associations warrant further research. PMID: 30067105 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - August 4, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of empagliflozin plus metformin for the treatment of type 2 diabetes.
Authors: Scheen AJ Abstract INTRODUCTION: Metformin is the first-line glucose-lowering medication in type 2 diabetes mellitus (T2DM), but it generally requires soon or later the addition of a second-line therapy, among which a sodium-glucose cotransporter type 2 (SGLT-2) inhibitor, to reach and maintain adequate glucose control. Areas covered: This narrative review provides an analysis of both efficacy and safety of a dual therapy combining metformin and empagliflozin, a SGLT-2 inhibitor that has proven its' potential to reduce major cardiovascular (CV) events, mortality, and renal outcomes in patients with T2DM an...
Source: Expert Opinion on Drug Safety - August 4, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Digital medicines: clinical review on the safety of tablets with sensors.
Authors: Plowman RS, Peters-Strickland T, Savage GM PMID: 30073875 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - August 4, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Psoriasis during angiotensin receptor blocker exposure: an underestimated adverse drug reaction.
CONCLUSIONS: This underestimated adverse drug reaction is a class effect, time to onset is most often less than 1 year and outcome seems favorable after ARB discontinuation. The case/non-case approach highlights a potential safety signal. The SmPC of ARBs should be updated, and increased awareness among healthcare professionals is warranted. PMID: 30073879 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - August 4, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of ramucirumab for the treatment of colorectal cancer.
Authors: Noguerido A, Mulet-Margalef N, Matos I, Ros J, Argilés G, Élez E, Tabernero J Abstract INTRODUCTION: Ramucirumab, a human monoclonal antibody against vascular endothelial growth factor receptor 2 (VEGFR-2), is an antiangiogenic therapy that has been approved in combination with FOLFIRI in second-line treatment of metastatic colorectal cancer (mCRC), after progression on or after therapy with bevacizumab, oxaliplatin and a fluoropyrimidine. A thorough review of the safety of ramucirumab in this setting and in the context of other antiangiogenic agents is merited. Areas covered: We provide an o...
Source: Expert Opinion on Drug Safety - August 4, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Multiple sclerosis as an adverse drug reaction: clues from the FDA Adverse Event Reporting System.
CONCLUSION: Our findings add weight to the evidence suggesting that immunomodulatory drugs increase the risk of MS and point out that some other drug classes should be further investigated for this risk. PMID: 30058390 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - August 1, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Drug-induced liver injury: a safety review.
Authors: García-Cortés M, Ortega-Alonso A, Lucena MI, Andrade RJ Abstract INTRODUCTION: Idiosyncratic drug-induced liver injury (DILI) remains one of the most important causes of drug attrition both in the early phases of clinical drug development and in the postmarketing scenario. This is because, in spite of emerging data on genetic susceptibility variants associated to the risk of hepatotoxicity, the precise identification of the individual who will develop DILI when exposed to a given drug remains elusive. Areas covered: In this review, we have addressed recent progress made and initiatives taken ...
Source: Expert Opinion on Drug Safety - August 1, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Does public perception bias lead to more frequent reporting of adverse events: branded vs generic drugs.
Authors: Qian J, Mishuk AU, Hansen RA PMID: 30052091 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 29, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Comparative study of the effect of bilastine and cetirizine on cognitive functions at ground level and at an altitude of 4,000 m simulated in hypobaric chamber: a randomized, double-blind, placebo-controlled, cross-over study.
CONCLUSIONS: From the two examined antihistamines, bilastine should be the preferred medication for by individuals who require constant attention and are exposed to hypobaric hypoxia. PMID: 30032673 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 25, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety review of proton pump inhibitors to treat acid-related digestive diseases.
Authors: Savarino E, Marabotto E, Zentilin P, Furnari M, Bodini G, Pellegatta G, Lorenzon G, Della Coletta M, Ghisa M, Coppo C, Marinelli C, Savarino V Abstract INTRODUCTION: Proton pump inhibitors (PPIs) have become the first choice medical treatment of acid-related disease and, as with any pharmacological agent, they have been reported to be associated with some adverse events mainly linked to their chronic use. The most important postulated harms are represented by serum electrolyte alterations, vitamin B12 and iron deficiency, gastric tumors, enteric infections, spontaneous bacterial peritonitis, pneumonia, isc...
Source: Expert Opinion on Drug Safety - July 25, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Rationale for administering beta-blocker therapy to patients undergoing coronary artery bypass surgery: a systematic review.
