A Descriptive Analysis of Direct Oral Anticoagulant Drugs Dosing Errors Based on Spontaneous Reports from the EudraVigilance Database

Morgovan, Claudiu; Dobrea, Carmen Maximiliana; Chiș, Adriana Aurelia; Juncan, Anca Maria; Arseniu, Anca Maria; Rus, Luca Liviu; Gligor, Felicia Gabriela; Ardelean, Simona; Stoicescu, L.; Ghibu, Stéliana; Frum, Adina

doi:10.3390/ph16030455

Cited by 5 publications

(2 citation statements)

References 53 publications

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“…In the present study, 4 HLT were identified (modified dose, overdose, underdose, and off-label use) [42,44]. Thus, of a total of 35 Preferred terms (PTs), only 27 were identified in ICSRs uploaded for the evaluated drugs (Table 1).…”

Section: Methodsmentioning

confidence: 99%

An Assessment of Semaglutide Safety Based on Real World Data: From Popularity to Spontaneous Reporting in EudraVigilance Database

Butuca,

Dobrea,

Arseniu

et al. 2024

Preprint

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Some glucagon-like peptide-1 receptor agonists (GLP-1 RAs), first used in the treat-ment of type 2 diabetes mellitus (T2DM), have been approved for the treatment of obe-sity in patients with or without T2DM (liraglutide – LIR, semaglutide - SEM, and tir-zepatide - TIR). Social media had an important influence on the off-label use of GLP-1 RAs for obesity, especially for SEM. We analysed the Google queries related to SEM to assess people's interest in this drug. We also investigated the occurrence of adverse drug reactions (ADRs) by searching the EudraVigilance database (EV) for Individual Case Safety Reports (ICSRs) that reported SEM as the suspected drug and performed a descriptive and a disproportionality analysis. Data obtained for SEM were compared to other GLP-1 RAs. SEM had the highest proportions of searches on Google associated with the term “weight loss” and presented the lowest number of severe ADRs, but it also had the highest number of ICSRs reported in EV. Even though no unexpected safety issues have been reported for it until now, SEM has a high tendency for overdose reports. The most frequent off-label use was reported for SEM and TIR. In order to lower the ADRs’ risks, the off-label use should be reduced and carefully monitored.

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Section: Methodsmentioning

confidence: 99%

An Assessment of Semaglutide Safety Based on Real World Data: From Popularity to Spontaneous Reporting in EudraVigilance Database

Butuca,

Dobrea,

Arseniu

et al. 2024

Preprint

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show abstract

“…Subsequently, a comparison was performed between both T-based ADCs (T-DM1 and T-DXd) to evaluate their similarities and differences related to the reporting probability for all ADRs tested. To establish the disproportionate signal, reporting odds ratio (ROR) and 95% confidence intervals (CI) [34] were calculated with MedCalc Software Ltd. Odds ratio calculator [35]; https://www.medcalc.org/calc/odds_ratio.php (Version 20.123), accessed on 26 February 2024.…”

Section: Disproportionality Analysismentioning

confidence: 99%

Safety Profile of the Trastuzumab-Based ADCs: Analysis of Real-World Data Registered in EudraVigilance

Morgovan,

Dobrea,

Butuca

et al. 2024

Biomedicines

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Trastuzumab (T) and tyrosine kinase inhibitors (TKIs) are among the first-line treatments recommended for HER2-positive breast cancer. More recently, antibody-drug conjugates (ADCs) such as trastuzumab deruxtecan (T-DXd) and trastuzumab emtansine (T-DM1) have been authorized, and they represent the second-line therapy in this type of cancer. The present study aimed to evaluate adverse drug reactions (ADRs) associated with T-based ADCs that were spontaneously reported in EudraVigilance—the European pharmacovigilance database. Out of 42,272 ADRs reported for currently approved ADCs on the market, 24% of ADRs were related to T-DM1, while 12% of ADRs were related to T-DXd. T-DM1 had a higher probability of reporting eye, ear and labyrinth, and cardiac and hepatobiliary ADRs, while T-DXd had a higher probability of reporting respiratory, thoracic and mediastinal, blood and lymphatic system, metabolism and nutrition, and gastrointestinal ADRs. The present research found that in terms of hematological disorders, T-DM1 and T-DXd had a higher probability of reporting ADRs than TKIs. Moreover, the data showed that T-DM1 seemed to have a higher risk of cardiotoxicity than T-DXd, while T-DXd had a higher probability of reporting metabolism and nutrition disorders than T-DM1.

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Direct Oral Anticoagulants: Patients Benefit When Prescribers Get the Message

Naccarelli

2023

The American Journal of Cardiology

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A Descriptive Analysis of Direct Oral Anticoagulant Drugs Dosing Errors Based on Spontaneous Reports from the EudraVigilance Database

Cited by 5 publications

References 53 publications

An Assessment of Semaglutide Safety Based on Real World Data: From Popularity to Spontaneous Reporting in EudraVigilance Database

An Assessment of Semaglutide Safety Based on Real World Data: From Popularity to Spontaneous Reporting in EudraVigilance Database

Safety Profile of the Trastuzumab-Based ADCs: Analysis of Real-World Data Registered in EudraVigilance

Direct Oral Anticoagulants: Patients Benefit When Prescribers Get the Message

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