Zolpidem high-dose abuse: what about the liver? Results from a series of 107 patients.
Conclusion: The present study shows a very low prevalence of DILI among high-dose ZLM abusers. The prevalence of hypertransaminasemia was in line with general population. On one hand ZLM has a substantially safe liver profile but on the other hand ZLM abuse and dependence, especially at very high doses, represents an emerging problem. PMID: 31177863 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - June 12, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Comparison of post-marketing surveillance approaches regarding infections related to tumor necrosis factor inhibitors (TNFIs) used in treatment of autoimmune diseases.
Authors: Chen C, Borrego ME, Roberts MH, Raisch DW Abstract Objectives: To examine agreement between the FDA Adverse Event Reporting System (FAERS) and observational studies in common infections for tumor necrosis factor inhibitors (TNFi's). Methods: Using MedDRA® preferred terms, all infection cases in FAERS with each TNFi were retrieved using EvidexTM. Observational studies reporting TNFi-related infections were identified from PubMed (OS-PM) and ClinicalTrials.gov (OS-CT). Infections with a reporting rate of ≥2% (based on percentage of total number of infections) from each data source were compiled. Fleis...
Source: Expert Opinion on Drug Safety - June 9, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Development of a list of high-risk perioperative medications for the elderly: a Delphi method.
Conclusion: This is the first study to establish a high-risk perioperative medication list in China, which can be used as a reference for intervention and evaluation of perioperative medications for the elderly population. PMID: 31169042 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - June 8, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Benefits versus risk profile of buparlisib for the treatment of breast cancer.
This article reviews preclinical data, clinical studies that have evaluated the efficacy and safety profiles of buparlisib as a monotherapy or in combination with targeted therapy (including endocrine and anti-HER2 therapy) or cytotoxics. The authors cover completed and ongoing studies to evaluate the benefit versus risk profile of buparlisib. Expert opinion: Targeting PI3K showed efficacy in BC. Buparlisib, a pan PI3K inhibitor, presents manageable but not negligible toxicity with an activity/toxicity ratio in favor of the use of emerging second generation, α-selective PI3K inhibitors for ongoing and future trials. ...
Source: Expert Opinion on Drug Safety - June 6, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

An update on the problem of osteoporosis in people with epilepsy taking antiepileptic drugs.
Authors: Miziak B, Chrościńska-Krawczyk M, Czuczwar SJ Abstract Introduction: Antiepileptic drugs (AEDs) have been associated with a negative impact on bone health. Comorbid disorders in patients with epilepsy may require drugs exerting a pro-osteoporotic effect, so a possibility of untoward interactions with AEDs is probable. Areas covered: This review discusses evidence related to the deteriorating influence of AEDs on bone, demonstrating generally stronger negative effects of conventional AEDs. Lamotrigine seems to be a safer AED in this regard. Further, literature data indicate that generally AEDs can lower t...
Source: Expert Opinion on Drug Safety - June 6, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

An update on the safety and efficacy of oral antidiabetic drugs: DPP-4 inhibitors and SGLT-2 inhibitors.
Authors: Lamos EM, Hedrington M, Davis SN Abstract Introduction: Oral antidiabetic medications are important in many type 2 diabetes care plans Areas covered: The article summarizes the cardiovascular and renal safety data for DPP-4 inhibitors and SGLT-2 inhibitors and specific safety data particular to each class. Expert opinion: DPP-4 and SGLT-2 inhibitors provide unique anti-hyperglycemic mechanisms. The cardiovascular safety profiles of DPP-4 inhibitors are promising, but do not show the strong CV risk reduction of empagliflozin and canagliflozin. The heart failure signal associated with DPP-4 inhibitor use is ...
Source: Expert Opinion on Drug Safety - June 3, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Cardiovascular events associated with nicorandil administration prior to primary percutaneous coronary intervention in patients with acute ST-segment elevated myocardial infarction: a systematic review and meta-analysis.
Conclusion: Nicorandil administration at the time of primary PCI is associated with reduced MACE (both short- and long-term) and no-reflow phenomenon in patients with STEMI. PMID: 31117845 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 24, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of treatment options for acute bacterial skin and skin structure infections.
Authors: Bassetti M, Peghin M, Castaldo N, Giacobbe DR Abstract INTRODUCTION: Acute bacterial skin and skin-structure infections (ABSSSI) may develop in both in-patients and out-patients, possibly with a severe clinical presentation. Since most phase 3 randomized clinical trials have shown non-inferiority in efficacy across different agents, considerations regarding their different safety profiles inevitably play a crucial role in the everyday choice about which of them should be employed for the treatment of ABSSSI. Areas covered: In this review the authors discuss the safety profile of different treatment options...
Source: Expert Opinion on Drug Safety - May 22, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety of epidural drugs: a narrative review.
Authors: van Zuylen ML, Ten Hoope W, Bos E, Hermanides J, Stevens MF, Hollmann MW Abstract INTRODUCTION: Epidural analgesia is a popular approach to postoperative and labor pain. Neurotoxicity and drug-specific systemic side effects can occur after epidural administration. As an increasing number of epidural drugs are studied and clinically applied, drug efficacy and safety evaluation are crucial. Areas covered: In this narrative review, the authors provide a thorough overview on the safety of the most widely used epidural drugs, focusing on potential neurotoxicity, side effects, and complications in the adult, non...
Source: Expert Opinion on Drug Safety - May 22, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of eribulin for the treatment of metastatic breast cancer.
Authors: Perez-Garcia JM, Cortes J Abstract INTRODUCTION: Eribulin mesylate is a highly potent anticancer agent approved for use in pretreated metastatic breast cancer (MBC). Clinical trials of eribulin in MBC have demonstrated activity against this tumor type, and a phase 3 study in patients with MBC previously treated with an anthracycline and a taxane showed a significant increase in overall survival (OS) with eribulin versus control regimens. Areas covered: This review presents overviews of the development of eribulin, its pharmacology, and its efficacy in MBC. A detailed review of its safety profile is present...
Source: Expert Opinion on Drug Safety - May 22, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety and tolerability of injectable lipid-lowering drugs: an update of clinical data.
Authors: Strilchuck L, Fogacci F, Cicero AF Abstract INTRODUCTION: Cardiovascular (CV) diseases are the leading cause of death and disability in the developed countries. Lipid-lowering therapy is a cornerstone of the CV risk modification strategy. The first line treatment for hyperlipidemia is statins, which decrease low-density lipoprotein cholesterol (LDL-C) by 30-50% and proportionally reduce the CV events. However, they are not always enough to achieve LDL-C goals in many patients, and some patients are statin intolerant. For this reason, new powerful injectable lipid-lowering drugs have been developed. Areas c...
Source: Expert Opinion on Drug Safety - May 19, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Disproportionality analysis of bullous pemphigoid adverse events with PD-1 inhibitors in the FDA Adverse Event Reporting System.
CONCLUSION: When prescribing PD-1 inhibitors, physicians should monitor closely for symptoms of bullous pemphigoid. PMID: 31088310 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 17, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Update on drug safety evaluation of naltrexone/bupropion for the treatment of obesity.
Authors: Bello NT PMID: 31092063 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - May 17, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Drug safety evaluation of aripiprazole in bipolar disorder.
Authors: Cuomo A, Beccarini Crescenzi B, Goracci A, Bolognesi S, Giordano N, Rossi R, Facchi E, Neal SM, Fagiolini A Abstract INTRODUCTION: Safety and tolerability of medications are key variables to inform treatment choice for patients with bipolar disorder (BD). This review focuses on the overall tolerability and safety profile of aripiprazole when used for its bipolar disorder indications, which include acute treatment of manic and mixed episodes and maintenance treatment of bipolar I disorder for the oral formulation, agitation associated with bipolar mania for the injectable immediate-release formulation, and ...
