Advocacy for better metabolic monitoring after antipsychotic initiation: based on data from a French health insurance database.
Conclusion: Antipsychotic monitoring remains dramatically insufficient. New actions involving patients, practitioners, and authorities are warranted. PMID: 33225754 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 25, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Effectiveness and sustainability of deprescribing for hospitalised older patients near end of life: a systematic review.
The objective of this review was to ascertain effectiveness and post-discharge sustainability of hospital-initiated deprescribing strategies in older people near the end of life. AREAS COVERED: The authors searched for controlled trials, with low risk of bias and measures of effectiveness post-discharge. Intervention description, duration and healthcare provider engagement were investigated for their impact on reduction of number of medications, proportions of patients prescribed inappropriate medications, returns to emergency, hospital admission and adverse events. EXPERT OPINION: Limited evidence suggests hospita...
Source: Expert Opinion on Drug Safety - November 22, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Improving the safety of intravenous iron treatments for patients with chronic kidney disease.
Authors: Kassianides X, Hazara AM, Bhandari S Abstract Introduction: Iron deficiency anemia in chronic kidney disease (CKD) is common and has prognostic, financial and quality of life implications. Intravenous (IV) iron is a key intervention for optimal management, however ongoing safety concerns exist. Area covered: The potential side effects associated with IV iron use are addressed as we review the most recent studies. Hypersensitivity reactions and true anaphylaxis are indeed rare with a greater understanding of the nature of labile iron and 'Fishbane' reactions. Hypophosphatemia appears commoner with certain I...
Source: Expert Opinion on Drug Safety - November 21, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Association between prior use of antidiabetic medication and breast cancer stage at diagnosis.
CONCLUSIONS: The association between ADM use and BC diagnostic characteristics varied based on different treatments. PMID: 33207942 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 21, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Introducing sexual dysfunction in mental care.
Authors: Gombert M, Ballester P, Segura A, Peiró AM Abstract Introduction: People with any psychiatric disorder tend to have difficulties in responding sexually. However, sexual dysfunction (SD) is usually under-recognized, even the tightly hormonal and neuronal common connexions through the brain-sex axis. Multiple sources of resistance to comprehensive SD assessment and intervention efforts persist to improve this situation. Areas covered: The present review aims to underline the feasibility to introduce SD evaluation in patients with any psychiatric disorders, evaluating the potential mutual benefits of t...
Source: Expert Opinion on Drug Safety - November 18, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Association between oseltamivir use and neuropsychiatric adverse events in influenza patients: a nationwide population-based cohort study.
Conclusions: Although the reason for the inverse association in children aged 0-9 years is unknown, oseltamivir could increase the risk of NPAEs for children or adolescents aged greater than 10 years. PMID: 33183123 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 17, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety and efficacy of P2Y12 inhibitor monotherapy in patients undergoing percutaneous coronary interventions.
Authors: Galli M, Capodanno D, Andreotti F, Crea F, Angiolillo DJ Abstract Introduction: Antiplatelet therapy represents a key strategy for the prevention of thrombotic complications in patients with both acute (ACS) and chronic coronary syndromes (CCS), particularly those undergoing percutaneous coronary intervention (PCI). In these, dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is crucial in preventing ischemic events, especially stent thrombosis. Nevertheless, DAPT is associated with a bleeding risk proportionate to its duration. Ever growing appreciation of the prognostic implications asso...
Source: Expert Opinion on Drug Safety - November 14, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Adverse drug reactions in elderly: a five-year review of spontaneous reports to the Portuguese Pharmacovigilance System.
Conclusions Most of the suspected ADRs were classified as serious. The majority of them were expected, so preventable, highlighting the importance of improving medication use in elderly. PMID: 33170742 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 12, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The reporting of observational studies of drug effectiveness and safety: recommendations to extend existing guidelines.
Authors: Cragg JJ, Azoulay L, Collins G, De Vera M, Etminan M, Lalji F, Gershon A, Guyatt G, Harrison M, Jutzeler C, Kassam R, Kendzerska T, Lynd L, Mansournia MA, Sadatsafavi M, Tong B, Warner F, Tremlett H Abstract INTRODUCTION: The use of observational data to assess drug effectiveness and safety can provide relevant information, much of which may not be feasible to obtain through randomized clinical trials. Because observational studies provide critical drug safety and effectiveness information that influences drug policy and prescribing practices, transparent, consistent, and accurate reporting of these studie...