Authors: Thaper A, Kulik A Abstract INTRODUCTION: Secondary preventative therapies are essential for patients undergoing coronary artery bypass graft (CABG) surgery to optimize perioperative and long-term outcomes. Beta-blockers are commonly used to treat patients with coronary artery disease and congestive heart failure, but their role for CABG patients remains unclear. The goal of this systematic review was to evaluate the rationale for administering beta-blockers to the CABG population and to assess their efficacy before and after coronary surgical revascularization. Areas covered: A systematic literature review...
Source: Expert Opinion on Drug Safety - July 25, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Evaluating Twitter as a complementary data source for pharmacovigilance.
CONCLUSIONS: With the use of dedicated tools, Twitter could become a complementary source of information for pharmacovigilance, despite a major limitation regarding causality assessment of ADRs in individual tweets, which may improve with the new limitation to 280 characters per tweet. PMID: 29991282 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 12, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A Narrative Review of Problems with Medicines Use in People with Dementia.
Authors: Eshetie TC, Nguyen TA, Gillam MH, Kalisch Ellett LM Abstract INTRODUCTION: People with dementia may be particularly susceptible to medication related problems for various reasons. They include progressive cognitive decline, high sensitivity to the effect of medications on cognition and memory and increased likelihood of comorbidities. Areas covered: This paper aimed to review current literature on the frequency and the types of medication related problems, and their contribution to hospital admission in people with dementia. Literature searches were conducted using key search terms of dementia and medicati...
Source: Expert Opinion on Drug Safety - July 12, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of DPP-4 inhibitor and SGLT2 inhibitor combination therapies.
Authors: Molina-Vega M, Muñoz-Garach A, Fernández-García JC, Tinahones FJ Abstract INTRODUCTION: Type 2 diabetes (T2D), a multifactorial and chronic disease, requires in an elevated percentage of patients the association of several antidiabetic drugs to achieve optimal glycemic control. Dipeptidyl peptidase-4 inhibitors (DPP-4i) and sodium-glucose cotransporter inhibitors (SGLT2i) are new classes of oral antidiabetic drugs developed over the last years. Areas covered: This paper summarizes the safety of DPP-4i and SGLT2i combination therapies. Relevant studies were identified through searches i...
Source: Expert Opinion on Drug Safety - July 6, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Predictors of Skeletal-Related Events among Cancer Patients with Bone Metastases Treated with Zoledronic Acid: a Secondary Analysis of a Randomized Study.
CONCLUSION: Among advanced cancer patients with bone metastases, lytic nature of metastases, as well as higher body mass index, are associated with a higher probability of SREs. TRIAL REGISTRATION NUMBER: This clinical trial was registered at clinicaltrials.gov with the number: NCT0033. PMID: 29972647 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - July 5, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The economic burden of preventable adverse drug reactions: a systematic review of observational studies.
Authors: Formica D, Sultana J, Cutroneo PM, Lucchesi S, Angelica R, Crisafulli S, Ingrasciotta Y, Salvo F, Spina E, Trifirò G Abstract INTRODUCTION: Adverse drug reactions (ADRs) are an important cause of morbidity and mortality worldwide. They are associated with healthcare costs due to hospital admissions or prolonged length of stay (LOS), as well as additional interventions. The aim of this study was to conduct a systematic review of observational studies to evaluate the economic impact of preventable ADRs. Areas covered: Published observational research investigating the cost of preventable ADRs in Weste...
Source: Expert Opinion on Drug Safety - June 29, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Using Sertraline in Postpartum and Breastfeeding: Balancing Risks and Benefits.
Authors: Cuomo A, Maina G, Neal SM, De Montis G, Rosso G, Scheggi S, Beccarini Crescenzi B, Bolognesi S, Goracci A, Coluccia A, Ferretti F, Fagiolini A Abstract INTRODUCTION: The World Health Organization recommends newborns to be breastfed but this may be challenging if the mother needs to be treated for depression, since strong evidence to inform treatment choice is missing. Areas covered: We provide a critical review of the literature to guide clinicians who are considering sertraline for the management of depression during postpartum. Expert opinion: Sertraline is one of the safest antidepressants during breast...
Source: Expert Opinion on Drug Safety - June 22, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety evaluation of Guselkumab for the treatment of psoriasis.