Source: Expert Opinion on Drug Safety - May 12, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Ivabradine for treatment of heart failure.
Authors: Bocchi EA, Salemi VMC Abstract INTRODUCTION: Heart failure with reduced ejection fraction (HFrEF) is associated with a worse outcome. Heart rate (HR) is related to outcome in HFrEF. Ivabradine selectively inhibits If (funny) channels in a concentration-dependent manner reducing HR. Areas covered: The effects of ivabradine in HF were reviewed. The SHIFT trial results indicated that ivabradine improves chronic HFrEF outcomes, whereas published data suggest that amiodarone, digoxin, or verapamil may not be safe or the safety is controversial in HFrEF patients. In the CONSTATHE-DHF study, ivabradine reduced HR...
Source: Expert Opinion on Drug Safety - May 12, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Risk of tuberculosis reactivation associated with traditional disease modifying anti-rheumatic drugs and non-anti-tumor necrosis factor biologics in patients with rheumatic disorders and suggestion for clinical practice.
Discussion on the need for LTBI diagnosis in rheumatic patients treated csDMARDs and non-anti-TNFs through a review of the literature. The literature, updated to 15 April 2019, on tuberculosis (TB) reactivation risk in patients exposed to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and non-anti-TNF biologics was reviewed. Expert opinion: An increased risk of TB reactivation in patients receiving csDMARDs (except sulphasalazine) resulted, while a review of clinical trials, and Periodic Safety Update Reports from pharmaceutical Companies evidenced a very low or absent risk for non-anti-TNF biologi...
Source: Expert Opinion on Drug Safety - May 10, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Occurrence of hepatocellular carcinoma after direct-acting antiviral therapy for hepatitis C virus infection: literature review and risk analysis.
Authors: Galati G, Muley M, Vigano M, Iavarone M, Vitale A, Dell'Unto C, Lai Q, Cabibbo G, Sacco R, Villa E, Trevisani F Abstract INTRODUCTION: Concerns were raised about a high occurrence of hepatocellular carcinoma (HCC) after successful treatment of chronic hepatitis C (CHC) by direct-acting antivirals (DAAs). Areas covered: The authors summarize the clinical studies reporting the occurrence rate and risk factors of HCC after DAAs in CHC. Expert opinion: The recent introduction of all-oral DAAs has substantially changed the scenario of CHC, achieving a sustained virological response (SVR) in>90% of cases. Ear...
Source: Expert Opinion on Drug Safety - May 10, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Muscle and statins: from toxicity to the nocebo effect.
Authors: Pedro-Botet J, Climent E, Benaiges D Abstract INTRODUCTION: Although statins have a satisfactory safety profile and are well tolerated, many statin-treated patients report muscle symptoms in clinical practice which contribute to drug discontinuation and, consequently, adverse cardiovascular outcomes. Areas covered: This narrative review will cover the definition and prevalence of statin intolerance, the clinical spectrum of statin-associated muscle symptoms (SAMS) with special focus on patients with only mild myalgias, the complexity of statin muscle intolerance diagnosis and provide an overview on the noc...
Source: Expert Opinion on Drug Safety - May 10, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A comparative safety review of histone deacetylase inhibitors for the treatment of myeloma.
Authors: Cengiz Seval G, Beksac M Abstract INTRODUCTION: Dysregulation of histone deacetylase (HDAC) activity is an epigenetic hallmark of multiple myeloma (MM), leading to aberrant gene expression and cellular signaling in myeloma cell growth, survival and resistance to therapy. Hyper-methylation at diagnosis is a frequent observation, which eventually may convert to hypo-methylation during advanced phases. Areas covered: A literature search on 'HDAC inhibitors' and 'multiple myeloma' was carried out using PubMed and Google Scholar in the preparation of this overview on clinical efficacy and safety data. Expert op...