Source: Expert Opinion on Drug Safety - November 12, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety and efficacy of anakinra as first-line or second-line therapy for systemic onset juvenile idiopathic arthritis - data from the German BIKER registry.
Conclusion: The current analysis adds to the established safety profile of anakinra and demonstrates that anakinra is effective as first-line or second-line treatment. PMID: 33148061 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - November 7, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Association of H1-antihistamines with Torsade de Pointes: a pharmacovigilance study of the Food and Drug Administration Adverse Event Reporting System.
This study aimed to measure the association of various H1-antihistamines (H1A) with TdP, and present a comprehensive overview of H1A-induced TdP cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods All H1A-induced TdP cases (n=406) were retrieved from the FAERS database using the preferred term "Torsade de Pointes" of MedDRA version-22 from 1990-2019. Four data-mining algorithms were used for disproportionality analysis: Reporting Odds Ratio (ROR); Proportional Reporting Ratio (PRR), Empirical Bayes Geometric Mean (EBGM), and Information Content (IC). H1A with>3 Td...
Source: Expert Opinion on Drug Safety - November 5, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety considerations when managing gastro-esophageal reflux disease in infants.
Authors: Vandenplas Y, Levy E, Simon M Abstract INTRODUCTION: Gastro-esophageal reflux disease (GERD) in infants is worldwide diagnosed with increasing frequency, resulting in an increasing number of infants exposed to treatment. In this review, we focus on the safety of therapeutic options. AREAS COVERED: English articles were searched from 1990 until May 2020 in PubMed and Google Scholar. Evidence suggests that non-pharmacological treatment is often effective and safe. Guidelines restrict pharmacological treatment to acid-suppressive medication, which is associated with adverse effects, often related to gastr...
Source: Expert Opinion on Drug Safety - October 30, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of medications used to treat peripheral neuropathic pain, part 2 (opioids, cannabinoids and other drugs): review of double-blind, placebo-controlled, randomized clinical trials.
Authors: Cuménal M, Selvy M, Kerckhove N, Bertin C, Morez M, Courteix C, Busserolles J, Balayssac D Abstract INTRODUCTION: Peripheral neuropathic pain is a highly disabling condition for patients and a challenge for physicians. Although many drugs have been assessed in scientific studies, few have demonstrated clear clinical efficacy against neuropathic pain. Moreover, the paucity of data regarding their safety raises the question of the benefit-risk ratio when used in patients experiencing peripheral neuropathies. AREAS COVERED: We conducted a review of double-blind, placebo-controlled, randomized clini...
Source: Expert Opinion on Drug Safety - October 28, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety of current recombinant human growth hormone treatments for adults with growth hormone deficiency and unmet needs.
Authors: Höybye C, Beck-Peccoz P, Simsek S, Zabransky M, Zouater H, Stalla G, Murray RD Abstract INTRODUCTION: Growth hormone (GH) deficiency (GHD) in adults is characterised by abnormal body composition, unfavourable cardiovascular risk factors and poor quality of life. The diagnosis is made within appropriate clinical settings and according to established guidelines. Numerous studies have shown that GH treatment improves body composition, cardiovascular risk factors, physical capacity and quality of life while issues on safety, in particular long-term safety, remain. AREAS COVERED: Short- and long-term s...
Source: Expert Opinion on Drug Safety - October 23, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Current treatment options and safety considerations when treating adult-onset Still's disease.
Authors: Cavalli G, Farina N, Campochiaro C, Baldissera E, Dagna L Abstract INTRODUCTION: . Adult onset Still disease (AOSD) is a rare systemic inflammatory condition. The clinical spectrum of this disease ranges from self-limiting forms with mild symptoms to life-threatening cases. Glucocorticoids and non-steroidal anti-inflammatory drugs (NSAIDs) represent the first line of therapy for AOSD, with add-on therapy with second-line drug reserved to steroid-dependent patients and in life-threatening cases. Currently, early treatment with conventional disease modifying anti-rheumatic drugs (DMARDs) and biologic agents ...
