Authors ’ Reply to Michael Auerbach’s Comment on: “Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using the US Food and Drug Administration Adverse Event Reporting System”
(Source: Drug Safety)
Source: Drug Safety - April 9, 2021 Category: Drugs & Pharmacology Source Type: research

Comment on: Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using the US Food and Drug Administration Adverse Event Reporting System
(Source: Drug Safety)
Source: Drug Safety - April 9, 2021 Category: Drugs & Pharmacology Source Type: research

Population-Based Observational Study of Adverse Drug Event-Related Mortality in the Super-Aged Society of Japan
ConclusionsThe number of and trend in ADE-related deaths increased in Japan from 1999 to 2016, particularly in the older population. (Source: Drug Safety)
Source: Drug Safety - April 7, 2021 Category: Drugs & Pharmacology Source Type: research

An Update of the North American Chapter of the International Society of Pharmacovigilance (NASoP)
(Source: Drug Safety)
Source: Drug Safety - April 2, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: Enhancing Pharmacovigilance in Sub-Saharan Africa Through Training and Mentoring: A GSK Pilot Initiative in Malawi
A correction to this paper has been published: https://doi.org/10.1007/s40264-021-01064-0 (Source: Drug Safety)
Source: Drug Safety - March 31, 2021 Category: Drugs & Pharmacology Source Type: research

ISoP Fellowships: Recognising and Promoting Leaders in Pharmacovigilance
(Source: Drug Safety)
Source: Drug Safety - March 18, 2021 Category: Drugs & Pharmacology Source Type: research

Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials
AbstractCausality assessment for suspected drug-induced liver injury (DILI) during drug development and following approval is challenging. The IQ DILI Causality Working Group (CWG), in collaboration with academic and regulatory subject matter experts (SMEs), developed this manuscript with the following objectives: (1) understand and describe current practices; (2) evaluate the utility of new tools/methods/practice guidelines; (3) propose a minimal data set needed to assess causality; (4) define best practices; and (5) promote a more structured and universal approach to DILI causality assessment for clinical development. To...
Source: Drug Safety - March 16, 2021 Category: Drugs & Pharmacology Source Type: research

Real-World Fetal Exposure to Acne Treatments in the United States: A Retrospective Analysis from 2006 to 2015
AbstractIntroductionSeveral studies have evaluated the effects of changes in isotretinoin risk mitigation programs, but little is known about actual fetal exposure rates in the context of other acne treatments.ObjectiveOur objective was to quantify fetal exposure rates during the use of common acne treatments.MethodsEmploying the insurance claims data of> 100,000 acne treatment users between 2006 and 2015, we created three user cohorts: (1) isotretinoin (strong teratogen/mandatory risk mitigation program), (2) doxycycline/minocycline (mild teratogen, label warning), and (3) topical clindamycin/erythromycin (no fetal ris...
Source: Drug Safety - March 8, 2021 Category: Drugs & Pharmacology Source Type: research

Safety Consequences of Off-Label Drugs Used for COVID-19
(Source: Drug Safety)
Source: Drug Safety - March 5, 2021 Category: Drugs & Pharmacology Source Type: research

Provision and Need for Medicine Information in Asia and Africa: A Scoping Review of the Literature
AbstractPublished reviews of written medicine information (WMI) have mainly drawn on studies published in high-income countries, including very few Asian or African studies. We therefore set out to scope the research literature to determine the extent and type of studies concerning WMI for patients/consumers across these two continents. We sought empirical studies published between January 2004 and December 2019, conducted in any Asian or African country, as defined by the United Nations, in English or with an English abstract. The majority of the 923 papers identified were from high-income countries. We retained 26 papers...
Source: Drug Safety - March 5, 2021 Category: Drugs & Pharmacology Source Type: research

Safety of S1P Modulators in Patients with Immune-Mediated Diseases: A Systematic Review and Meta-Analysis
ConclusionsWe found an increased risk of herpes zoster infection, and transient cardiovascular events among patients treated with sphingosine-1-phosphate modulators.Clinical Trial RegistrationPROSPERO CRD42020172575. (Source: Drug Safety)
Source: Drug Safety - March 5, 2021 Category: Drugs & Pharmacology Source Type: research

