Safety evaluation of pembrolizumab for treating recurrent head and neck squamous cell carcinoma.
Authors: Desilets A, Soulières D Abstract INTRODUCTION: Programmed death 1 (PD-1) blockade has changed the therapeutic landscape of recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) with convincing overall response rates and overall survival benefits when compared to chemotherapy alone. The toxicity profile of pembrolizumab appears to be similar to that of other PD-1 or PD-L1 inhibitors, with frequent diarrhoea, hypothyroidism or cutaneous rash cases, and rare cases of grade 3 to 5 pneumonitis.Areas covered: In this article, the pharmacokinetics and mechanism of action of pembrolizuma...
Source: Expert Opinion on Drug Safety - May 29, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Long-term safety of approved biologics for ulcerative colitis.
Authors: D'Amico F, Parigi TL, Bonovas S, Peyrin-Biroulet L, Danese S Abstract INTRODUCTION: Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) affecting the large intestine and carrying a heavy burden of morbidity for patients. Conventional treatment is based on mesalamine, corticosteroids, and immunosuppressants. In the last two decades, biologic therapies have revolutionized the treatment of UC, increasing the number of therapeutic options and providing better disease control. AREAS COVERED: Most biologics have been approved in recent years and long-term data are still scarce. The aim of t...
Source: Expert Opinion on Drug Safety - May 23, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

SARS-CoV-2, from its current highly contagious spreading towards the global development of an effective and safe vaccine: challenges and uncertainties.
Authors: Merante D PMID: 32442040 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 23, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Letter to the Editor: Consideration on "An evaluation of reports of ciprofloxacin, levofloxacin, and moxifloxacin- association neuropsychiatric toxicities, long-term disability, and aortic aneurysms/dissections disseminated by the Food and Drug Administration and the European Medicines Agency" by Bennett et al.
Letter to the Editor: Consideration on "An evaluation of reports of ciprofloxacin, levofloxacin, and moxifloxacin- association neuropsychiatric toxicities, long-term disability, and aortic aneurysms/dissections disseminated by the Food and Drug Administration and the European Medicines Agency" by Bennett et al. Expert Opin Drug Saf. 2020 May 19;:1-2 Authors: Monti M, Silimbani P, Ruscelli S, Frassineti GL PMID: 32427001 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 21, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety of injectable semaglutide for type 2 diabetes.
Authors: Peter R, Bain SC Abstract Introduction: Semaglutide is the most recently approved injectable glucagon-like peptide-1 receptor agonist (GLP-1RA) for people with type 2 diabetes (T2DM). It is one of three currently marketed GLP-1RAs that can be administered once weekly.Areas covered: This review focusses on the safety of injectable semaglutide. Semaglutide has been assessed in the SUSTAIN phase 3 clinical trial programme, which included patients across the disease spectrum i.e. treatment-naïve to those receiving insulin. The authors have looked at all published literature on safety considerations of onc...
Source: Expert Opinion on Drug Safety - May 21, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Psychotropic drug concentrations and clinical outcomes in children and adolescents: a systematic review.
Authors: Kloosterboer SM, Vierhout D, Stojanova J, Egberts KM, Gerlach M, Dieleman GC, Hillegers MHJ, Passe KM, Gelder TV, Dierckx B, Koch BCP Abstract Introduction: The use of psychotropic drugs in children and adolescents is widespread but associated with suboptimal treatment effects. Therapeutic drug monitoring (TDM) can improve safety of psychotropic drugs in children and adolescents, but is not routinely performed. A major reason is that the relationship between drug concentrations and effects is not well known.Areas covered: This systematic review evaluated studies assessing the relationship between psychotro...
Source: Expert Opinion on Drug Safety - May 19, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Adverse drug reactions in adolescents: A review of reporting to a National Pharmacovigilance System.
Conclusion: Major findings considering drugs involved and the reported reactions varied according to age and sex. PMID: 32422079 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 19, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety evaluations of adalimumab for childhood chronic rheumatic diseases.