Source: Expert Opinion on Drug Safety - October 22, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Hedgehog inhibitors in the treatment of advanced basal cell carcinoma: risks and benefits.
Authors: Villani A, Cinelli E, Fabbrocini G, Lallas A, Scalvenzi M Abstract INTRODUCTION: Basal cell carcinoma (BCC) is the most common non melanoma skin cancer (NMSC). Although surgery is the first-line therapy for BCC, some cases can progress to an advanced or, rarely, a metastatic state and targeted therapy are required. The main pathway involved in BCC tumorigenesis is the Hedgehog (Hh) signaling pathway and its inhibition is among the few treatment options available for patients with advanced BCCs. Recent advances in targeting this pathway have led to the development of two small-molecule oral Hh inhibitors, v...
Source: Expert Opinion on Drug Safety - October 20, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety evaluation of aripiprazole in the treatment of schizophrenia.
Authors: Preda A, Shapiro BB Abstract INTRODUCTION: Aripiprazole is a third generation antipsychotic approved by the US Food and Drug Administration (FDA) for the treatment of schizophrenia. Aripiprazole is available as oral and long-acting injectable (LAI) depot formulations, with a unique mechanism of action comprising partial D2 and serotonin 5-HT1A agonism and antagonism at serotonin 5-HT2A receptors. AREAS COVERED: We review short-and-long-term clinical trials, meta-analyses of clinical trials and product information pertaining to the safety and efficacy of aripiprazole in adults with schizophren...
Source: Expert Opinion on Drug Safety - October 20, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety evaluation of current medications for adult women with the polycystic ovarian syndrome not pursuing pregnancy.
Authors: Luque-Ramírez M, Ortiz-Flores AE, Nattero-Chávez L, Escobar-Morreale HF Abstract INTRODUCTION: The polycystic ovary syndrome (PCOS) is a very prevalent disorder in premenopausal women. Cardiovascular risk factors cluster in these patients, raising concern about the safety of the drugs commonly used to ameliorate symptoms of androgen excess in these patients. AREAS COVERED: This review summarizes the clinical efficacy and safety profiles of drugs commonly used for the management of hyperandrogenic symptoms and endometrial protection in adult women with PCOS who do not seek pregnancy. E...
Source: Expert Opinion on Drug Safety - October 20, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Effects of the ABCB1 C3435T single nucleotide polymorphism on major adverse cardiovascular events in acute coronary syndrome or coronary artery disease patients undergoing percutaneous coronary intervention and treated with clopidogrel: A systematic review and meta-analysis.
This study examined the pooled risk of major adverse cardiovascular events (MACE) and bleeding events associated with the ABCB1 C3435T polymorphism in acute coronary syndrome or coronary artery disease patients undergoing PCI and treated with clopidogrel. AREAS COVERED: Literature was searched in different resources for eligible studies. The pooled risk ratio was measured using RevMan software, with p
Source: Expert Opinion on Drug Safety - October 15, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Statins in liver cirrhosis in a developing country: benefits overweigh the risk?
Authors: Gonzáles Yovera JG, Concepción-Zavaleta MJ, Moreno Marreros DM, Armas Flórez CD PMID: 33047634 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - October 15, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety implications of combining ACE inhibitors with thiazides for the treatment of hypertensive patients.
Authors: Borghi C, Soldati M, Bragagni A, Cicero AFG Abstract INTRODUCTION: ACE-inhibitors (ACEI) and diuretics are the typical first-line antihypertensive drugs with complementary mechanisms of action. The present paper is summarizing the evidence supporting the efficacy of their combination in a broad range of hypertensive patients. AREAS COVERED: This source of data are different trials investigating the use of ACEI and diuretics in different populations of patients. The available evidence supports some advantage for thiazide-type compounds (chlortalidone-CHT and indapamide-IND) in the prevention of major CV...
Source: Expert Opinion on Drug Safety - October 15, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Statins-induced hepatotoxicity: Still more questions than answers.
Authors: Mulchandani R, Lyngdoh T, Kakkar AK PMID: 33031710 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - October 9, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Selective serotonin reuptake inhibitors and the risk of congenital anomalies anomalies: a systematic review of current meta-analyses.
CONCLUSION: Further large-scale prospective observational studies and meta-analyses on the effects of individual SSRIs other than paroxetine, especially escitalopram and fluvoxamine, are required to reach definitive conclusions. PMID: 33001713 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - October 3, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Frequency of real-world reported adverse drug reactions in rheumatoid arthritis patients.
CONCLUSIONS: . Although ADR data in the DREAM-RA registry were partly comparable with data in the SmPCs, RWD from this patient registry provided an added value to the currently available information on the incidences of ADRs associated with DMARDs in RA patients as described in SmPCs. PMID: 32990050 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 30, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety of current therapies for onychomycosis.
Authors: Ricardo JW, Lipner SR Abstract INTRODUCTION: Onychomycosis is the most common nail disease seen in clinical practice. Treatment options include systemic and topical therapies, as well as devices. Following clinical and mycologic diagnosis, treatment must be individualized, accounting for disease severity, infecting organism(s), comorbidities, patient characteristics and drug/device efficacy. Safety is the most important consideration in choosing the most appropriate therapeutic modality. AREAS COVERED: This review covers currently available treatments for onychomycosis, with an emphasis on safety and t...
Source: Expert Opinion on Drug Safety - September 30, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Impact of the COVID-19 pandemic on clinical trials with drugs.
Authors: Hasford J PMID: 32970481 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - September 26, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Current and emerging fixed combination therapies in glaucoma: a safety and tolerability review.
Authors: Konstas AG, Schmetterer L, Costa VP, Holló G, Katsanos A, Denis P, Quaranta L, Irkec M, Castejón MA, Teus MA, Robin AL Abstract INTRODUCTION: Fixed dose combinations (FCs) represent a potentially valuable treatment strategy in glaucoma management. Fixed combinations not only improve adherence by reducing the medication burden, but also decrease the total amount of potentially deleterious preservatives an eye is exposed to. AREAS COVERED: We provide a critical review of selected evidence on both the safety and tolerability of presently available and emerging glaucoma FCs. There is convinci...
Source: Expert Opinion on Drug Safety - September 23, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety review of drugs used for the treatment of retinopathy of prematurity.
Authors: Filippi L, Dal Monte M Abstract INTRODUCTION: Retinopathy of Prematurity (ROP) is a sight-threatening disease representing one of the main disabling diseases affecting premature newborns. Presently, ROP is treated by surgical interventions and drug therapies are limited to the off-label use of a little amount of molecules approved for other pathologies. AREAS COVERED: Many drugs that may potentially be used in treating ROP are recently proposed, in many cases after the demonstration of their effectiveness in preclinical studies. In this review, the authors discuss safety and effectiveness of the main p...
Source: Expert Opinion on Drug Safety - September 23, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of available chemo-free treatments for mantle cell lymphoma.
This article reviews the safety profiles of new therapeutic chemotherapy-free options for MCL patients. Publications in English from 2010 through June 2020 were surveyed on the MEDLINE database for articles. Proceedings of the American Society of Hematology during the last five years were also included. EXPERT OPINION: MCL is a clinically heterogenous diseases predominantly affecting elderly patients. Its variable clinical course requires personalization and individualization of treatment to achieve optimal survival and acceptable safety profiles, especially in poor prognosis patients. Results of clinical trials perfor...
Source: Expert Opinion on Drug Safety - September 20, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety and tolerability of antipsychotic agents in neurodevelopmental disorders: a systematic review.
Authors: Iasevoli F, Barone A, Buonaguro EF, Vellucci L, de Bartolomeis A Abstract INTRODUCTION: Neurodevelopmental disorders (NDDs) are a group of complex and heterogeneous disorders, caused by the disruption of normal brain development. Antipsychotic agents are frequently used in these disorders to treat maladaptive conduct. However, a systematic evaluation of their safety/tolerability in NDDs is still lacking. Given the unique neurobiology of NDDs, antipsychotics may be expected to elicit distinctive side effects. AREAS COVERED: PubMed was systematically searched for all published studies from 1980 until 202...