Comparative Risk Assessment of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants: A Network Study Across Four Observational Databases in the USA
AbstractBackgroundAntithrombotic therapies are associated with an increased bleeding risk. Abnormal uterine bleeding data have been reported in clinical trials of patients with venous thromboembolism (VTE), but data are limited for patients with atrial fibrillation (AF).ObjectiveUsing real-world data from four US healthcare databases (October 2010 to December 2018), we compared the occurrence of severe uterine bleeding among women newly exposed to rivaroxaban, apixaban, dabigatran, and warfarin stratified by indication.MethodsTo reduce potential confounding, patients in comparative cohorts were matched on propensity scores...
Source: Drug Safety - March 2, 2021 Category: Drugs & Pharmacology Source Type: research

Liver Injury Associated with Metamizole Exposure: Features of an Underestimated Adverse Event
ConclusionsOur analysis of a well-characterised DILI cohort further supports the potential of metamizole causing DILI and provides important features for the establishment of a signature pattern of liver injury observed in patients treated with metamizole.Clinical Trial RegistrationClinicalTrials.gov: NCT 02353455. (Source: Drug Safety)
Source: Drug Safety - February 27, 2021 Category: Drugs & Pharmacology Source Type: research

Authors ’ Reply to Robert P. Giugliano and Colleagues’ Comment on: “Direct Oral Anticoagulants and Interstitial Lung Disease: Emerging Clues from Pharmacovigilance”
(Source: Drug Safety)
Source: Drug Safety - February 24, 2021 Category: Drugs & Pharmacology Source Type: research

Comment on: “Direct Oral Anticoagulants and Interstitial Lung Disease: Emerging Clues from Pharmacovigilance”
(Source: Drug Safety)
Source: Drug Safety - February 24, 2021 Category: Drugs & Pharmacology Source Type: research

Clinical Utility of Pharmacogenomic Data Collected by a Health-System Biobank to Predict and Prevent Adverse Drug Events
ConclusionPatients with actionable PGx results from a health-system biobank who received relevant medications experienced predictable ADEs. These ADEs may have been prevented if the patients ’ PGx results were available in the electronic health record with clinical decision support prior to prescribing. (Source: Drug Safety)
Source: Drug Safety - February 23, 2021 Category: Drugs & Pharmacology Source Type: research

Comparison of Medication Alerts from Two Commercial Applications in the USA
AbstractIntroductionMedication organizations across the USA have adopted electronic health records, and one of the most anticipated benefits of these was improved medication safety, but alert fatigue has been a major issue.ObjectiveWe compared the appropriateness of medication-related clinical decision support alerts triggered by two commercial applications: EPIC and Seegnal ’s platform.MethodsThis was a retrospective comparison of two commercial applications. We provided Seegnal with deidentified inpatient, outpatient, and inpatient genetic electronic medical record (EMR)-extracted datasets for 657, 2731, and 413 pa...
Source: Drug Safety - February 22, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: 19th ISoP Annual Meeting “New Opportunities for New Generations” Bogotá, Colombia, 26–29 October, 2019
The title and authorship of abstract # 51, which previously read. (Source: Drug Safety)
Source: Drug Safety - February 20, 2021 Category: Drugs & Pharmacology Source Type: research

Identification and Validation of Major Cardiovascular Events in the United Kingdom Data Sources Included in a Multi-database Post-authorization Safety Study of Prucalopride
ConclusionsGiven the limitations of relying solely on computer algorithms to identify cardiovascular outcomes, validation with clinical review is essential to guide interpretation. (Source: Drug Safety)
Source: Drug Safety - February 19, 2021 Category: Drugs & Pharmacology Source Type: research

Assessing the Impact on Health of Pharmacovigilance Activities: Example of Four Safety Signals
ConclusionThis article highlights the methodological challenges and the data required to assess the impact of product-specific safety signals. A structured assessment support tool can be used as a guide for the necessary data elements and steps needed for the measurement or estimation of impact of pharmacovigilance activities on public health, provided that the appropriate data are available. (Source: Drug Safety)
Source: Drug Safety - February 19, 2021 Category: Drugs & Pharmacology Source Type: research

Communicating About Risks and Safe Use of Medicines
(Source: Drug Safety)
Source: Drug Safety - February 19, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: Assessing the Safety of COVID-19 Vaccines: A Primer
The conflicts of interest/competing interests section, which previously read. (Source: Drug Safety)
Source: Drug Safety - February 16, 2021 Category: Drugs & Pharmacology Source Type: research

Public Perspectives of Using Social Media Data to Improve Adverse Drug Reaction Reporting: A Mixed-Methods Study
ConclusionsSocial media users value public-facing pharmacovigilance schemes, even if they do not understand the current framework of pharmacovigilance within the UK. Ongoing engagement with users is essential to understand views, share knowledge and respect users ’ privacy expectations to optimise future ADR reporting from online health communities. (Source: Drug Safety)
Source: Drug Safety - February 13, 2021 Category: Drugs & Pharmacology Source Type: research