Authors: Maccora I, dell'Anna MP, Vannacci A, Simonini G Abstract Introduction: Childhood rheumatic diseases (CRD) are chronic inflammatory conditions, often leading to severe functional impairment and disability. They produce high direct and indirect costs for patients, their families and society overall. Biologic treatment, adalimumab of note, has drastically changed the disease management, significantly decreasing morbidity, over childhood, and eventually lifelong. After 12 years of pediatric experience with adalimumab, safety data resulted of great interest.Areas covered: This review summarizes published knowle...
Source: Expert Opinion on Drug Safety - May 16, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of atezolizumab plus chemotherapy for the treatment of metastatic lung cancer.
Authors: Manzo A, Carillio G, Montanino A, Sforza V, Palumbo G, Esposito G, Costanzo R, Sandomenico C, La Manna C, Martucci N, La Rocca A, De Luca G, Piccirillo MC, De Cecio R, Botti G, Totaro G, Muto P, Picone C, Normanno N, Morabito A Abstract Introduction: Atezolizumab is a humanized monoclonal antibody against PD-L1 capable of enhancing antitumor immune activity, with a demonstrated activity as single agent in patients with advanced non-small-cell lung cancer (NSCLC).Areas covered: This review summarizes the clinical data emerging from randomized clinical studies with atezolizumab in NSCLC and small-cell lung c...
Source: Expert Opinion on Drug Safety - May 15, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Concerns about the safety of anti-TNF agents when treating rheumatic diseases.
Authors: Atzeni F, Nucera V, Gerratana E, Cirillo M, Marino F, Miceli G, Sangari D, Boccassini L, Masala IF Abstract Introduction: More than 15 years after its introduction, there is still no agreement as to whether anti-TNF treatment increases the risk of developing infections, cardiovascular or neurological diseases, or auto-antibodies. Anti-TNF drugs reduce inflammation and sub-clinical atherosclerosis in rheumatoid arthritis (RA) patients, but they also alter their lipid profiles and can lead to the development of severe infections. Furthermore, as they increase the risk of developing demyelinating disease...
Source: Expert Opinion on Drug Safety - May 15, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Targeted therapies for autoimmune/idiopathic non-malignant diseases: risk and management of opportunistic infections.
Authors: Bavaro DF, Fiordelisi D, Angarano G, Monno L, Saracino A Abstract Introduction: The management of patients affected by autoimmune/idiopathic diseases has been revolutionized by the development of targeted therapies (TT). However, the use of TT is complicated by several adverse events, like opportunistic infections (OIs). The potential of TT to predispose to OIs mainly depends on site of action, nevertheless, such associations are far from being deterministic, because many factors could increase the infection risk.Areas covered: The impact on infective risk of different TT used for autoimmune/idiopathic dis...
Source: Expert Opinion on Drug Safety - May 13, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Towards digital-based interventions for medication adherence and safety.
Authors: Haga SB Abstract Introduction: Adherence to the prescribed use of medications is a major problem for many patients. Whether intentional or unintentional, the failure to take medications as prescribed results in an array of health problems, hospitalizations, and increased health expenditures.Areas covered: The paper reviews the different types of interventions to promote the appropriate use of medications from provider-based to digital-based interventions. These interventions often combine passive and interactive approaches and may include bio-surveillance/monitoring. Many studies have evaluated these inter...
Source: Expert Opinion on Drug Safety - May 8, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Drug-induced retroperitoneal fibrosis: a case/non-case study in the French PharmacoVigilance Database.
Conclusion: This study confirmed an association between RPF and derivatives of ergot alkaloids. These data represent a pharmacovigilance signal despite the limits of the case/non-case method (underreporting, confounding factors, etc.). Indeed, a significant signal was found with drugs less known (TNF-α antagonists) or not known (some hypnotics, antiepileptic drugs, antipsychotics, anxiolytics and antidepressants) to induce such an adverse drug reaction (ADR). Finally, these data could contribute to realize prospective studies to confirm these signals. PMID: 32374194 [PubMed - as supplied by publisher] (Source: Ex...