Source: Expert Opinion on Drug Safety - September 9, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Intravenous vs intravenous plus aerosolized colistin for treatment of ventilator-associated pneumonia - a matched case-control study in neonates.
Authors: Hussain K, Salat MS, Ambreen G, Mughal A, Idrees S, Sohail M, Iqbal J Abstract BACKGROUND: Recently intravenous (IV) and aerosolized (ASZ) colistin have been used for treating ventilator-associated pneumonia (VAP) due to colistin susceptible multidrug-resistant Gram-negative bacteria (MDR-GNB). Colistin has limited lung penetration. We compared the efficacy and safety of IV-alone versus IV+ASZ-colistin for treating VAP in neonates. METHODS: This retrospective matched case-control-study was performed at NICU of the Aga Khan University Hospital, Pakistan between January 2015 and December 2018. Sixteen ne...
Source: Expert Opinion on Drug Safety - September 9, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The 'collateral side' of mood stabilizers: safety and evidence-based strategies for managing side effects.
Authors: Orsolini L, Pompili S, Volpe U Abstract INTRODUCTION: Adverse events (AEs) monitoring of mood stabilizers (MS) is essential during the treatment of mood disorders as safety and tolerability profiles of MS may greatly influence treatment adherence, patient's compliance and discontinuation rate. Therefore, clinicians should be aware of their AEs profile and tapering a variety of strategies to manage them, according to an evidence-based approach. AREAS COVERED: We aimed at critically summarizing the tolerability and safety profile for each non-antipsychotic MS, providing evidence-based strategies able to ...
Source: Expert Opinion on Drug Safety - September 9, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety of systemic treatments for Beh ├žet's syndrome.
Safety of systemic treatments for Behçet's syndrome. Expert Opin Drug Saf. 2020 Sep 04;: Authors: Lopalco G, Rigante D, Lopalco A, Emmi G, Venerito V, Vitale A, Capozio G, Denora N, Cantarini L, Iannone F Abstract INTRODUCTION: Treatment of Behçet's syndrome (BS) is aimed at controlling all symptoms of such a complex disorder, ensuring a good quality of life and preventing life-threatening complications. A better understanding of the pathogenic role of different chemokines has improved our knowledge of BS and elicited a more specific use of therapies currently available, minimizing the bu...
Source: Expert Opinion on Drug Safety - September 6, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety considerations when using non-ergot dopamine agonists to treat Parkinson's disease.
Authors: Stocchi F, Fossati B, Torti M Abstract INTRODUCTION: Non ergot dopamine agonists (NEDA) represent an excellent treatment option for Parkinson's disease (PD) patients, in both early and advanced stages of the disease. The post-marketing phase of NEDA has highlighted, though, the occurrence of important long-term adverse events. AREAS COVERED: This review reports recent updates on NEDA adverse events, analysing neurobiological bases and risk factors of these complications. A literature search has been performed using Medline and reviewing the bibliographies of selected articles. EXPERT OPINION: NEDA ...
Source: Expert Opinion on Drug Safety - September 3, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The cognitive safety of antimuscarinics in the treatment of overactive bladder.
Authors: Araklitis G, Robinson D Abstract INTRODUCTION: Overactive bladder is a common problem women suffer from, with its incidence increasing with age. The mainstay of treatment is antimuscarinic medication. There is growing evidence that antimuscarinics may increase the risk of cognitive impairment, dementia and even death. Areas covered: This review explores the evidence that antimuscarinics increase the risk of cognitive impairment, dementia and death. It evaluates how best to treat overactive bladder the older woman. Expert opinion: The evidence suggests that antimuscarinics increase the risk of cognitive imp...
Source: Expert Opinion on Drug Safety - August 30, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety and efficacy evaluation of encorafenib plus binimetinib for the treatment of advanced BRAF-mutant melanoma patients.
Authors: Indini A, Mandalà M Abstract INTRODUCTION: Approximately 40-50% of patients with cutaneous melanoma harbour point mutations in BRAF. BRAF and MEK inhibitors in combination are now a standard therapy for advanced BRAF V600-mutated melanoma. Nevertheless, survival rates with the combination are limited, highlighting the need for further therapeutic improvement and strategies to overcome primary and acquired resistance. AREAS COVERED: Encorafenib, a highly selective BRAF inhibitor, was developed in combination with binimetinib, a potent, selective allosteric MEK1/2 inhibitor, to improve efficacy an...
