Evaluation of rivaroxaban-, apixaban- and dabigatran-associated hemorrhagic events using the FDA-Adverse event reporting system (FAERS) database

Guo, Mengping; Thai, Sydney; Zhou, Junwen; Wei, Jingkai; Zhao, Ying; Xu, Wanyi; Wang, Tiansheng; Cui, Xiangli

doi:10.1007/s11096-021-01273-8

Cited by 4 publications

(4 citation statements)

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“…First, we performed a disproportionality analysis to evaluate the association between periostitis and triazole antifungals. Next, considering that the risks of periostitis in different sex and age groups were unclear, we performed subgroup analyses by sex (male and female) and age groups (< 18 years old, 18-65 years old, and > 65 years old) [33][34][35][36] . "a" is the number of reports with adverse events of interest of the drugs of interest, "b" is the number of reports with adverse events of interest of all other drugs, "c" is the number of reports with all other adverse events of the drugs of interest, and "d" is the number of reports with all other adverse events of all other drugs.…”

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Using disproportionality analysis to explore the association between periostitis and triazole antifungals in the FDA Adverse Event Reporting System Database

Zhang

Jiao

et al. 2023

Sci Rep

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Though triazole antifungals are the first choice for preventing and treating invasive fungal infections, periostitis caused by voriconazole has been described in emerging case reports; however, no studies exist on this association in real-world clinical settings. Our study aimed to identify the association between periostitis and triazole antifungals by analyzing data from the FDA Adverse Event Reporting System (FAERS). We extracted and analyzed reports on the association between periostitis and triazole antifungals in FAERS from the first quarter of 2004 to the second quarter of 2022 using OpenVigil 2.1. Disproportionality analysis was performed to evaluate the association between periostitis and triazole antifungals, and chi-squared (χ2), relative reporting ratio (RRR), reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural networks (BCPNN) of information components (IC) were reported. In total, 143 patients experienced periostitis while using voriconazole. Disproportionality analysis identified an association between periostitis and voriconazole (χ2 = 82,689.0, RRR = 583.6, 95%CI [472.4, 721.1], PRR = 1808.9, 95%CI [1356.0, 2412.9], ROR = 1831.7, 95%CI [1371.6, 2446.3], IC = 9.2, 95%CI [8.6, 9.8]). However, no safety signals were observed between periostitis and other triazole antifungals. When stratified by sex and age, disproportionality analysis identified positive signals between periostitis and voriconazole. The possible association between periostitis and voriconazole should attract sufficient attention in clinical practice. Alternative treatment with other triazole antifungals can be considered, and causality needs to be verified in further prospective studies.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Using disproportionality analysis to explore the association between periostitis and triazole antifungals in the FDA Adverse Event Reporting System Database

Zhang

Jiao

et al. 2023

Sci Rep

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“…For this analysis the ratio of the number of reports for the four haemodynamic effects to the number of reports for any other event with carbetocin formed the numerator, while the ratio of the number of reports for the four haemodynamic effects to the number of reports for any other event with oxytocin formed the denominator. This calculation allowed for a direct comparison between the two uterotonics, similar to the disproportionality analysis for haemorrhagic events during treatment with different non-vitamin K antagonist oral anticoagulants by Guo and colleagues [ 15 ]. When the 95%CI includes 1.00, no clear effect can be interpreted, and the result must be rejected as statistically not significant.…”

Section: Methodsmentioning

confidence: 99%

An explorative analysis of pharmacovigilance data of oxytocin and its analogue carbetocin, with a focus on haemodynamic adverse effects