Source: Expert Opinion on Drug Safety - May 10, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

An update on the conquests and perspectives of cardio-oncology in the field of tumor angiogenesis-targeting TKI-based therapy.
Authors: Galvano A, Guarini A, Iacono F, Castiglia M, Rizzo S, Tarantini L, Gori S, Novo G, Bazan V, Russo A Abstract INTRODUCTION: The angiogenesis mechanism is considered a crucial point in neoplastic development. A growing number of multi-targeted tyrosine kinase inhibitors (TKI) has been developed and approved for cancer treatment during the last few years. Cardiac side effects still remain an issue to manage nowadays. These drugs mechanisms and toxicities have already been discussed, hence the authors will report updates on these already available drugs. Area covered: This manuscript provides an updated review...
Source: Expert Opinion on Drug Safety - May 9, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

An updated review of glucocorticoid-related adverse events in patients with rheumatoid arthritis.
Authors: Luís M, Freitas J, Costa F, Buttgereit F, Boers M, Da Silva J, Santiago T Abstract INTRODUCTION: Glucocorticoids represent a cornerstone in the treatment of rheumatoid arthritis. Their effect as a disease-modifying treatment in rheumatoid arthritis is well established. Despite this, the risk of adverse events of glucocorticoids, especially in high doses and over a long time, is constantly highlighted. Data on the prevalence and impact of glucocorticoid-related adverse effects in rheumatoid arthritis is needed, therefore, to be regularly revisited. Areas covered: In this review, our primary aim was t...
Source: Expert Opinion on Drug Safety - May 7, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Role of healthcare databases and registries for surveillance of orphan drugs in the real-world setting: the Italian case study.
Authors: Trifirò G, Crisafulli S, Sultana J, Ingrasciotta Y, Addis A, Cananzi P, Lorenzo C, Conter V, D'Angelo G, Ferrajolo C, Mantovani L, Pastorello M, Scondotto S Abstract INTRODUCTION: Orphan drugs are medicines intended to treat, prevent, or diagnose a rare and serious condition. The collection of pre-marketing safety and efficacy data for orphan drugs is very challenging for several reasons related to the rarity of the diseases. This highlights the need for robust post-marketing evidence generation. Real-world data sources, such as claims databases, electronic healthcare records and disease and drug re...
Source: Expert Opinion on Drug Safety - May 7, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

A safety review of recent advancements in the treatment of psoriasis: analysis of clinical trial safety data.
Authors: Kolli SS, Kepley AL, Cline A, Feldman SR Abstract INTRODUCTION: Psoriasis is a chronic, inflammatory condition whose management can include oral medications and injectable biologics. Safety data of these various treatment options are important to consider when choosing the right treatment for the patient. Areas covered: This review evaluates the safety of newer treatments approved for psoriasis, including interleukin-(IL)-17 inhibitors, IL-23/p19 inhibitors, ustekinumab, certolizumab pegol and apremilast, using phases III and IV clinical trial data. Expert opinion: Even as treatment of psoriasis becomes mo...
Source: Expert Opinion on Drug Safety - May 5, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Analgesic treatments in people with dementia - how safe are they? A systematic review.
This article presents a systematic review of the current evidence for safety and tolerability of analgesic drugs from randomized controlled trials in people with dementia. Relevant trials were identified by a literature search in the EMBASE, MEDLINE and Cochrane databases from inception to November 2018. The search included the main terms 'dementia' and 'analgesic' or their subterms, and was filtered to limit results to clinical trials. Expert opinion: Although pain treatment is increasingly recognized as an important clinical issue in people with advanced dementia, there is currently a lack of evidence to support safety e...
Source: Expert Opinion on Drug Safety - May 2, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

15 years of patient reporting -what have we learnt and where are we heading to?