Source: Expert Opinion on Drug Safety - August 30, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Baricitinib, JAK inhibitors and liver injury: a cause for concern in COVID-19?
Authors: Raschi E, Caraceni P, Poluzzi E, De Ponti F PMID: 32840116 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - August 27, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

CGRP inhibitors for migraine prophylaxis: a safety review.
Authors: Rivera-Mancilla E, Villalón CM, MaassenVanDenBrink A Abstract INTRODUCTION: Since calcitonin gene-related peptide (CGRP) plays an important role in the pathophysiology of migraine via the activation of the trigeminovascular system, the newest prophylactic treatments directly block CGRP or its receptor. However, the safety of these novel antimigraine drugs is not yet sufficiently established. AREAS COVERED: Based on the blockade of CGRP or its receptor, this review considers: (i) the effects of the novel prophylactic antimigraine drugs (i.e. gepants and monoclonal antibodies) in clinical trials; ...
Source: Expert Opinion on Drug Safety - August 21, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety profile of ocrelizumab for the treatment of multiple sclerosis: a systematic review.
Authors: Ng HS, Rosenbult CL, Tremlett H Abstract INTRODUCTION: We systematically collated and reviewed reported adverse events (AEs) for ocrelizumab for multiple sclerosis (MS). Areas covered: We searched Medline, Embase, Web of Science and Toxicology Data Network-TOXLINE from inception to 08-July-2020, and clinical trial registries, and product monographs for any clinical trials, observational studies or case reports examining AEs to ocrelizumab in person(s) with MS. Studies with/without a comparator drug or placebo were eligible. Expert opinion: Overall, 78 records were included (4 randomized controlled trials (...
Source: Expert Opinion on Drug Safety - August 18, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

New and emerging cardiovascular and antihypertensive drugs.
Authors: Chrysant SG, Chrysant GS Abstract INTRODUCTION: Hypertension and cardiovascular diseases (CVD) are very common conditions and account for significant medical disability and death worldwide. Therefore, their successful management is very critical for the prevention of the significant cardiovascular and socioeconomic consequences arising from their poor management. Areas Covered: Although we have several effective cardiovascular (CV) drugs for their treatment, they are not all completely successful for the effective management of CVD and hypertension. Thus, the need for the discovery and development of new d...
Source: Expert Opinion on Drug Safety - August 18, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety evaluation of immune-based combinations in patients with advanced renal cell carcinoma: a systematic review and meta-analysis.
Authors: Massari F, Mollica V, Rizzo A, Cosmai L, Rizzo M, Porta C Abstract Introduction Immune-based combinations, including nivolumab plus ipilimumab, pembrolizumab plus axitinib, and (at a lesser extent) avelumab plus axitinib, should be regarded among the new standards of care for first line therapy of metastatic renal cell carcinoma. Toxicity profiles are different among all these above combinations, as well as between them and targeted agents monotherapies, including sunitinib (i.e. the control arm of all the above studies). Areas covered We performed a systematic review and meta-analysis with the aim to comp...
Source: Expert Opinion on Drug Safety - August 18, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety of pembrolizumab for resected stage III melanoma.
Authors: Pham F, Dalle S Abstract Introduction Patients with resected stage III melanoma have a heterogeneous prognosis with an especially high risk of relapse for patients with stage IIIB, IIIC and IIID according to the 2018 classification in AJCC Cancer Staging Manual, 8th edition (AJCC-8). Ipilimumab was the first immune checkpoint inhibitor (ICI) to show prolonged overall survival (OS) but at the cost of high toxicity. Pembrolizumab and nivolumab are inhibitors of programmed cell death 1 (PD-1) and showed prolonged relapse-free survival (RFS) in patients with resected stage III melanoma at high risk of relapse ...
Source: Expert Opinion on Drug Safety - August 18, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Reply to letter to the editor: Baricitinib and toxicity is a rare occurrence.