Authors: Galluzzo M, D'Adamio S, Campione E, Bianchi L, Talamonti M Abstract INTRODUCTION: Guselkumab is a fully human monoclonal IgG1λ antibody for the treatment of plaque psoriasis that inhibits interleukin (IL)-23p19 subunit, reducing the proliferation of type 17 helper T (Th-17) cells and thus production of Th-17-derived pro-inflammatory cytokines, especially IL-17 and IL-22. Areas covered: In the following article, the mechanism of action and mainly the efficacy and safety profile of guselkumab available from results of trials will be discussed. We summarized these data after a literature review includi...
Source: Expert Opinion on Drug Safety - June 15, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Antimicrobial resistance and treatment: an unmet clinical safety need.
Authors: Bassetti M, Russo A, Carnelutti A, La Rosa A, Righi E Abstract Introduction Infections due to multidrug-resistant (MDR) bacteria are burdened by high mortality rates. The development of new compounds to face the global threat of resistance is urgently needed. Combination regimens including "old" high-dose antimicrobials are currently limited by the risk of toxicity, resistance selection, and reduced efficacy. Following the Infectious Diseases Society of America call to develop 10 new antibacterials by 2020, new molecules are currently under development or have become available for use in clinical...
Source: Expert Opinion on Drug Safety - June 15, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Anakinra for the treatment of rheumatoid arthritis: a safety evaluation.
Authors: Ramírez J, Cañete JD Abstract INTRODUCTION: The anti-IL-1receptor antagonist, anakinra, was approved for the treatment of rheumatoid arthritis (RA) more than 12 years ago. However, its adverse effects are not well known. Areas covered: We review the safety profile of anakinra, analysing clinical trials, observational studies and registry data. Expert opinion: Due to its lower efficacy compared with other biological therapies approved for RA, and its daily subcutaneous administration, anakinra is used only marginally for the treatment of RA. This has limited the experience with this drug in RA...
Source: Expert Opinion on Drug Safety - June 9, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Adverse Drug Reaction Reporting in Institutions Across Six Chinese Provinces: A Cross-sectional Study.
CONCLUSIONS: The institutions surveyed have established ADR monitoring systems. However, these systems have flaws. Urgent improvements are needed in funding, basic resources, reporting processes, and other pharmacovigilance activities. PMID: 29883236 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - June 9, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Cardiovascular risk factors in patients with rheumatoid arthritis prescribed disease modifying anti-rheumatic drugs.
Authors: Giollo A, Bissell LA, Buch MH Abstract INTRODUCTION: Rheumatoid arthritis (RA) is associated with a heightened risk of cardiovascular disease (CVD), with both traditional CV risk factors and inflammation contributing to this risk. Areas covered: This review highlights the burden of CVD in RA and associated traditional CV risk factors, including the complexity of dyslipidaemia in RA and the so-called 'lipid paradox'. Furthermore, the recognised RA disease specific factors associated with higher risk of CVD and the role of systemic inflammation in the pathogenesis of CVD in RA will be addressed. With the adv...
Source: Expert Opinion on Drug Safety - June 8, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Evaluation of reporting quality for observational studies using routinely collected health data in pharmacovigilance.
CONCLUSION: This study provides the evidence that the reporting quality of post-marketing safety evaluation studies conducted using routinely collected health data was often insufficient. Future stakeholders are encouraged to endorse the RECORD guidelines in pharmacovigilance. PMID: 29857774 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - June 4, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Teduglutide for the treatment of short bowel syndrome - a safety evaluation.
Authors: Kochar B, Herfarth HH Abstract INTRODUCTION: Teduglutide is an analogue of glucagon-like peptide 2 (GLP-2) which is approved for the treatment of patients with short bowel syndrome (SBS) who are dependent on parenteral support. Areas Covered: Short bowel syndrome is a rare condition that can result from extensive resection of small bowel, congenital abnormalities or inflammatory conditions that leads to poor nutrient processing capacity of the intestine. In this review, the safety reported in controlled clinical trials and real-world experience with teduglutide are presented in depth. Expert Opinion: Trial...
Source: Expert Opinion on Drug Safety - June 2, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Risk of opportunistic infections in patients treated with alemtuzumab for multiple sclerosis.
Authors: Buonomo AR, Zappulo E, Viceconte G, Scotto R, Borgia G, Gentile I Abstract INTRODUCTION: Alemtuzumab is a monoclonal anti CD-52 antibody recently approved for use in relapsing-remitting multiple sclerosis(MS). Given that the targeted antigen is primarily expressed on B and T lymphocytes, the administration of this biological drug is associated with rapid but protracted peripheral lymphopenia. Areas covered: The impact on infective risk of this immune impairment is still to be fully understood. In this review, we attempt to summarize all the available literature concerning opportunistic infections occurring...