This article is based on Lareb studies on patient reporting from 2004 onwards and covers the evolution of the Dutch patient reporting system, the value of patient participation in pharmacovigilance, impact of patient reporting on the spontaneous reporting system and future steps to strengthen patient reporting. Expert opinion: After 15 years of experience with patient reporting we conclude that patients can add value to pharmacovigilance. We recognize that there is a big leap between allowing patients to report and actual patient involvement in pharmacovigilance. It is our belief that increased patient involvement in pharm...
Source: Expert Opinion on Drug Safety - April 30, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Are risk minimization measures for approved drugs in Europe effective? A systematic review.
CONCLUSION: Surveys are necessary to evaluate many RMMs. Challenges remain in the design, conduct and reporting of these studies which may benefit from use of standard definitions and further guidance on reporting. PMID: 31032651 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 30, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The role of take-home naloxone in the epidemic of opioid overdose involving illicitly manufactured fentanyl and its analogs.
Authors: Kim HK, Connors NJ, Mazer-Amirshahi ME Abstract INTRODUCTION: There has been an exponential increase in overdose fatalities as illicitly manufactured fentanyl and its analogs (IMF) are becoming more prevalent in the illicit drug supply. In response, overdose education and naloxone distribution (OEND) programs have been implemented throughout the United States as a harm reduction strategy. However, there are increasing reports that higher naloxone doses or repeat administration might be required for overdose victims involving IMF. Areas covered: In this article, we provide a comprehensive review of the epid...
Source: Expert Opinion on Drug Safety - April 30, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety of drugs used for the treatment of Crohn's disease.
Authors: Pudipeddi A, Kariyawasam V, Haifer C, Baraty B, Paramsothy S, Leong RW Abstract INTRODUCTION: Medications in treating Crohn's disease (CD) have evolved over the last two decades, particularly with the use of biologic agents. There are, however, concerns about the safety and adverse events associated with these medications. The authors review the safety profile of immunosuppressive medications used in Crohn's disease in adult patients. Areas covered: The authors performed a literature search until October 2018 to examine safety data on thiopurines, methotrexate, anti-TNFα agents, vedolizumab and ustek...
Source: Expert Opinion on Drug Safety - April 27, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

An update on heart disease risk associated with testosterone boosting medications.
Authors: Corona G, Rastrelli G, Guaraldi F, Tortorici G, Reismann Y, Sforza A, Maggi M Abstract INTRODUCTION: The cardiovascular (CV) safety of testosterone replacement therapy (TRT) remains a crucial issue in the management of subjects with late onset hypogonadism. The authors systematically reviewed and discussed the available evidence focusing our analysis on heart related issues. Areas covered: All the available data from prospective observational studies evaluating the role endogenous T levels on the risk of acute myocardial infarction (AMI) were collected and analyzed. In addition, the impact of TRT on heart ...
Source: Expert Opinion on Drug Safety - April 20, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Pediatric drug safety signal detection of non-chemotherapy drug-induced neutropenia and agranulocytosis using electronic healthcare records.
CONCLUSION: A method to detect signals for DIN and DIA has been described. Several pediatric drugs were found to be associated with DIN or DIA. PMID: 31002530 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 20, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Are biological drugs effective and safe in older severe asthmatics?
Authors: Benfante A, Principe S, Battaglia S, Scichilone N Abstract INTRODUCTION: The treatment of asthma in the most advanced ages follows the recommendations of international guidelines for the management of asthma in younger ages, although older age has always represented an exclusion criterion for eligibility to pharmacological trials. This poses a clinical challenge when deciding whether elderly severe asthmatics are candidates for biological drugs. Areas covered: The current article has a narrative structure to review current literature on efficacy and safety of novel pharmacological drugs against immunoglobu...
Source: Expert Opinion on Drug Safety - April 17, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Update on BRAF and MEK inhibition for treatment of melanoma in metastatic, unresectable, and adjuvant settings.