Source: Expert Opinion on Drug Safety - May 8, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of medications used to treat peripheral neuropathic pain, part 1 (antidepressants and antiepileptics): review of double-blind, placebo-controlled, randomized clinical trials.
Authors: Selvy M, Cuménal M, Kerckhove N, Courteix C, Busserolles J, Balayssac D Abstract Introduction: Peripheral neuropathic pain is highly disabling conditions for patients and a challenge for neurologists and pain physicians. Although many drugs have been assessed in scientific studies, few have demonstrated a clear clinical efficacy against neuropathic pain. Moreover, the paucity of data regarding their safety raised the question on the benefit-risk ratio when used in patients experiencing peripheral neuropathies.Areas covered: The authors conducted a review of double-blind, placebo-controlled, randomiz...
Source: Expert Opinion on Drug Safety - May 6, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Response to: Letter to the Editor: Consideration on "An evaluation of reports of ciprofloxacin, levofloxacin, and moxifloxacin association neuropsychiatric toxicities, long-term disability, and aortic aneurysms/dissections disseminated by the Food and Drug Administration and the European Medicines Agency" by Bennett et al.
Response to: Letter to the Editor: Consideration on "An evaluation of reports of ciprofloxacin, levofloxacin, and moxifloxacin association neuropsychiatric toxicities, long-term disability, and aortic aneurysms/dissections disseminated by the Food and Drug Administration and the European Medicines Agency" by Bennett et al. Expert Opin Drug Saf. 2020 May 04;: Authors: Bennett AC, Bennett CL, Witherspoon BJ PMID: 32364807 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 6, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety evaluation of durvalumab for the treatment of non-small-cell lung cancer.
Authors: Shibata Y, Murakami S Abstract Introduction: The development of immune checkpoint inhibitors (ICIs), such as anti-programmed death 1/programmed death ligand 1 (PD-1/PD-L1) inhibitors, has been a breakthrough in the treatment of non-small-cell lung cancer (NSCLC). Durvalumab, a PD-L1 inhibitor, has shown survival benefit as a maintenance therapy for patients with unresectable stage III NSCLC following definitive chemoradiotherapy, and is approved by the U.S. Food and Drug Administration and the European Medicines Agency.Areas covered: In this article, we review the development of durvalumab, its pharmacolog...
Source: Expert Opinion on Drug Safety - May 4, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Nothing is perfect: the safety issues of integrase inhibitor regimens.
Authors: Scévola S, Tiraboschi JM, Podzamczer D Abstract Introduction: Since the administration of the first integrase strand transfer inhibitor (INSTI) in 2007, most international treatment guidelines consider INSTI-based regimens to be the preferred antiretroviral combinations for HIV-1-infected patients as a result of their safety and efficacy profile. INSTIs are generally well tolerated, and reported rates of discontinuation due to drug-related adverse events (AEs) have been very low to date. However, recent reports indicate that physicians should be aware of potential INSTI-related AEs to ensure good cl...
Source: Expert Opinion on Drug Safety - May 2, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Adverse events related to topical drug treatments for acne vulgaris.
Authors: Otlewska A, Baran W, Batycka-Baran A Abstract Introduction: Acne vulgaris is a widespread skin disease. Topical therapy is a standard treatment for mild to moderate acne. Given the complex pathophysiology of acne, various agents with complementary action are nowadays frequently combined to increase the efficacy of therapy.Area covered: This review focus on safety profile of topical agents used for the treatment of acne vulgaris, including topical retinoids, benzyl peroxide, azelaic acid, topical antibiotic, and combined agents. Data from clinical trials but also metanalyses, systematic reviews, and other s...
Source: Expert Opinion on Drug Safety - May 1, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety and efficacy of idursulfase in the treatment of mucopolysaccharidosis II (Hunter syndrome): a post-marketing study in Japan.
