Identifying Safety Subgroups at Risk: Assessing the Agreement Between Statistical Alerting and Patient Subgroup Risk
ConclusionsWe observed low concordance between subgroup disproportionality scores and PRAC discussions of potential subgroup risk. Subgroup analyses performed better for age and sex, while for covariates not well-captured in FAERS, such as underlying condition and pregnancy, additional data sources should be considered. (Source: Drug Safety)
Source: Drug Safety - May 2, 2023 Category: Drugs & Pharmacology Source Type: research
The Effect of Metformin on Chemotherapy-Induced Toxicities in Non-diabetic Breast Cancer Patients: A Randomised Controlled Study
ConclusionMetformin offers a therapeutic opportunity for controlling toxicities caused by neoadjuvant chemotherapy in non-diabetic breast cancer patients.Trial RegistrationThis randomised controlled trial was registered on November 20, 2019 in ClinicalTrials.gov under registration number: NCT04170465. (Source: Drug Safety)
Source: Drug Safety - May 2, 2023 Category: Drugs & Pharmacology Source Type: research
Impact of Lifestyle and Socioeconomic Position on the Association Between Non-steroidal Anti-inflammatory Drug Use and Major Adverse Cardiovascular Events: A Case-Crossover Study
ConclusionsThe relative increase in cardiovascular risk associated with NSAID use was not modified by lifestyle or socioeconomic position. (Source: Drug Safety)
Source: Drug Safety - May 2, 2023 Category: Drugs & Pharmacology Source Type: research
Identifying Safety Subgroups at Risk: Assessing the Agreement Between Statistical Alerting and Patient Subgroup Risk
ConclusionsWe observed low concordance between subgroup disproportionality scores and PRAC discussions of potential subgroup risk. Subgroup analyses performed better for age and sex, while for covariates not well-captured in FAERS, such as underlying condition and pregnancy, additional data sources should be considered. (Source: Drug Safety)
Source: Drug Safety - May 2, 2023 Category: Drugs & Pharmacology Source Type: research
Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials
ConclusionsThe CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data. (Source: Drug Safety)
Source: Drug Safety - April 27, 2023 Category: Drugs & Pharmacology Source Type: research
Cardiovascular Toxicities Associated with Anaplastic Lymphoma Kinase Inhibitors: A Disproportionality Analysis of the WHO Pharmacovigilance Database (VigiBase)
ConclusionsSystematic evaluation of ALK inhibitor-associated adverse events revealed differences in the cardiotoxicity profiles among ALK inhibitors. Understanding the differences in the cardiovascular toxicity profile of each ALK inhibitor will contribute to safe drug therapy when switching between ALK inhibitors. (Source: Drug Safety)
Source: Drug Safety - April 27, 2023 Category: Drugs & Pharmacology Source Type: research
Authors ’ Reply to Braillon et al. ’s Comment on “Should Antidepressants be Avoided in Pregnancy?”
(Source: Drug Safety)
Source: Drug Safety - April 27, 2023 Category: Drugs & Pharmacology Source Type: research
Comment on: & quot;Should Antidepressants be Avoided in Pregnancy? & quot;
(Source: Drug Safety)
Source: Drug Safety - April 27, 2023 Category: Drugs & Pharmacology Source Type: research
Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials
ConclusionsThe CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data. (Source: Drug Safety)
Source: Drug Safety - April 27, 2023 Category: Drugs & Pharmacology Source Type: research
Cardiovascular Toxicities Associated with Anaplastic Lymphoma Kinase Inhibitors: A Disproportionality Analysis of the WHO Pharmacovigilance Database (VigiBase)
ConclusionsSystematic evaluation of ALK inhibitor-associated adverse events revealed differences in the cardiotoxicity profiles among ALK inhibitors. Understanding the differences in the cardiovascular toxicity profile of each ALK inhibitor will contribute to safe drug therapy when switching between ALK inhibitors. (Source: Drug Safety)
Source: Drug Safety - April 27, 2023 Category: Drugs & Pharmacology Source Type: research
Authors ’ Reply to Braillon et al. ’s Comment on “Should Antidepressants be Avoided in Pregnancy?”
(Source: Drug Safety)
Source: Drug Safety - April 27, 2023 Category: Drugs & Pharmacology Source Type: research
Comment on: & quot;Should Antidepressants be Avoided in Pregnancy? & quot;
(Source: Drug Safety)
Source: Drug Safety - April 27, 2023 Category: Drugs & Pharmacology Source Type: research
Prenatal exposure to pregabalin, birth outcomes and neurodevelopment – a population-based cohort study in four Nordic countries
ConclusionsPrenatal exposure to pregabalin was not associated with low birth weight, preterm birth, small for gestational age, low Apgar score, microcephaly, autism spectrum disorders, or intellectual disability. On the basis of the upper value of the 95% confidence interval, increased risks greater than 1.8 were unlikely for any major congenital malformation and ADHD. For stillbirth and most groups of specific major congenital malformations, the estimates attenuated in MH meta-analysis. (Source: Drug Safety)
Source: Drug Safety - April 26, 2023 Category: Drugs & Pharmacology Source Type: research
Facilitators and Barriers to Uptake of the Med Safety Mobile App for Adverse Drug Reaction Reporting by Health Workers in Uganda: A Qualitative Study
ConclusionThere was goodwill among the health workers to adopt Med Safety for ADR reporting and the majority would recommend the app to other health workers. Training with practice increased acceptability of the app and should be integral in all future app roll-out campaigns. The identified facilitators and barriers could be used to appropriately guide future research and implementation to promote the uptake of Med Safety for pharmacovigilance in low- and middle-income countries. (Source: Drug Safety)
Source: Drug Safety - April 25, 2023 Category: Drugs & Pharmacology Source Type: research