Anticholinergic Activity of Psychotropic Drugs and Cognitive Impairment Among Participants Aged 45 and Over: The CONSTANCES Study
ConclusionOur results suggest there is no clinically relevant association between the anticholinergic activity of antidepressant and anxiolytic drugs and cognitive impairment in middle-aged adults. An association could exist between AC+ antipsychotics and executive function. (Source: Drug Safety)
Source: Drug Safety - February 11, 2021 Category: Drugs & Pharmacology Source Type: research

Risk Management for the 21st Century: Current Status and Future Needs
AbstractGlobal adoption of risk management principles outlined in the International Conference on Harmonisation (ICH) E2E guideline and the Council for International Organizations of Medical Sciences (CIOMS) Working Group VI guidance introduced greater proactivity and consistency into the practice of pharmacovigilance and benefit –risk management throughout the lifecycle of a drug. However, following the release of these guidelines there have been important advances in the science and practice of risk minimisation itself, especially in terms of how risk minimisation measures (RMMs) are designed, implemented, dissemin...
Source: Drug Safety - February 9, 2021 Category: Drugs & Pharmacology Source Type: research

Safety of As-Needed Budesonide-Formoterol in Mild Asthma: Data from the Two Phase III SYGMA Studies
ConclusionsBudesonide-formoterol anti-inflammatory reliever therapy is generally well-tolerated in patients with mild asthma and has a safety profile similar to that of daily budesonide. No new safety signals were identified.ClinicalTrial.gov IdentifiersNCT02149199 (SYGMA 1) and NCT02224157 (SYGMA 2). (Source: Drug Safety)
Source: Drug Safety - February 6, 2021 Category: Drugs & Pharmacology Source Type: research

Adverse Drug Reactions from Real-World Data in Inflammatory Bowel Disease Patients in the IBDREAM Registry
ConclusionsBased on real-world data, ADR reporting demonstrated new ADRs and higher incidences of ADRs to IBD therapies. This information will contribute to drug safety by updating the SmPCs, allowing better risk assessment and communication towards patients. (Source: Drug Safety)
Source: Drug Safety - February 4, 2021 Category: Drugs & Pharmacology Source Type: research

Upadacitinib in Rheumatoid Arthritis: A Benefit –Risk Assessment Across a Phase III Program
AbstractTreating to a target of clinical remission or low disease activity is an important principle for managing rheumatoid arthritis (RA). Despite the availability of biologic disease-modifying antirheumatic drugs (bDMARDs), a substantial proportion of patients with RA do not achieve these treatment targets. Upadacitinib is a once-daily, oral Janus kinase (JAK) inhibitor with increased selectivity for JAK1 over JAK2, JAK3, and tyrosine kinase 2. The SELECT phase III upadacitinib clinical program comprised five pivotal trials of approximately 4400 patients with RA, including inadequate responders (IR) to conventional synt...
Source: Drug Safety - February 2, 2021 Category: Drugs & Pharmacology Source Type: research

Validating Intelligent Automation Systems in Pharmacovigilance: Insights from Good Manufacturing Practices
AbstractPharmacovigilance is the science of monitoring the effects of medicinal products to identify and evaluate potential adverse reactions and provide necessary and timely risk mitigation measures. Intelligent automation technologies have a strong potential to automate routine work and to balance resource use across safety risk management and other pharmacovigilance activities. While emerging technologies such as artificial intelligence (AI) show great promise for improving pharmacovigilance with their capability to learn based on data inputs, existing validation guidelines should be augmented to verify intelligent auto...
Source: Drug Safety - February 1, 2021 Category: Drugs & Pharmacology Source Type: research

Incidence Rates of Autoimmune Diseases in European Healthcare Databases: A Contribution of the ADVANCE Project
ConclusionA range of autoimmune events could be identified in the ADVANCE system. Estimation of rates indicated consistency across selected European healthcare databases, as well as consistency with US published data. (Source: Drug Safety)
Source: Drug Safety - January 19, 2021 Category: Drugs & Pharmacology Source Type: research