Conclusion: Long-term idursulfase treatment was well tolerated, and effective in improving clinical features, reducing urinary UA, and slowing disease progression in Japanese MPS II patients. PMID: 32342708 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 29, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

An update on the safety of nivolumab for the treatment of advanced melanoma.
Authors: Czarnecka AM, Rutkowski P Abstract Introduction: Due to its unique mechanism of action as an immune checkpoint inhibitor, nivolumab has high antitumor activity, but at the same time this mechanism is responsible for immune-related adverse events that may limit patients' safety and therapy continuation.Areas covered: Long term safety of nivolumab including 5-year follow-up, safety of nivolumab treatment after ipilimumab therapy, safety of nivolumab in challenging subgroups (elderly, patients with brain metastases, patients with autoimmune disorders), safety of nivolumab in with rare melanoma subtypes (inclu...
Source: Expert Opinion on Drug Safety - April 16, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety of EGFR-TKIs for EGFR mutation-positive non-small cell lung cancer.
Authors: Zhou JY, Liu SY, Wu YL Abstract Introduction: Lung cancer is the most prevalent malignant tumors worldwide. Over the past decade, the emergence of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) has ushered in a new era of lung cancer treatment. Therefore, clinical trials investigating the efficacy and safety of these drugs are important.Areas covered: This review provides an overview on the safety of three classes of EGFR-TKIs and discusses the adverse events (AEs) and reactions reported in the literature.Expert opinion: EGFR-TKIs significantly improve progression-free survival and...
Source: Expert Opinion on Drug Safety - April 9, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Adalimumab in children and adolescents with severe plaque psoriasis: a safety evaluation.
Authors: Zangrilli A, Bavetta M, Bianchi L Abstract Introduction: Psoriasis is a chronic inflammatory systemic disease that affects 2% of the population and is associated with an important physical and physiological burden. About 0,5-2% of psoriatic cases onset during the pediatric age range, and often it's not diagnosed until adulthood. Adalimumab is an anti-tumor necrosis factor monoclonal antibody approved for use in children in 2008 and now it was used in several diseases in rheumatology, gastroenterology and in dermatology.Areas covered: The purpose of this article was to summarize what has been described in t...
Source: Expert Opinion on Drug Safety - April 8, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Measuring drug burden in older adults with Intellectual Disabilities: Critical issues for consideration in finding the optimal measure to improve safety of medicines use.
Authors: O'Dwyer M, McCallion P, McCarron M, O'Connell J, Henman M PMID: 32241202 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 5, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety of calcipotriene and betamethasone dipropionate foam for the treatment of psoriasis.
Authors: Amat-Samaranch V, Puig L Abstract Introduction: Psoriasis vulgaris is a chronic inflammatory skin disease characterized by well-demarcated red and scaly plaques. Most patients have mild disease that is usually controlled with topical treatment. Calcipotriene 0.05% and betamethasone dipropionate 0.064% (Cal/BD) in aerosol foam (Enstilar®) is a novel formulation, which has shown promising results in terms of efficacy and safety.Areas covered: This review evaluates the safety profile of Cal/BD aerosol foam and also the key points regarding to its efficacy. A literature search was performed in PubMed on No...
Source: Expert Opinion on Drug Safety - April 5, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

An overview of statin-induced myopathy and perspectives for the future.
Authors: Nikolic D, Banach M, Chianetta R, Luzzu LM, Pantea Stoian A, Diaconu CC, Citarrella R, Montalto G, Rizzo M Abstract Introduction: Statins remain the most commonly prescribed lipid-lowering drug class for the treatment of atherosclerotic cardiovascular disease. Their well-recognized side effects are known as statin-associated muscle symptom (SAMS). Some advances in this field have been made in recent years, but the understanding of the mechanisms has lagged. Investigating the specific role of the anti-HMGCR autoantibody, pharmacokinetic genetic variants, characterization of the known phenotypes of statin to...
Source: Expert Opinion on Drug Safety - April 4, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of antimicrobials for the treatment of community-acquired pneumonia.
