The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration

Fusaroli, Michele; Salvo, Francesco; Begaud, Bernard; AlShammari, Thamir M.; Bate, Andrew; Battini, Vera; Brueckner, Andreas; Candore, Gianmario; Carnovale, Carla; Crisafulli, Salvatore; Cutroneo, Paola Maria; Dolladille, Charles; Drici, Milou-Daniel; Faillie, Jean-Luc; Goldman, Adam; Hauben, Manfred; Herdeiro, Maria Teresa; Mahaux, Olivia; Manlik, Katrin; Montastruc, François; Noguchi, Yoshihiro; Norén, G. Niklas; Noseda, Roberta; Onakpoya, Igho J.; Pariente, Antoine; Poluzzi, Elisabetta; Salem, Myriam; Sartori, Daniele; Trinh, Nhung T. H.; Tuccori, Marco; van Hunsel, Florence; van Puijenbroek, Eugène; Raschi, Emanuel; Khouri, Charles

doi:10.1007/s40264-024-01423-7

Cited by 14 publications

(1 citation statement)

References 78 publications

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“…However, the study has its limitations. Disproportionality analysis only establishes a statistical association between drug usage and AEs and does not confirm a causal relationship between the drug and the adverse drug event (ADE) because the lack of details about patient exposure, reporting biases and confounding biases ( Zhou et al, 2022 ; Li et al, 2023 ; Fusaroli et al, 2024 ). Moreover, there are phenomena such as underreporting, incomplete case information, duration of use and dosage cannot be considered when analyzing the association between drugs and AEs.…”

Section: Discussionmentioning

confidence: 99%

Evaluating drug withdrawal syndrome risks through food and drug administration adverse event reporting system: a comprehensive disproportionality analysis

Zhang,

Yang,

Chen

et al. 2024

Front. Pharmacol.

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ObjectiveThe study aims to identify the drugs associated with drug withdrawal syndrome in the Food and Drug Administration Adverse Event Reporting System (FAERS) and estimate their risks of causing withdrawal syndrome.MethodsAll the data were collected from FAERS from the first quarter of 2004 to the third quarter of 2023. Disproportionality analyses of odds ratio (ROR) and proportional reported ratio were conducted to identify potential adverse effects signal of drug withdrawal syndrome.ResultsA total of 94,370 reports related to withdrawal syndrome from the data. The top 50 drugs with most frequency reported were analyzed, and 29 exhibited a positive signal based on the number of reports. The top three categories of drugs with positive signals included opioids, antidepressant drugs and antianxiety drugs. Other classifications included opioid antagonist, muscle relaxant, antiepileptic drugs, analgesics, hypnotic sedative drugs and antipsychotic drugs.ConclusionOur analysis of FAERS data yielded a comprehensive list of drugs associated with withdrawal syndrome. This information is vital for healthcare professionals, including doctors and pharmacists, as it aids in better recognition and management of withdrawal symptoms in patients undergoing treatment with these medications.

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Section: Discussionmentioning

confidence: 99%

Evaluating drug withdrawal syndrome risks through food and drug administration adverse event reporting system: a comprehensive disproportionality analysis

Zhang,

Yang,

Chen

et al. 2024

Front. Pharmacol.

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GLP-1 Receptor Agonists and Suicidality—Caution Is Needed

Salvo,

Faillie

2024

JAMA Netw Open

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Disproportionality Analysis From World Health Organization Data on Semaglutide, Liraglutide, and Suicidality

Schoretsanitis,

Weiler,

Barbui

et al. 2024

JAMA Netw Open

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ImportanceGlucagon-like peptide-1 receptor agonists (GLP-1 RAs) have gained use primarily due to their weight-reduction effects, although a regulatory review was undertaken for potential suicidality concern.ObjectivesTo evaluate potential signals for suicidal and self-injurious adverse drug reactions (ADRs) associated with the GLP-1 RAs semaglutide and liraglutide.Design, Setting, and ParticipantsDisproportionality analysis through the case-control design using the World Health Organization (WHO) global database of suspected ADRs. Participants were clinical patients worldwide experiencing an ADR suspectedly attributable to semaglutide or liraglutide in the database from inception to August 30, 2023. Data were analyzed from September to December 2023.ExposureTreatment with semaglutide or liraglutide regardless of indication or treatment duration.Main Outcomes and MeasuresReporting odds ratio (ROR) and the bayesian information component (IC) with 95% CIs were calculated as measures of disproportionate reporting of suicidal and self-injurious ADRs associated with semaglutide and liraglutide compared with all other medications. Sensitivity analyses were conducted including patients with coreported use of antidepressants and benzodiazepines and using dapagliflozin, metformin, and orlistat as comparators. A disproportionality signal was considered when the lower limits of the ROR and IC were above 1 and 0, respectively.ResultsA total of 107 (median [IQR] age 48 [40-56] years; 59 female patients [55%]) and 162 (median [IQR] age 47 [38-60] years; 100 female patients [61%]) cases of suicidal and/or self-injurious ADRs were reported between November 2000 and August 2023 with semaglutide and liraglutide, respectively. Significant disproportionality was detected only for semaglutide-associated suicidal ideation (ROR, 1.45; 95% CI, 1.18-1.77; IC, 0.53; 95% CI, 0.19-0.78), which remained significant in patients with coreported use of antidepressants (ROR, 4.45; 95% CI, 2.52-7.86; IC, 1.96; 95% CI, 0.98-2.63) and benzodiazepines (ROR, 4.07; 95% CI, 1.69-9.82; IC, 1.67; 95% CI, 0.11-2.65), when compared with dapagliflozin (ROR, 5.56; 95% CI, 3.23-9.60; IC, 0.70; 95% CI, 0.36-0.95), metformin (ROR, 3.86; 95% CI, 2.91-5.12; IC, 1.20; 95% CI, 0.94-1.53) and orlistat (ROR, 4.24; 95% CI, 2.69-6.69; IC, 0.70; 95% CI, 0.36-0.95).Conclusions and RelevanceThis study using the WHO database found a signal of semaglutide-associated suicidal ideation, which warrants urgent clarification.

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The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration

Cited by 14 publications

References 78 publications

Evaluating drug withdrawal syndrome risks through food and drug administration adverse event reporting system: a comprehensive disproportionality analysis

Evaluating drug withdrawal syndrome risks through food and drug administration adverse event reporting system: a comprehensive disproportionality analysis

GLP-1 Receptor Agonists and Suicidality—Caution Is Needed

Disproportionality Analysis From World Health Organization Data on Semaglutide, Liraglutide, and Suicidality

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