Authors: Broman KK, Dossett LA, Sun J, Eroglu Z, Zager JS Abstract INTRODUCTION: Selective inhibition of the MAPK pathway with BRAF and MEK inhibitors has emerged as a key component of the treatment of BRAF-mutant unresectable/locally advanced metastatic melanoma. Areas covered: Current data are presented on the efficacy and safety of BRAFi + MEKi combination therapy (dabrafenib/trametinib, vemurafenib/cobimetinib, and encorafenib/binimetinib) from phase I, II, and III trials in the unresectable/locally advanced metastatic setting, as well as neoadjuvant and adjuvant applications. The theoretical basis, pre-clinica...
Source: Expert Opinion on Drug Safety - April 13, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The safety of treating newly diagnosed epilepsy.
Authors: Sharma S, Kwan P Abstract INTRODUCTION: Epilepsy is a serious chronic neurological disorder manifested by an enduring symptomatic predisposition to seizures. Newly diagnosed individuals face increased morbidity, mortality and socio-economic costs. Anti-epileptic drug therapy is the treatment usually prescribed, which has efficacy in seizure control and mitigating long-term mortality. Areas covered: Safety of anti-epileptic drug therapy in adults with focus in newly diagnosed patients. Areas covered include the most commonly experienced adverse drug effects, as well as those with the highest impacts on drug...
Source: Expert Opinion on Drug Safety - April 6, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Review of the long-term safety of lomitapide: a microsomal triglycerides transfer protein inhibitor for treating homozygous familial hypercholesterolemia.
Authors: Khoury E, Brisson D, Roy N, Tremblay G, Gaudet D Abstract INTRODUCTION: Homozygous familial hypercholesterolemia (HoFH) is a rare and life-threatening lipid disorder characterized by extremely elevated low-density lipoprotein-cholesterol (LDL-C) concentrations and premature atherosclerotic cardiovascular disease (CVD). Conventional lipid-lowering agents remain insufficient in managing this disease, which emphasize the unmet medical need for potential therapies capable of lowering LDL-C and decreasing CVD risk in this patient population. Areas covered: Novel LDL receptor (LDLR) independent drugs have been r...
Source: Expert Opinion on Drug Safety - April 6, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Potentially inappropriate concomitant medicine use with the selective COX-2 inhibitor celecoxib: Analysis and comparison of spontaneous adverse event reports from Australia, Canada and the USA.
CONCLUSIONS: The large number of reports that involved a concomitant medicine that was in contravention with prescribing guidelines indicates an increased need for efforts to support the safe prescribing of celecoxib. PMID: 30929580 [PubMed - in process] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 3, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

An update on the safety of SGLT2 inhibitors.
Authors: Scheen AJ Abstract INTRODUCTION: Sodium-glucose cotransporter type 2 inhibitors (SGLT2is) are recommended after metformin for a large spectrum of patients with type 2 diabetes, because of a favourable benefit/risk profile despite a variety of adverse events. Areas covered: This narrative review discusses the safety profile of SGLT2is: initial concerns (cardiovascular safety, acute renal failure, hypoglycemia, urinary and genital infections, volume depletion, bladder cancer), further concerns (euglycemic ketoacidosis, bone fractures) and more recent concerns (lower limb amputation, Fournier's gangrene). Exp...
Source: Expert Opinion on Drug Safety - April 3, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Immunogenicity of infliximab and adalimumab.
Authors: Murdaca G, Negrini S, Greco M, Schiavi C, Giusti F, Borro M, Puppo F PMID: 30938213 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - April 3, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Efficacy and safety of Xa inhibitors for the treatment of cancer-associated venous thromboembolism.
Authors: Kimpton M, Carrier M Abstract INTRODUCTION: Cancer patients with cancer-associated thrombosis (CAT) are at an elevated risk of recurrent venous thromboembolism (VTE) and of major bleeding while receiving treatment with anticoagulation. Recently, Xa inhibitors have been assessed in cancer patients for the treatment of CAT, providing clinicians and patients with more treatment options. Areas covered: In this narrative review, the authors evaluate the evidence regarding the efficacy and safety of edoxaban, rivaroxaban, and apixaban in the treatment of CAT. Expert opinion: Xa inhibitors are an effective, safe,...