Authors: Bastida C, Soy D, Torres A Abstract Introduction: Community-acquired pneumonia (CAP) is a leading cause of morbidity and mortality worldwide, and its prevalence continues to increase. Despite the efficacy of antimicrobials, their safety and tolerability remain topics of interest and concern for clinicians and patients alike.Areas covered: This review outlines the main antimicrobial classes recommended for the empirical treatment of CAP in current guidelines, together with a potential new class. Each pharmacological group underwent a safety evaluation based on all available data about drug-related toxicitie...
Source: Expert Opinion on Drug Safety - April 4, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety of antithyroid drugs in pregnancy: update and therapy implications.
Authors: Francis T, Francis N, Lazarus JH, Okosieme OE Abstract Introduction: The thionamide antithyroid drugs, methimazole (MMI), its pro-drug derivative carbimazole (CMZ), and propylthiouracil (PTU) are the mainstay of treatment for hyperthyroidism in pregnancy. However, antithyroid drugs carry risks of adverse effects that can affect fetal and maternal well-being.Areas covered: This review provides an update on the safety of antithyroid drugs in pregnancy, focusing on the most serious concerns of severe liver disease and congenital anomalies.Expert opinion: PTU-induced liver disease is uncommon but can run a cat...
Source: Expert Opinion on Drug Safety - April 2, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Cardiovascular safety and effectiveness of vildagliptin in patients with type 2 diabetes mellitus: a 3-year, large-scale post-marketing surveillance in Japan.
Authors: Ishida Y, Murayama H, Shinfuku Y, Taniguchi T, Sasajima T, Oyama N Abstract Objectives: The dipeptidyl peptidase-4 (DPP-4) inhibitor vildagliptin is indicated for type 2 diabetes mellitus (T2DM). However, the long-term safety, effectiveness, and clinical relationship with cardiovascular events of vildagliptin have not been evaluated in Japan.Methods: The authors conducted post-marketing surveillance (PMS) to evaluate the safety and effectiveness of vildagliptin in more than 3000 Japanese T2DM patients for up to 3 years. Main assessments included demographics, major adverse cardiovascular events (MACE)...
Source: Expert Opinion on Drug Safety - April 2, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

How is safety of dermatology drugs assessed: trials, registries, and spontaneous reporting.
Authors: Asfour L, Yiu ZZN, Warren RB Abstract Introduction: Skin conditions are common and highly varied in their etiology; therefore, a diverse array of therapeutics are utilized. Drug safety studies in dermatology can be challenging as there are over 3000 diagnoses to consider. As a result, dermatologists rely on data from multiple sources including clinical trials and real-world evidence.Areas covered: In this review, we cover the main sources of safety data available, their strengths and weaknesses and how dermatologists should utilize such data. We use real-world examples of the different types of adverse eve...
Source: Expert Opinion on Drug Safety - April 2, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Effect of the black triangle scheme and its online educational campaign on the quantity and quality of adverse drug event reporting in Australia: a time series analysis.
Authors: Li R, Curtis K, Zaidi STR, Van C, Castelino R Abstract Objectives: The black triangle scheme was introduced to Australia in January 2018 to improve the significant under-reporting of adverse drug events (ADEs) in Australia. The authors investigated the impact of the black triangle scheme on the quantity and quality of ADE reports submitted to the Therapeutic Goods Administration.Methods: An interrupted time series analysis with segmented regression was conducted to compare the quantity of ADE reports pre and post the black triangle intervention for the period between January 2017 and December 2018. The qua...
Source: Expert Opinion on Drug Safety - March 26, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A description of medicines related safety issues evaluated through a referral procedure at the EU level after 2012.
Conclusions: PRAC recommended routine or additional RMMs for most referrals. Complete withdrawal of a drug or withdrawal of certain pharmaceutical forms or concentrations was advised only when the risk could not be managed by RMMs. PMID: 32186202 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 20, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The relationship between atypical antipsychotics drugs and cardiac arrhythmias: implications for clinical use.