Authors: Peng L, Stebbing J, Wang YJ PMID: 32804556 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - August 18, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

An update on hip fracture risk associated with anticoagulant therapy: warfarin versus direct oral anticoagulants.
Authors: Sugiyama T PMID: 32795203 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - August 17, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Anticholinergic medications and risk of dementia in older adults: where are we now?
Authors: Chatterjee S, Talwar A, Aparasu RR Abstract INTRODUCTION: Anticholinergic medications are effective for a wide variety of indications, but are associated with significant central adverse effects, especially cognitive decline and dementia in older adults. AREAS COVERED: We conducted a review of relevant literature in the past decade to address anticholinergic scales and evidence of anticholinergic-related dementia/cognitive decline in older adults. We discussed various anticholinergic scales used to classify anticholinergic medications. The review focused on the evidence from previous reviews and indivi...
Source: Expert Opinion on Drug Safety - August 17, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The risk of cardiovascular complications with current obesity drugs.
Authors: Chao AM, Wadden TA, Berkowitz RI, Quigley K, Silvestry F Abstract INTRODUCTION: Obesity is associated with an increased risk of cardiovascular morbidity and mortality. Four medications are approved by the US Food and Drug Administration (FDA) for chronic weight management when used as an adjunct to a reduced-calorie diet and increased physical activity in adults. These medications result in clinically significant weight losses, as well as improvements in some cardiometabolic risk factors. AREAS COVERED: We briefly review the history of anti-obesity medications (AOMs) as related to cardiovascular safety...
Source: Expert Opinion on Drug Safety - August 13, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Interventions to improve spontaneous adverse drug reaction reporting by healthcare professionals and patients: systematic review and meta-analysis.
Authors: Paudyal V, Al-Hamid A, Bowen M, Hadi MA, Hasan SS, Jalal Z, Stewart D Abstract INTRODUCTION: The aim of this study was to evaluate the effectiveness of interventions used for improving ADR reporting by patients and healthcare professionals. AREAS COVERED: A systematic review of literature was conducted by searching Medline, Embase and Cochrane Central Register of Controlled of Trials. Meta-analysis of randomised controlled trials (RCTs; n=5) was conducted to estimate the pooled risk ratio for the effectiveness of interventions on ADR reporting rates. Data from observational studies were synthesised usi...
Source: Expert Opinion on Drug Safety - August 13, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Possible effects of excipients used in the parenteral drugs administered in critically ill adults, children and neonates.
CONCLUSION: Critically ill neonates and children are likely to receive a significantly greater quantity of harmful excipients than critically ill adults. Benzyl alcohol and propylene glycol exposure are likely to be associated with increased risk of mortality in critically ill. PMID: 32767900 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - August 13, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety of pembrolizumab in recurrent or advanced gastric cancer expressing PD-L1 refractory to platinum and fluoropyrimidine.
Authors: Mishima S, Kawazoe A, Shitara K Abstract INTRODUCTION: Pembrolizumab is a highly selective fully human immunoglobulin 4 monoclonal antibody against programmed death 1 (PD-1). Phase II and III trials have demonstrated that pembrolizumab has antitumor activity in previously treated patients with advanced gastric cancer (AGC). AREA COVERED: Pembrolizumab was approved by the US Food and Drug Administration in September 2017 as third-line or later treatment of AGC in patients positive for programmed death ligand 1 (PD-L1). In this article, we review the development of pembrolizumab, its pharmacology, and it...
Source: Expert Opinion on Drug Safety - August 4, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Long-term drug treatment in multiple sclerosis: safety success and concerns.
Authors: Jakimovski D, Vaughn CB, Eckert S, Zivadinov R, Weinstock-Guttman B Abstract INTRODUCTION: The portfolio of multiple sclerosis (MS) disease modifying treatments (DMTs) has significantly expanded over the past two decades. Given the life-long use of MS pharmacotherapy, understanding their long-term safety profiles is essential in determining suitable and personalized MS treatment. AREAS COVERED: In this narrative review, we summarize the short-, mid- and long-term safety profile of all currently available MS DMTs categories. In addition to the initial trial findings, safety outcomes derived from long-te...
Source: Expert Opinion on Drug Safety - August 4, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research