Bleeding adverse drug reactions (ADRs) in patients exposed to antiplatelet plus serotonin reuptake inhibitor drugs: analysis of the French Spontaneous Reporting Database for a controversial ADR

Maschino, Franck; Hurault‐Delarue, Caroline; Chebbane, Leila; Fabry, Vincent; Montastruc, J. L.; