Risk of Bleeding Associated with Antidepressant Drugs: The Competitive Impact of Antithrombotics in Quantitative Signal Detection

Zeiss, René; Hiemke, Christoph; Schönfeldt‐Lecuona, Carlos; Connemann, Bernhard J.; Gahr, Maximilian

doi:10.1007/s40801-021-00260-9

Cited by 3 publications

(2 citation statements)

References 44 publications

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“…In a previous analysis, where we only analyzed causally linked drug/event-reports, we could not detect a significant number of signals, meaning that we were not able to demonstrate the well-known bleeding risk related to ADs (25). By contrast, in the present study, where we assessed ICSRs categorized as "suspected/interacting/concomitant, " we found several signals concerning bleeding in general, gastrointestinal bleeding, and upper gastrointestinal bleeding.…”

Section: Effects Of Different Types Of Association Of Drug/event Reports On Signal Detectioncontrasting

confidence: 93%

Risk of Bleeding Associated With Antidepressants: Impact of Causality Assessment and Competition Bias on Signal Detection

et al. 2021

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Introduction: Until now, methods of pharmacovigilance as disproportionality analysis were not capable of proving the otherwise well-established increased bleeding risk related to antidepressants (ADs). As bleeding events with ADs often occur in combination with antithrombotics, they might not be considered causative of, but merely “linked” with, the bleeding event. Therefore, we hypothesized that the causality assessment of bleeding events in association with ADs and the competitive impact of antithrombotics are factors contributing to the non-findings of previous pharmacovigilance studies.Methods: We performed a case/non-case study based on data from VigiBaseTM and calculated reporting odds ratios (RORs) for 25 ADs. We used individual case safety reports (ICSRs) that were differently categorized in the database regarding their type of association between drug and event. Furthermore, we investigated the competitive impact of antithrombotics by comparing RORs with and without ICSRs related to antithrombotics.Results: Analysis of ICSRs that were categorized as causally associated resulted in the detection of only two signals (citalopram and escitalopram; upper gastrointestinal bleeding). Analysis of ICSRs irrespective of the type of association resulted in the detection of signals in 8 out of 25 ADs (regarding bleeding, in general, gastrointestinal bleeding and upper gastrointestinal bleeding). Consideration of ICSRs associated with antithrombotics as competitive substances did not have a major impact on signal detection in our analysis.Conclusion: Categorization of the type of association between drug and event affects the results of quantitative signal detection. Causality assessment seems to play a major role in signal detection, probably particularly concerning rare, unknown, or clinically insignificant adverse drug reactions. ADs appear to significantly increase the bleeding risk, even independent of antithrombotic comedication.

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Section: Effects Of Different Types Of Association Of Drug/event Reports On Signal Detectioncontrasting

confidence: 93%

Risk of Bleeding Associated With Antidepressants: Impact of Causality Assessment and Competition Bias on Signal Detection

et al. 2021

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“… Peripheral effects of acting on serotonin receptors and therapeutic outcomes [ 111 , 112 , 113 , 114 ]. …”

Section: Figurementioning

confidence: 99%

The Role of Serotonin Neurotransmission in Gastrointestinal Tract and Pharmacotherapy

Guzel

Mirowska‐Guzel

2022

Molecules

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5-Hydroxytryptamine (5-HT, serotonin) is a neurotransmitter in both the central nervous system and peripheral structures, acting also as a hormone in platelets. Although its concentration in the gut covers >90% of all organism resources, serotonin is mainly known as a neurotransmitter that takes part in the pathology of mental diseases. Serotonin modulates not only CNS neurons, but also pain transmission and platelet aggregation. In the periphery, 5-HT influences muscle motility in the gut, bronchi, uterus, and vessels directly and through neurons. Serotonin synthesis starts from hydroxylation of orally delivered tryptophan, followed by decarboxylation. Serotonin acts via numerous types of receptors and clinically plays a role in several neural, mental, and other chronic disorders, such as migraine, carcinoid syndrome, and some dysfunctions of the alimentary system. 5-HT acts as a paracrine hormone and growth factor. 5-HT receptors in both the brain and gut are targets for drugs modifying serotonin neurotransmission. The aim of the present article is to review the 5-HT receptors in the gastrointestinal (GI) tract to determine the role of serotonin in GI physiology and pathology, including known GI diseases and the role of serotonin in GI pharmacotherapy.

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Selective Serotonin Reuptake Inhibitor (SSRI) Bleeding Risk: Considerations for the Consult-Liaison Psychiatrist

McFarland

Merchant

Khandai

et al. 2023

Curr Psychiatry Rep

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Risk of Bleeding Associated with Antidepressant Drugs: The Competitive Impact of Antithrombotics in Quantitative Signal Detection

Cited by 3 publications

References 44 publications

Risk of Bleeding Associated With Antidepressants: Impact of Causality Assessment and Competition Bias on Signal Detection

Risk of Bleeding Associated With Antidepressants: Impact of Causality Assessment and Competition Bias on Signal Detection

The Role of Serotonin Neurotransmission in Gastrointestinal Tract and Pharmacotherapy

Selective Serotonin Reuptake Inhibitor (SSRI) Bleeding Risk: Considerations for the Consult-Liaison Psychiatrist

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