Source: Expert Opinion on Drug Safety - June 2, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Intolerance to tyrosine kinase inhibitors in chronic myeloid leukemia: the possible role of ponatinib.
Authors: Breccia M, Efficace F, Iurlo A, Luciano L, Abruzzese E, Gozzini A, Pregno P, Tiribelli M, Rosti G, Minotti G Abstract INTRODUCTION: In spite of the proven efficacy of the tyrosine kinase inhibitor (TKI), imatinib, in chronic myeloid leukemia (CML), many patients develop intolerance and discontinue therapy in the long-term. Second-generation TKIs (dasatinib, nilotinib, bosutinib) and the third-generation TKI, ponatinib, have added opportunities but also complexity in the settings of CML treatment. Areas covered: Different definitions of intolerance have been used through several clinical trials, making the ...
Source: Expert Opinion on Drug Safety - June 1, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

How to address the placebo response in the prescription SSRIs and SNRIs in children and adolescents.
Authors: Koechlin H, Kossowsky J, Gaab J, Locher C Abstract SSRIs and SNRIs are prescribed as first-line pharmacological treatment for common mental disorders in children and adolescents. Despite their efficacy, they have a high risk for adverse events and exhibit a substantial placebo response. This editorial provides some background on the current evidence on the topic and suggests to carefully weigh the benefits of SSRIs and SNRIs against their potential harms. Therefore, the authors present two different set of conclusions - one for clinical practice, and one for future research designs. PMID: 29781324 [Pub...
Source: Expert Opinion on Drug Safety - May 25, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Is it clinically defensible to treat children longer term with second generation antipsychotics?
Authors: Hazell P PMID: 29781325 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 25, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Posology adjustments of oral antineoplastic agents for special populations: patients with renal impairment, hepatic impairment and hematologic toxicities.
CONCLUSIONS: Most OAA have to be adjusted in special situations. Given the number of OAA available for different indications, this review can serve as an easy tool to help health professionals dose these complex treatments. PMID: 29781751 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 25, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Current and potential treatment options for hyperphosphatemia.
Authors: Carfagna F, Del Vecchio L, Pontoriero G, Locatelli F Abstract INTRODUCTION: Hyperphosphatemia is common in late stages of chronic kidney disease and is often associated with elevated parathormone levels, abnormal bone mineralization, extra-osseous calcification, and increased risk of cardiovascular events and death. Several classes of oral phosphate binders are available to help control plasma phosphorus levels. Although effective at lowering serum phosphorus, they all have safety, tolerability, and compliance issues that need to be considered when selecting which one to use. Areas covered: This paper revi...
Source: Expert Opinion on Drug Safety - May 25, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Nocebo effects: more investigation is needed.
Authors: Benedetti F, Shaibani A PMID: 29768057 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 19, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Corrigendum.
Authors: PMID: 29768100 [PubMed - in process] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 19, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Expression of concern.
Authors: PMID: 29768101 [PubMed - in process] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 19, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety profile of medications used to treat Waldenstr öm's macroglobulinemia.
A safety profile of medications used to treat Waldenström's macroglobulinemia. Expert Opin Drug Saf. 2018 May 17;: Authors: García-Sanz R, Jiménez C, González de la Calle V, Sarasquete ME Abstract INTRODUCTION: Waldenström's macroglobulinemia (WM) is a B-cell lymphoproliferative disease with serum IgM monoclonal component and bone marrow infiltration by lymphoplasmacytic lymphoma. Traditional therapy was based on that regimens used for closely related entities, such as chronic lymphocytic leukemia or multiple myeloma. This resulted in a lack of drugs specifically approved...
Source: Expert Opinion on Drug Safety - May 19, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A comparison of approaches to identify possible cases of local anesthetic systemic toxicity in the FDA Adverse Event Reporting System (FAERS) database.
CONCLUSIONS: Our findings suggest the estimated incidence of possible LAST cases with LB is similar to, or less than, the reported incidence with other injectable local anesthetics. PMID: 29745266 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 12, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of trifluridine and tipiracil for the treatment of metastatic colorectal cancer.
Authors: Martinez-Perez J, Riesco-Martinez MC, Garcia-Carbonero R Abstract INTRODUCTION: TAS102 is an oral thymidine-based nucleoside analogue that has been approved for the treatment of patients with metastatic colorectal cancer (mCRC) previously treated with, or not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vascular endothelial growth factor (VEGF) agents and, if RAS wild-type, anti-epidermal growth factor receptor (EGFR) therapy. The pivotal RECOURSE phase III trial demonstrated a significant improvement in disease control rate, progre...