Authors: Ruiz Diaz JC, Frenkel D, Aronow WS Abstract Introduction: Increased mortality has been observed in patients with mental health disorders. Specifically, exposure to antipsychotic medications conveys a greater than 2 fold risk of sudden death, thought to be mediated through effects on QT prolongation and risk of torsades de pointes.Areas Covered: Authors review the association between antipsychotic drugs and sudden cardiac death, the physiologic basis for these associations, assessment of patients at risk, and strategies to minimize risk of sudden cardiac death.Expert Opinion: Despite the prevalence of antip...
Source: Expert Opinion on Drug Safety - March 20, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety update of etanercept treatment for moderate to severe plaque psoriasis.
Authors: Campanati A, Diotallevi F, Martina E, Paolinelli M, Radi G, Offidani A Abstract Introduction: Conventional topical therapies and disease-modifying anti-rheumatic drugs (DMARDs) for patients with psoriasis are often linked to inadequate outcomes and risk of multiple adverse effects. Biologic agents such as etanercept (ETN) have revolutionized the therapeutic management of psoriasis, allowing the treatment of most difficult cases, and fragile patients.Areas covered: The authors searched PubMed using the term "psoriasis", "etanercept" and "safety". Articles considered by the auth...
Source: Expert Opinion on Drug Safety - March 19, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

An update on the safety of apremilast for the treatment of plaque psoriasis.
Authors: Shavit E, Shear NH Abstract Introduction: Apremilast is an oral phosphodiesterase inhibitor, approved for moderated to severe psoriasis in adults. Despite the advancement in dermatology, and the introduction of newer biological drugs, apremilast this is the only novel oral medication that has been introduced to treat psoriasis in the past two decades. Like additional other more traditional oral medications, its advantages and disadvantages should be discussed and compared within this group of oral systemic medications.Area covered: We conducted a review to assess the safety, efficacy and adherence of aprem...
Source: Expert Opinion on Drug Safety - March 19, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The Safety of baricitinib in patients with rheumatoid arthritis.
Authors: Honda S, Harigai M Abstract Introduction: Despite improvement in disease outcomes and prognosis, a substantial number of patients with rheumatoid arthritis (RA) still require a novel agent for effective treatment. Baricitinib is a targeted synthetic disease-modifying antirheumatic drug (tsDMARDs) that selectively inhibits Janus kinase (JAK1/JAK2), an important enzyme in the pathogenesis of RA.Areas covered: This paper aimed to evaluate the pharmacodynamics and pharmacokinetics of baricitinib, while reviewing its safety and efficacy in the treatment of RA.Expert opinion: Randomized controlled trials of bari...
Source: Expert Opinion on Drug Safety - March 17, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Spontaneous reports of hypersensitivity adverse drug reactions in Portugal: a retrospective analysis.
Conclusions: Most hypersensitivity ADRs were serious, unexpected and with strong causal relationship with suspected drugs. Allopurinol was the top-causative drug. In addition to antibiotics and anti-inflammatories, antineoplastic agents were frequently cited. The results of this study deserve further investigation to better characterize risk factors associated with hypersensitivity ADRs, particularly in those induced by allopurinol and antineoplastic agents. PMID: 32167395 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 15, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

19th Annual Meeting of the Safety Pharmacology Society: regulatory and safety perspectives for advanced therapy medicinal products (cellular and gene therapy products).
This report summarizes and discusses talks delivered at an educational course offered during the 2019 Annual Meeting of the Safety Pharmacology Society on advanced therapy medicinal products (ATMPs) and cell gene therapeutic products (CGTPs).Areas covered: ATMPs and CGTPs comprise gene and cell therapy medicinal products, tissue-engineered products, or the incorporation of one of these products into a medical device. Cited examples of ATMPs are autologous CD34+ cells encoding for the βA-T87Q-globin gene, CAR (chimeric antigen receptor)-T cell immunotherapy medicines, genome editing products, and engineered heart muscl...
