Comparing the difference of adverse events with HER2 inhibitors: a study of the FDA adverse event reporting system (FAERS)

Bao, Yiwen; Chen, Jiaju; Duan, Luting; Wang, Fujue; Lai, Han; Mo, Zeming; Zhu, Weiliang

doi:10.3389/fphar.2024.1288362

Cited by 3 publications

(1 citation statement)

References 35 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Disproportionality analysis is now widely used in the monitoring of ADRs ( Bao et al, 2024 ). We used a four-grid proportional imbalance method for disproportionality analysis ( Supplementary Table S1 ).…”

Section: Methodsmentioning

confidence: 99%

Adverse event profile of memantine and donepezil combination therapy: a real-world pharmacovigilance analysis based on FDA adverse event reporting system (FAERS) data from 2004 to 2023

Yang,

Wei,

Tian

et al. 2024

Front. Pharmacol.

View full text Add to dashboard Cite

BackgroundDonepezil in combination with memantine is a widely used clinical therapy for moderate to severe dementia. However, real-world population data on the long-term safety of donepezil in combination with memantine are incomplete and variable. Therefore, the aim of this study was to analyze the adverse events (AEs) of donepezil in combination with memantine according to US Food and Drug Administration Adverse Event Reporting System (FAERS) data to provide evidence for the safety monitoring of this therapy.MethodsWe retrospectively analyzed reports of AEs associated with the combination of donepezil and memantine from 2004 to 2023 extracted from the FAERS database. Whether there was a significant association between donepezil and memantine combination therapy and AEs was assessed using four disproportionality analysis methods, namely, the reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker methods. To further investigate potential safety issues, we also analyzed differences and similarities in the time of onset and incidence of AEs stratified by sex and differences and similarities in the incidence of AEs stratified by age.ResultsOf the 2,400 adverse drug reaction (ADR) reports in which the combination of donepezil and memantine was the primary suspected drug, most of the affected patients were female (54.96%) and older than 65 years of age (79.08%). We identified 22 different system organ classes covering 100 AEs, including some common AEs such as dizziness and electrocardiogram PR prolongation; fall, pleurothotonus and myoclonus were AEs that were not listed on the drug label. Moreover, we obtained 88 reports of AEs in men and 100 reports of AEs in women; somnolence was a common AE in both men and women and was more common in women, whereas pleurothotonus was a more common AE in men. In addition, we analyzed 12 AEs in patients younger than 18 years, 16 in patients between 18 and 65 years, and 113 in patients older than 65 years. The three age groups had distinctive AEs, but lethargy was the common AE among all age groups. Finally, the median time to AE onset was 19 days in all cases. In both men and women, most AEs occurred within a month of starting donepezil plus memantine, but some continued after a year of treatment.ConclusionOur study identified potential and new AEs of donepezil in combination with memantine; some of these AEs were the same as in the specification, and some of the AE signals were not shown in the specification. In addition, there were sex and age differences in some of the AEs. Therefore, our findings may provide valuable insights for further studies on the safety of donepezil and memantine combination therapy, which are expected to contribute to the safe use of this therapy in clinical practice.

show abstract

Section: Methodsmentioning

confidence: 99%

Adverse event profile of memantine and donepezil combination therapy: a real-world pharmacovigilance analysis based on FDA adverse event reporting system (FAERS) data from 2004 to 2023

Yang,

Wei,

Tian

et al. 2024

Front. Pharmacol.

View full text Add to dashboard Cite

show abstract

Multidimensional assessment of adverse events of finasteride: a real-world pharmacovigilance analysis based on FDA Adverse Event Reporting System (FAERS) from 2004 to April 2024