Evaluation of the Risk of Inflammatory Bowel Disease after the HPV Vaccination in Primary Care in Spain: A Time-Varying Cohort Analysis of Around 390,000 Girls
ConclusionsThis study did not show an increased risk of IBD following 2 years of HPVv exposure. However, an increased risk of IBD diagnosis was observed following the first vaccination dose (1 –34 days), which is likely attributable to the clinical recommendation to vaccinate upon onset of IBD symptoms. (Source: Drug Safety)
Source: Drug Safety - January 19, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: A Comparative View of Reported Adverse Effects of Statins in Social Media, Regulatory Data, Drug Information Databases and Systematic Reviews
The article A Comparative View of Reported Adverse Effects of Statins in Social Media. (Source: Drug Safety)
Source: Drug Safety - January 15, 2021 Category: Drugs & Pharmacology Source Type: research

Correction to: DNA Barcoding and Pharmacovigilance of Herbal Medicines
The Conflicts of interest section, which previously read. (Source: Drug Safety)
Source: Drug Safety - January 2, 2021 Category: Drugs & Pharmacology Source Type: research

French Pharmacovigilance Public System and COVID-19 Pandemic
AbstractThe current COVID-19 pandemic is an exceptional health situation including for drug use. As there was no known effective drug for COVID-19 at the beginning of the pandemic, different candidates were proposed. In this short article, we present the French public pharmacovigilance activities during this health crisis. Although COVID-19 is a confounding factor per se, owing to its potential for multi-organ damage including the heart and kidney, the quality of the transmitted data in adverse drug reaction reports, the timeliness of feedback from clinicians, and the real-time pharmacological and medical analysis by the F...
Source: Drug Safety - December 28, 2020 Category: Drugs & Pharmacology Source Type: research

The DIANA Study: Continued Access to Darunavir/Ritonavir (DRV/r) and Long-Term Safety Follow-Up in HIV-1-Infected Pediatric Patients Aged 3 to & lt;  18 Years
This study provided continued access to DRV/r and assessed long-term safety in patients aged 3 to
Source: Drug Safety - December 24, 2020 Category: Drugs & Pharmacology Source Type: research

Dissemination of Direct Healthcare Professional Communications on Medication Errors for Medicinal Products in the EU: An Explorative Study on Relevant Factors
ConclusionsThe absolute number of ME DHPCs for CAPs is low and does not give rise to immediate concern. We identified potential risk factors for ME DHPCs that should be taken into account during approval procedures or line extensions. (Source: Drug Safety)
Source: Drug Safety - December 23, 2020 Category: Drugs & Pharmacology Source Type: research

A Systematic Review and Meta-Analysis Considering the Risk for Congenital Heart Defects of Antidepressant Classes and Individual Antidepressants
ConclusionsThe selective serotonin reuptake inhibitor and serotonin norepinephrine reuptake inhibitor classes of antidepressants pose a greater risk for causing congenital heart defects than the tricyclic antidepressants. However, this risk for individual antidepressants within each class varies, and information regarding some antidepressants is still lacking. (Source: Drug Safety)
Source: Drug Safety - December 22, 2020 Category: Drugs & Pharmacology Source Type: research

Global Safety Database Summary of COVID-19-Related Drug Utilization-Safety Surveillance: A Sponsor ’s Perspective
ConclusionsThis pharmacovigilance surveillance study provides a unique characterization of cases in which a broad range of pharmaceutical products was reported in relation to COVID-19. (Source: Drug Safety)
Source: Drug Safety - December 22, 2020 Category: Drugs & Pharmacology Source Type: research

PCSK9 Inhibitors and Neurocognitive Adverse Drug Reactions: Analysis of Individual Case Safety Reports from the Eudravigilance Database
ConclusionOur results demonstrated that 22.7% of all ICSRs reporting alirocumab or evolocumab as suspect drugs described the occurrence of neuropsychiatric ADRs. The ROR showed that evolocumab and alirocumab had a higher reporting probability of neurological ADRs compared with statins. Further data from real-life contexts are needed. (Source: Drug Safety)
Source: Drug Safety - December 22, 2020 Category: Drugs & Pharmacology Source Type: research

Developing Crowdsourced Training Data Sets for Pharmacovigilance Intelligent Automation
ConclusionsCrowdsourcing is an accurate and efficient method that can be used to develop training data sets in support of pharmacovigilance automation. More research is needed to better understand the breadth and depth of possible uses as well as strengths, limitations, and generalizability of results. (Source: Drug Safety)
Source: Drug Safety - December 22, 2020 Category: Drugs & Pharmacology Source Type: research