Source: Expert Opinion on Drug Safety - March 13, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety and efficacy of pembrolizumab for the treatment of non-small cell lung cancer.
Authors: Mazarico Gallego JM, Herrera Juárez M, Paz-Ares L Abstract Introduction: Lung cancer is the leading cancer-related cause of death worldwide. The introduction of immune checkpoint inhibitors (ICIs) for the treatment of lung cancer has significantly improved the outcome of these patients. Pembrolizumab, a monoclonal IgG4-kappa antibody against programmed-death-1 (PD-1) protein, nowadays represents a standard of care for NSCLC patients. Although it has a favourable toxicity profile, some immune-related adverse events (irAEs) can be life-threatening, therefore its knowledge may help to optimize the care...
Source: Expert Opinion on Drug Safety - March 6, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety evaluation of dimethyl fumarate in moderate-to-severe psoriasis.
This article covers the basic concepts underlying usefulness of DMF in psoriasis and extensively reviews the studies, which included its use in monotherapy of this dermatosis, with a particular emphasis on safety aspects and adverse events (AE).Expert opinion: DMF monotherapy is a valuable systemic modality in the management of moderate to severe psoriasis as proved by a recent phase III study. AE associated with DMF therapy are frequent, usually of mild severity, with a dose independent manner. Occasionally they are burdensome and require drug discontinuation. The most common AE comprise gastrointestinal symptoms, flushin...
Source: Expert Opinion on Drug Safety - March 6, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Advanced analytics - translating registry science into regulatory actions.
Authors: Kemp K, Brun NC, Quartarolo JP PMID: 32125192 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 5, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Neurologic complications of immune checkpoint inhibitors.
Authors: Haugh AM, Probasco JC, Johnson DB Abstract Introduction: Immune checkpoint inhibitors (ICI) are associated with a wide spectrum of neurologic immune-related adverse events (irAEs) including meningo-encephalitis, myasthenia gravis and various neuropathies. Although relatively rare, they often present significant diagnostic complexity and may be under-recognized. Permanent neurologic deficits and/or fatality have been described but improvement is noted in most cases with ICI discontinuation and immunosuppressive therapy.Areas Covered: This review highlights the most frequently reported ICI-associated neurolo...
Source: Expert Opinion on Drug Safety - March 5, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A comprehensive overview and safety evaluation of fremanezumab as a preventive therapy for migraine.
Authors: Parikh SK, Burkett JG, Silberstein SD Abstract Introduction: Fremanezumab, a humanized monoclonal antibody targeting calcitonin gene-related peptide (CGRP mAb), is a migraine-specific treatment for migraine prevention.Areas covered: This review will briefly discuss other available and emerging CGRP mAbs and the neurophysiology of fremanezumab. The review will focus on phase III trials of the efficacy of fremanezumab for episodic and chronic trials, and a recent pooled safety and tolerability analysis of its use.Expert opinion: Continued efficacy and safety data collection will help guide long-term risk and...
Source: Expert Opinion on Drug Safety - March 3, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Are biosimilars approved for use in psoriasis safe enough to replace leading biologic therapies? A review.
The objective of this review is to summarize the safety data for each of the approved TNF-alpha biosimilars to determine whether or not these agents have appropriate safety profiles to replace their originator biologics.Expert opinion: Based on extrapolation of phase III investigations in patients with rheumatologic diseases, each of the approved anti-TNF agents have comparable efficacy, tolerability, and safety profiles to their originators. Studies in patients with psoriasis are more limited. Transitioning from a biologic to its biosimilar has also been shown to be similarly safe and immunogenetic compared to maintenance...
Source: Expert Opinion on Drug Safety - March 3, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Long-term safety of adalimumab for patients with moderate-to-severe hidradenitis suppurativa.
