Comparative Safety Surveillance of Triple (IDA) Versus Dual Therapy (DA) in Mass Drug Administration for Elimination of Lymphatic Filariasis in Kenya: A Cohort Event Monitoring Study
ConclusionsIvermectin, diethylcarbamazine, and albendazole as a combination is as safe and well tolerated as DA to use in MDA campaigns with no serious life-threatening adverse events. Systemic mild-to-moderate adverse events with a few severe cases and transient adverse events are more common with IDA treatment than with DA treatment. Hence, integrating pharmacovigilance into a MDA program is recommended for the timely detection and management of adverse events. (Source: Drug Safety)
Source: Drug Safety - August 8, 2023 Category: Drugs & Pharmacology Source Type: research
Clinical Guidance on the Monitoring and Management of Trastuzumab Deruxtecan (T-DXd)-Related Adverse Events: Insights from an Asia-Pacific Multidisciplinary Panel
AbstractTrastuzumab deruxtecan (T-DXd) —an antibody–drug conjugate targeting the human epidermal growth factor receptor 2 (HER2)—improved outcomes of patients with HER2-positive and HER2-low metastatic breast cancer. Guidance on monitoring and managing T-DXd–related adverse events (AEs) is an emerging unmet need as translating cl inical trial experience into real-world practice may be difficult due to practical and cultural considerations and differences in health care infrastructure. Thus, 13 experts including oncologists, pulmonologists and a radiologist from the Asia-Pacific region gathered to provide recommenda...
Source: Drug Safety - August 8, 2023 Category: Drugs & Pharmacology Source Type: research
Comparative Safety Surveillance of Triple (IDA) Versus Dual Therapy (DA) in Mass Drug Administration for Elimination of Lymphatic Filariasis in Kenya: A Cohort Event Monitoring Study
ConclusionsIvermectin, diethylcarbamazine, and albendazole as a combination is as safe and well tolerated as DA to use in MDA campaigns with no serious life-threatening adverse events. Systemic mild-to-moderate adverse events with a few severe cases and transient adverse events are more common with IDA treatment than with DA treatment. Hence, integrating pharmacovigilance into a MDA program is recommended for the timely detection and management of adverse events. (Source: Drug Safety)
Source: Drug Safety - August 8, 2023 Category: Drugs & Pharmacology Source Type: research
Clinical Guidance on the Monitoring and Management of Trastuzumab Deruxtecan (T-DXd)-Related Adverse Events: Insights from an Asia-Pacific Multidisciplinary Panel
AbstractTrastuzumab deruxtecan (T-DXd) —an antibody–drug conjugate targeting the human epidermal growth factor receptor 2 (HER2)—improved outcomes of patients with HER2-positive and HER2-low metastatic breast cancer. Guidance on monitoring and managing T-DXd–related adverse events (AEs) is an emerging unmet need as translating cl inical trial experience into real-world practice may be difficult due to practical and cultural considerations and differences in health care infrastructure. Thus, 13 experts including oncologists, pulmonologists and a radiologist from the Asia-Pacific region gathered to provide recommenda...
Source: Drug Safety - August 8, 2023 Category: Drugs & Pharmacology Source Type: research
Finding Needles in the Haystack: Clinical Utility Score for Prioritisation (CUSP), an Automated Approach for Identifying Spontaneous Reports with the Highest Clinical Utility
ConclusionAlthough several tools have been developed to assess ICSR completeness and regulatory utility, this is the first attempt to successfully develop an automated clinical utility scoring system that can support the prioritisation of ICSRs for clinical review. (Source: Drug Safety)
Source: Drug Safety - August 3, 2023 Category: Drugs & Pharmacology Source Type: research
Use of Bisphosphonates and the Risk of Skin Ulcer: A National Cohort Study Using Data from the French Health Care Claims Database
ConclusionNo association between bisphosphonate and skin ulcers was found in the French population. The association observed in previous pharmacovigilance studies and in the Cox regression analysis is likely due to unmeasured confounding factors. (Source: Drug Safety)
Source: Drug Safety - August 2, 2023 Category: Drugs & Pharmacology Source Type: research
The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls
ConclusionsQTc-Bazett intervals are not significantly different between former preterm and/or ELBW cases and term-born controls, and we rejected a potential prolongation> 10 ms in cases. When prescribing QTc-prolonging drugs, pharmacovigilance practices in this subpopulation should be similar to the general public (NCT05243537). (Source: Drug Safety)
Source: Drug Safety - July 28, 2023 Category: Drugs & Pharmacology Source Type: research
Managing Cardiovascular and Cancer Risk Associated with JAK Inhibitors
AbstractJanus kinase inhibitors (JAKi) have enormous appeal as immune-modulating therapies across many chronic inflammatory diseases, but recently this promise has been overshadowed by questions regarding associated cardiovascular and cancer risk emerging from the ORAL Surveillance phase 3b/4 post-marketing requirement randomized controlled trial. In that study of patients with rheumatoid arthritis with existing cardiovascular risk, tofacitinib, the first JAKi registered for chronic inflammatory disease, failed to meet non-inferiority thresholds when compared with tumor necrosis factor inhibitors for both incident major ad...
Source: Drug Safety - July 25, 2023 Category: Drugs & Pharmacology Source Type: research
Mapping Strategies to Assess and Increase the Validity of Published Disproportionality Signals: A Meta-Research Study
ConclusionsThis meta-research study highlighted the heterogeneity in methods and strategies used by researchers to assess the validity of disproportionality signals. Mapping these strategies is a first step towards testing their utility in different scenarios and developing guidelines for designing future disproportionality analysis. (Source: Drug Safety)
Source: Drug Safety - July 8, 2023 Category: Drugs & Pharmacology Source Type: research
Disproportionality Analysis of Abemaciclib in the FDA Adverse Event Reporting System: A Real-World Post-Marketing Pharmacovigilance Assessment
ConclusionsThe discovery of disproportionality signals could potentially prompt improved awareness of toxicities for abemaciclib, and the results of time to onset, serious and non-serious reports, and clinical priority analyses provided some supporting evidence for clinicians to manage adverse events. (Source: Drug Safety)
Source: Drug Safety - July 7, 2023 Category: Drugs & Pharmacology Source Type: research