Safety of N -Acetylcysteine at High Doses in Chronic Respiratory Diseases: A Review
AbstractN-Acetylcysteine (NAC) is widely used in respiratory medicine, with a maximum licensed dose in chronic use of 600 mg/day; however, some clinical trials have studied the efficacy of NAC at higher doses. The aim of this review was to evaluate the adverse effects profile of NAC at higher than the standard dose in chronic respiratory diseases to establish a risk –benefit ratio in increasing the daily dose; therefore, studies using NAC at a dose of at least 600 mg/day were selected. Forty-one articles where NAC has been used at 600 mg and above, up to 3000 mg/day, and with a specific report on safety, were conside...
Source: Drug Safety - December 16, 2020 Category: Drugs & Pharmacology Source Type: research

Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations
AbstractPharmaceutical legislation provides a legal framework to ensure the safe and effective use of medicines. This framework requires national regulatory authorities (NRAs) to establish and maintain a pharmacovigilance system (PV system) stating and enforcing the regulatory commitments that key stakeholders, including marketing authorisation holders (MAHs), are required to fulfil. In recent years, national legislative bodies and NRAs across the world have issued a significant amount of legislation and guidance enforcing the obligation to perform pharmacovigilance activities. In countries where the NRA is a member of the...
Source: Drug Safety - December 8, 2020 Category: Drugs & Pharmacology Source Type: research

Evaluation of Opioid Overdose Reports in Patients Treated with Extended-Release Naltrexone: Postmarketing Data from 2006 to 2018
ConclusionsOver the 12-year period, the reporting rates of opioid overdose were similar during treatment with or after discontinuation of XR-NTX and
Source: Drug Safety - November 30, 2020 Category: Drugs & Pharmacology Source Type: research

Risk of Cancer in Association with Ranitidine and Nizatidine vs Other H2 Blockers: Analysis of the Japan Medical Data Center Claims Database 2005 –2018
ConclusionsWe found no evidence that ranitidine/nizatidine is associated with an increased risk of cancer, although further studies with more accurate measurement of exposure, inclusion of older people, and longer follow-up may be needed. (Source: Drug Safety)
Source: Drug Safety - November 27, 2020 Category: Drugs & Pharmacology Source Type: research

Sex Differences in Lopinavir Concentrations and Occurrence of Marked QTc Prolongation Episodes in Patients with COVID-19
(Source: Drug Safety)
Source: Drug Safety - November 27, 2020 Category: Drugs & Pharmacology Source Type: research

Frequency and Associated Costs of Anaphylaxis- and Hypersensitivity-Related Adverse Events for Intravenous Iron Products in the USA: An Analysis Using the US Food and Drug Administration Adverse Event Reporting System
ConclusionsReporting rates of hypersensitivity and anaphylaxis with intravenous iron preparations were highest with ferumoxytol and lowest with ferric carboxymaltose in the US FAERS database. Adverse event-related medical costs were highest for iron dextran and ferumoxytol, and lowest for ferric carboxymaltose. (Source: Drug Safety)
Source: Drug Safety - November 25, 2020 Category: Drugs & Pharmacology Source Type: research

How to Investigate a Serious Adverse Event Reported During a Clinical Trial for a COVID-19 Vaccine
(Source: Drug Safety)
Source: Drug Safety - November 21, 2020 Category: Drugs & Pharmacology Source Type: research

Changes in Erythropoiesis Stimulating Agent Use Under a Risk Evaluation and Mitigation Strategy (REMS) Program
ConclusionREMS program implementation and enforcement were not associated with significant changes in ESA initiation, adding to concerns over the degree to which certain REMS programs enhance patient safety. (Source: Drug Safety)
Source: Drug Safety - November 18, 2020 Category: Drugs & Pharmacology Source Type: research

Acknowledgement to Referees
(Source: Drug Safety)
Source: Drug Safety - November 18, 2020 Category: Drugs & Pharmacology Source Type: research

Efficacy and Safety of Bevacizumab Plus Oxaliplatin- or Irinotecan-Based Doublet Backbone Chemotherapy as the First-Line Treatment of Metastatic Colorectal Cancer: A Systematic Review and Meta-analysis
AbstractIntroduction and ObjectiveGuidelines recommend combined doublet backbone chemotherapy based on 5-fluorouracil and oxaliplatin (OX) or irinotecan (IR) as the first-line treatment options for metastatic colorectal cancer. However, it is still unknown which is better when combined with bevacizumab (BEV). This systematic review and meta-analysis were performed to compare BEV-IR with BEV-OX regimens in terms of efficacy and safety.MethodsWe searched studies from databases including MEDLINE, EMBASE, CENTRAL, and conference papers. The outcomes were overall response rate, overall survival, progression-free survival, and t...
Source: Drug Safety - November 12, 2020 Category: Drugs & Pharmacology Source Type: research