Source: Expert Opinion on Drug Safety - March 31, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety and tolerability of available urate-lowering drugs: a critical review.
Authors: Strilchuk L, Fogacci F, Cicero AF Abstract INTRODUCTION: Urate-lowering therapy (ULT) is the cornerstone of gout management, which is a widespread chronic illness characterized by hyperuricemia, arthropathy, tophus development, and urolithiasis. Since asymptomatic increased serum urate levels are associated with a higher risk of cardiovascular, renal and metabolic disorders, a larger use of ULTs in the general population is expected in the near future. Areas covered: This review will focus on the safety and tolerability profile of the available urate-lowering drugs: xanthine oxidase inhibitors (XOIs), uric...
Source: Expert Opinion on Drug Safety - March 28, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Surveillance of adverse events following immunization related to human papillomavirus vaccines: 12 years of vaccinovigilance in Southern Italy.
CONCLUSION: The overall results of the study demonstrated that, except for few cases, AEFIs related to HPV vaccines reflect those already reported in the summary of product characteristics. The authors did not identify any new safety issues or serious, rare or unexpected AEFIs that were medically confirmed to be related to HPV vaccines. PMID: 30907147 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 27, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety and immunogenicity of pneumococcal conjugate vaccines in preterm infants.
Authors: López-Sanguos C, Rivero Calle I, Rodriguez Tenreiro C, Raguindin PF, Martinón-Torres F Abstract INTRODUCTION: The introduction of pneumococcal conjugate vaccines (PCVs) in the routine immunization program has resulted in a significant decline in invasive pneumococcal diseases (IPD) around the world. Preterm infants are a special group at a high risk of invasive infection by encapsulated bacteria. However, their slow growth accrual and prolonged hospital stays frequently lead to delays in immunization, which contributes to their risk of severe infections. Areas covered: Authors reviewed the pu...
Source: Expert Opinion on Drug Safety - March 27, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

An update on the safety of tacrolimus in kidney transplant recipients, with a focus on tacrolimus minimization.
Authors: Jouve T, Noble J, Rostaing L, Malvezzi P Abstract INTRODUCTION: Tacrolimus-based immunosuppression remains the immunosuppressive drug of choice in kidney transplantation. Areas covered: Its safety profile is closely linked to its pharmacokinetic properties. A narrow therapeutic range allows to limit under- and over-immunosuppression consequences. Minimization of tacrolimus exposure, using appropriate companion drugs, leads to the best renal outcomes in the long-term. Also, reducing tacrolimus exposure variability helps in reducing tacrolimus toxicity. The novel concept of tacrolimus concentration-to-dose r...
Source: Expert Opinion on Drug Safety - March 27, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Response to the letter to the editor: Comment on "The need for contraception in patients taking prescription drugs: a review of FDA warning labels, duration of effects, and mechanisms of action" by Zhang et al.
Response to the letter to the editor: Comment on "The need for contraception in patients taking prescription drugs: a review of FDA warning labels, duration of effects, and mechanisms of action" by Zhang et al. Expert Opin Drug Saf. 2019 Mar 19;:1 Authors: Li H, Rayburn E PMID: 30888209 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 21, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Collaboration between patient and pharmacovigilance organizations to gain insight into adults' experiences with drug use and ADRs for the treatment of ADHD.
Conclusions Collaboration with patient organizations provide useful insight into patients' experiences with drug use and ADRs taking into account establishing clear 'rules of engagement'. An active approach to collaborate with patient organizations is a way forward to gain more information about drug use and ADRs in a selective cohort. PMID: 30845849 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 10, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Letter to Editor: Comment on "The need for contraception in patients taking prescription drugs: a review of FDA warning labels, duration of effects, and mechanisms of action" by Zhang et al.