Authors: Tzanetakou V, Stergianou D, Giamarellos-Bourboulis EJ Abstract Introduction: Hidradenitis suppurativa (HS) is a chronic debilitating inflammatory skin disorder that affects regions rich in apocrine glands. Although the etiology of HS is not clear, inflammatory cytokines, like tumor necrosis factor (TNF)-α, participate in pathogenesis. Adalimumab (ADA), a human IgG1 monoclonal antibody that selectively targets TNFα, is the only EMA/FDA-approved biologic agent available for the therapy of moderate-to-severe HS.Areas covered: A comprehensive literature search was conducted to present existing stud...
Source: Expert Opinion on Drug Safety - February 28, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of current and emerging therapies for multiple myeloma.
Authors: Nadeem O, Anderson KC Abstract Introduction: Multiple myeloma therapy has evolved significantly over the past several decades due to discovery of numerous novel agents. These targeted agents are highly effective, but differ in their toxicity profiles. This literature review will highlight the safety of current and emerging myeloma therapy.Areas covered: Therapeutic agents that are reviewed for safety and efficacy data include alkylators, proteasome inhibitors, immunomodulatory agents, monoclonal antibodies, nuclear export inhibitor, and histone deacetylase inhibitor. Emerging studies of BCL2 inhibitors and...
Source: Expert Opinion on Drug Safety - February 28, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

FDA Biosimilar Action Plan: could improving pharmacovigilance of biologics improve patient and physician confidence in biosimilars?
Authors: Jordan JB, Christl L PMID: 32098520 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - February 28, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A drug safety evaluation of risankizumab for psoriasis.
Authors: Huang YW, Tsai TF Abstract Introduction: Risankizumab is a fully human monoclonal antibody that selectively targets interleukin (IL)-23A, interfering with the IL-23/17 axis that plays a crucial role in keratinocyte proliferation. In 2019, risankizumab was approved globally for the treatment of moderate-to-severe psoriasis.Areas covered: The safety profile of risankizumab for the treatment of psoriasis is assessed in this review. A literature search was performed on 18 October 2019, and additional data from pooled safety analyses were evaluated.Expert opinion:Drugs blocking the IL-23 pathway are the most re...
Source: Expert Opinion on Drug Safety - February 28, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Development of hyponatremia after terlipressin in cirrhotic patients with acute gastrointestinal bleeding: a retrospective multicenter observational study.
Authors: Xu X, Lin S, Yang Y, Chen Y, Liu B, Li B, Wu Y, Meng F, Zhu Q, Li Y, Tang S, Yuan S, Shao L, Qi X Abstract Background: Terlipressin can effectively control acute gastrointestinal bleeding (GIB) in cirrhotic patients by acting on the V1 receptors, but may lead to the development of dilutional hyponatremia by acting on the V2 receptors.Research design and methods: This retrospective multicenter study enrolled 674 cirrhotic patients with acute GIB in whom serum sodium concentrations were tested before and during the use of terlipressin. ΔSodium reduction ≥5 mmol/L, hyponatremia (sodium
Source: Expert Opinion on Drug Safety - February 28, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Quantitative data mining in signal detection: the Singapore experience.
Conclusions: The adoption of QDM triage into our manual reviews is a more efficient way forward in signal detection, avoiding missing important drug safety signals. PMID: 32092284 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - February 25, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Efficacy and safety profile of SGLT2 inhibitors in patients with type 2 diabetes and chronic kidney disease.
Authors: Scheen AJ Abstract Introduction: Sodium-glucose cotransporter type 2 inhibitors (SGLT2is) have a complex relationship with the kidney so that their use in patients with type 2 diabetes (T2DM) and diabetic kidney disease (DKD) has long been challenged.Areas covered: SGLT2is in patients with DKD are discussed: renal mechanisms of action, PK/PD characteristics, clinical use in patients with stage 3 DKD, effects on estimated glomerular filtration rate (eGFR) and albuminuria, cardiovascular and renal outcomes according to renal function, overall and renal safety, SGLT2is new place in updated guidelines.Expert o...
Source: Expert Opinion on Drug Safety - February 24, 2020 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research