Source: Expert Opinion on Drug Safety - May 12, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of indacaterol for the treatment of COPD.
Authors: Metaxas EI, Balis E Abstract INTRODUCTION: Bronchodilators, namely long-acting inhaled β2-agonists and long-acting muscarinic antagonists, are the first-line medications for chronic obstructive pulmonary disease (COPD). The safety of these medicines is of great concern since COPD patients usually have other co-morbidities such as cardio- and cerebrovascular diseases. Areas covered: In this review we present information about the safety and the use of indacaterol in COPD. Indacaterol is the first once-daily, long-acting inhaled β2-agonist approved for COPD. We provide data about its mechanism of a...
Source: Expert Opinion on Drug Safety - May 10, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of dual bronchodilation on cardiovascular serious adverse events in COPD.
Authors: Rogliani P, Ora J, Matera MG, Cazzola M, Calzetta L Abstract Introduction Long-acting β2-adrenoceptor (β2-AR) agonists (LABAs) plus long-acting muscarinic antagonists (LAMAs) is the cornerstone for treating chronic obstructive pulmonary disease (COPD). LABA/LAMA combinations elicit clinical and functional synergistic interaction, and such an interaction should permit to reduce the dose of each monocomponent in the drug mixture to minimize the risk of adverse events (AEs). Overall, currently available LABA/LAMA fixed-dose combinations (FDCs) combine the drugs at the same doses of formulations desi...
Source: Expert Opinion on Drug Safety - May 3, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Letter to editor: Androgenetic alopecia; drug safety and therapeutic strategies.
Authors: Ong G, Manyak M, Lulic Z PMID: 29707969 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 2, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Response to the Letter to the Editor.
Authors: Motofei IG PMID: 29707983 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 2, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The Tolerability and Safety Profile of Patiromer: A Novel Polymer-Based Potassium Binder for the Treatment of Hyperkalemia.
Authors: Pitt B, Garza D Abstract INTRODUCTION: Hyperkalemia (HK) occurs often among patients with chronic kidney disease (CKD) and heart failure (HF) and those treated with renin-angiotensin-aldosterone system inhibitors (RAASI). Even small deviations from normal potassium levels carry increased risk of mortality. Patiromer is approved for treatment of HK and has been shown in clinical trials to reduce serum potassium among patients with HK and comorbid conditions. Areas covered: We review pooled data from two clinical trials of patiromer in patients with CKD and HK, safety of patiromer in special populations, dru...
Source: Expert Opinion on Drug Safety - April 19, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

An update on adverse drug reactions related to β-lactam antibiotics.
An update on adverse drug reactions related to β-lactam antibiotics. Expert Opin Drug Saf. 2018 Apr 10;: Authors: Vardakas KZ, Kalimeris GD, Triarides NA, Falagas ME Abstract INTRODUCTION: β-lactams have been consistently associated with the majority of drug-related adverse events. Generally, these are mild under proper dosing and judicious selection. Areas covered: Immediate hypersensitivity reactions are the most feared adverse events encountered after β-lactam administration. Emerging evidence shows that immediate reactions are not as common as previously thought. Specialist consultat...
Source: Expert Opinion on Drug Safety - April 12, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Evaluation of dystonia in children and adolescents treated with atomoxetine within the Truven MarketScan database: a retrospective cohort study.
CONCLUSION: In this large retrospective cohort study, there was no significant difference in incidence or risk of dystonia among patients treated with atomoxetine compared to stimulants. PMID: 29625537 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 9, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Does high-dose benzodiazepine abuse really produce liver toxicity? Results from a series of 201 benzodiazepine monoabusers.
CONCLUSIONS: Present data suggest that prolonged use of high-dose BZD, although very dangerous for several reasons, does not seem to produce a significant drug-induced liver injury. PMID: 29621907 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 8, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Analyzing research trends on drug safety using topic modeling.
Authors: Zou C Abstract INTRODUCTION: Published drug safety data has evolved in the past decade due to scientific and technological advances in the relevant research fields. Considering that a vast amount of scientific literature has been published in this area, it is not easy to identify the key information. Topic modeling has emerged as a powerful tool to extract meaningful information from a large volume of unstructured texts. Areas covered: We analyzed the titles and abstracts of 4347 articles in four journals dedicated to drug safety from 2007 to 2016. We applied Latent Dirichlet allocation (LDA) model to extr...
Source: Expert Opinion on Drug Safety - April 8, 2018 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research