Letter to Editor: Comment on "The need for contraception in patients taking prescription drugs: a review of FDA warning labels, duration of effects, and mechanisms of action" by Zhang et al. Expert Opin Drug Saf. 2019 Mar 01;: Authors: Cem Kaplan Y, Juch H PMID: 30822388 [PubMed - as supplied by publisher] (Source: Expert Opinion on Drug Safety)
Source: Expert Opinion on Drug Safety - March 4, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Understanding the cardiovascular risk with non-insulin antidiabetic drugs.
Authors: Athyros VG, Imprialos K, Stavropoulos K, Sahinidis A, Doumas M Abstract INTRODUCTION: Diabetes mellitus is a major public health problem with significant macro- and micro-vascular complications. Achievement of glucose control is associated with substantial reduction of micro-vascular events, while the effects of antidiabetic drugs in macro-vascular complications are less clear. This review summarizes and critically discusses the cardiovascular effects of non-insulin antidiabetic agents. Areas covered: A selective literature search of Pubmed was performed regarding the efficacy and safety of non-insulin ant...
Source: Expert Opinion on Drug Safety - February 28, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

The role of antimicrobial treatment during pregnancy on the neonatal gut microbiome and the development of atopy, asthma, allergy and obesity in childhood.
Authors: Milliken S, Allen RM, Lamont RF Abstract INTRODUCTION: The use of antibiotics prenatally, during pregnancy, or neonatally may have adverse effects on the neonatal gut microbiome, and adversely affect the development of the infant immune system, leading to the development of childhood atopy, asthma, allergy and obesity. Areas covered: We reviewed new evidence about vaginal eubiosis and dysbiosis from molecular-based, cultivation-independent techniques, and how this affects the neonatal gut microbiome and early development of the immune system in infants. We have considered the association between maternal u...
Source: Expert Opinion on Drug Safety - February 13, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Potential strategies to combat the opioid crisis.
Authors: Mercadante S Abstract INTRODUCTION: In the last few decades, the consumption of opioid analgesics in many countries, particularly the US, has dramatically increased. This rise has been paralleled by a proportional number of opioid-related deaths. Areas covered: The development of opioid guidelines was a response to this health crisis with the intention of reducing the risk of harm related to opioid prescribing. These guidelines have received varying responses ranging from support to criticism. Pain physicians may often provide multidimensional management as the paradigm for responsible opioid treatment. In...
Source: Expert Opinion on Drug Safety - February 8, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Making a case for the right "-ase" in acute ischemic stroke: alteplase, tenecteplase, and reteplase.
Making a case for the right "-ase" in acute ischemic stroke: alteplase, tenecteplase, and reteplase. Expert Opin Drug Saf. 2019 Feb 04;: Authors: Wyatt Chester K, Corrigan M, Schoeffler JM, Shah M, Toy F, Purdon B, Dillon GM Abstract INTRODUCTION: Alteplase, reteplase, and tenecteplase are tissue plasminogen activators (TPA) approved for the management of acute myocardial infarction. Only alteplase is also approved for the treatment of acute ischemic stroke (AIS). The US Food and Drug Administration has received reports of accidental administration of tenecteplase or reteplase instead of alte...
Source: Expert Opinion on Drug Safety - February 5, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research

Safety of direct oral anticoagulants in real world clinical practice: translating the trials to everyday clinical management.
Authors: Fawzy AM, Yang WY, Lip GY Abstract INTRODUCTION: Direct oral anticoagulants (DOACs) may be regarded as some of the most successful innovations in recent times. These drugs which were specifically developed to overcome the challenges posed by warfarin did just that and in the process, have changed the outlook towards stroke prevention with anticoagulation. The decade of experience with these drugs that has resulted in the availability of large scale data on their safety profile has aided this. Areas covered: This review examines existing real-world studies and their interpretation to better appreciate how t...
Source: Expert Opinion on Drug Safety - February 5, 2019 Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research