Zhong,

Yang,

Wei

et al. 2024

Preprint

View full text Add to dashboard Cite

Background Finasteride is commonly utilized in clinical practice for treating androgenetic alopecia, but real-world data regarding the long-term safety of its adverse events remains incomplete, necessitating ongoing supplementation. This study aims to evaluate the adverse events (AEs) associated with finasteride use, based on data from the US Food and Drug Administration Adverse Event Reporting System (FAERS), to contribute to its safety assessment. Methods We reviewed adverse event reports associated with finasteride from the FAERS database, covering the period from the first quarter of 2004 to the first quarter of 2024. We assessed the safety of finasteride medication and AEs using four proportional disproportionality analyses: reported odds ratio, proportionate reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPN), and Multi-Item Gamma Poisson Shrinkage (MGPS). These methods were used to evaluate the of finasteride medication and AEs. whether there is a significant association between finasteride drug use and AEs. To investigate potential safety issues related to drug use, we further analyzed the similarities and differences in the onset time and AEs by gender, as well as the similarities and differences in AEs by age. Results Among the 11,557 adverse event reports where finasteride was the primary suspected drug, most patients affected were male (86.04%), with a significant proportion being the young adult aged 18-45 years (27.22%). We categorized 73 adverse events (AEs) into 7 different system organ categories (SOCs), which included common AEs like erectile dysfunction and sexual dysfunction. Notably, Peyronie's disease and post 5α reductase inhibitor syndrome were AEs not listed in the drug insert. We identified 102 AEs for men and 7 for women. Depression and anxiety were notable AEs for both male and female. Additionally, we examined 17 adverse events (AEs) in patients under 18 years old, 157 in patients aged 18 to 65 years, and 133 in patients aged 65 years and older. Each age group exhibited unique AEs, although erectile dysfunction, decreased libido, depression, suicidal ideation, psychotic disorder, and attention disturbance were common AEs observed across different age brackets. Ultimately, the median onset time for all instances was 61 days. The onset was mainly within one month after initiation of finasteride and it is noteworthy that the second highest number of cases involved adverse drug reactions persisted beyond one year of treatment. Conclusion The results of our study uncovered both known and novel AEs associated with finasteride medication. Some of these AEs were identical to the specification, and some of them signaled AEs that were not demonstrated in the specification. In addition, some AEs showed variations based on gender and age in our study. Consequently, our findings offer valuable insights for future research on the safety of finasteride medication and are anticipated to enhance its safe use in clinical practice.

show abstract

An exploratory study evaluating the 20 medications most commonly associated with suicidal ideation and self-injurious behavior in the FAERS database

Xie,

Xiang,

et al. 2024

Preprint

View full text Add to dashboard Cite

A number of pharmaceuticals, including antidepressants and antiepileptics, have a strong correlation with suicide risk. However few studies based on real-world data have been published. This study aims to investigates the correlation between certain pharmaceuticals and the risk of suicidal ideation or self-injurious behavior. Utilizing the FDA Adverse Event Reporting System (FAERS) database, we conducted an analysis to identify drugs linked to these adverse outcomes, employing the High-Level Term (HLT) classification from the MedDRA dictionary. By assessing the reporting intensity of the HLT "suicidal ideation or self-injurious behavior" and its Preferred Terms (PTs) across various drug categories with the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR), we pinpointed the top 20 medications with the highest association. These included sedative-hypnotics, antidepressants, antipsychotics, antiepileptic drugs, antihypertensives, antipyretics/analgesics, and antihyperglycemics. Ranking by ROR, the drugs with the strongest association were alprazolam, zolpidem, bupropion, quetiapine, and fluoxetine. Different categories of drugs are on the table for various reasons. This study provides a nuanced and scientifically rigorous examination of the link between diverse drug categories and the reporting frequency of suicide and self-injury, presenting valuable information for improved medication management and patient safety.

show abstract

Comparing the difference of adverse events with HER2 inhibitors: a study of the FDA adverse event reporting system (FAERS)

Cited by 3 publications

References 35 publications

Adverse event profile of memantine and donepezil combination therapy: a real-world pharmacovigilance analysis based on FDA adverse event reporting system (FAERS) data from 2004 to 2023

Adverse event profile of memantine and donepezil combination therapy: a real-world pharmacovigilance analysis based on FDA adverse event reporting system (FAERS) data from 2004 to 2023

Multidimensional assessment of adverse events of finasteride: a real-world pharmacovigilance analysis based on FDA Adverse Event Reporting System (FAERS) from 2004 to April 2024

An exploratory study evaluating the 20 medications most commonly associated with suicidal ideation and self-injurious behavior in the FAERS database

Contact Info

Product

Resources

About