Stämpfli,

Dommrich,

Orbach-Zinger

et al. 2023

Int J Clin Pharm

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Background Oxytocin and its analogue carbetocin are uterotonics whose prophylactic use is recommended to prevent postpartum haemorrhage, which is one of the leading causes of maternal deaths worldwide. However, both drugs can cause specific adverse effects and haemodynamic challenges. Aim The aim of this work was to exploratively examine reports of adverse drug events of both drugs and to establish a comparative haemodynamic profile. Method Using data extracted from the World Health Organization’s pharmacovigilance database VigiBase, a descriptive analysis was performed of all reports for oxytocin and carbetocin as a suspected or interacting drug followed by a disproportionality analysis for haemodynamic events. Reporting odds ratios (ROR) of carbetocin for hypertension, hypotension, tachycardia, and bradycardia were calculated, with oxytocin-related reports serving as comparators. Results Oxytocin and carbetocin were mentioned as suspected or interacting drugs in 11,258 and 374 reports, respectively. Resulting RORs for carbetocin were 3.45 (95%CI: 1.72–6.92) for hypertension, 2.65 (1.64–4.28) for hypotension, 2.84 (1.79–4.49) for tachycardia, and 2.00 (0.87–4.60) for bradycardia, when compared to oxytocin. Of 231 patients for whom oxytocin-related tachycardia was reported, 2.6% died, and of 91 patients for whom bradycardia was reported, 2.2% died. No deaths were reported with carbetocin for any of the haemodynamic adverse events. Conclusion Compared to oxytocin, carbetocin showed an elevated reporting for adverse hypertension, hypotension, and tachycardia in pharmacovigilance data. Clinicians should be aware of their patients' individual susceptibility and the possibility of haemodynamic deterioration until causal inferences are possible.

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“…A signal of increased AE risk was defined as ROR value higher than 2, with the number of cases higher than 3, lower limit of 95% confidence interval (CI) greater than 1, and Chi square value higher than 4 ( Sakaeda et al, 2013 ). ROR between one and two was considered as a moderate signal ( Guo et al, 2021 ). An ROR value lower than one was deemed not to indicate a potential safety signal.…”

Section: Methodsmentioning

confidence: 99%

Adverse Events During Pregnancy Associated With Entecavir and Adefovir: New Insights From a Real-World Analysis of Cases Reported to FDA Adverse Event Reporting System

et al. 2022

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Background: Due to the embryotoxicity found in animal studies and scarce clinical data in pregnant women, it is still controversial whether entecavir (ETV) and adefovir dipivoxil (ADV) are safe during human pregnancy. This is of paramount importance when counseling pregnant women with hepatitis B virus (HBV) on risks and benefits to their offspring.Objective: To quantify the association between administration of ETV and ADV in pregnant women and occurrence of adverse events (AEs) during pregnancy (AEDP).Methods: Pregnancy reports from the FDA Adverse Event Reporting System (FAERS) were used to perform a retrospective analysis of AEDP associated with ETV or ADV. Disproportionality analysis estimating the reporting odds ratio (ROR) was conducted to identify the risk signals. A signal was defined as ROR value >2, and lower limit of 95% confidence interval (CI)> 1.Results: A total of 1,286,367 reports involving AEDP were submitted to FAERS by healthcare professionals. Of these, there were 547 cases reporting ETV and 242 cases reporting ADV as primary suspected drugs. We found a moderate or strong signal for increased risk of spontaneous abortion when comparing ETV with tenofovir disoproxil fumarate (TDF) and telbivudine (LdT), with RORs equal to 1.58 (95% CI, 1.09–2.30) and 2.13 (95% CI, 1.04–4.36), respectively. However, when the included reports were limited to indication containing HBV infection, no signals for increased AEDP were detected. Futhermore, a strong signal for increased risk of spontaneous abortion was identified in patients with HBV infection when comparing ETV or ADV with lamivudine (LAM), with RORs of 3.55 (95% CI, 1.54–8.18) and 2.85 (95% CI, 1.15–7.08), respectively.Conclusion: We found a strong signal for increased risk of spontaneous abortion in patients with HBV infection taking ETV or ADV, in comparison with those prescribed with LAM. Moreover, no obvious signal association of human teratogenicity with exposure to ETV or ADV was identified in fetuses during pregnancy. Nevertheless, owing to the limitations of a spontaneous reporting database, which inevitably contains potential biases, there is a pressing need for well-designed comparative safety studies to validate these results in clinical practice.

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Evaluation of rivaroxaban-, apixaban- and dabigatran-associated hemorrhagic events using the FDA-Adverse event reporting system (FAERS) database

Cited by 4 publications

References 24 publications

Using disproportionality analysis to explore the association between periostitis and triazole antifungals in the FDA Adverse Event Reporting System Database

Using disproportionality analysis to explore the association between periostitis and triazole antifungals in the FDA Adverse Event Reporting System Database

An explorative analysis of pharmacovigilance data of oxytocin and its analogue carbetocin, with a focus on haemodynamic adverse effects

Adverse Events During Pregnancy Associated With Entecavir and Adefovir: New Insights From a Real-World Analysis of Cases Reported to FDA Adverse Event Reporting System

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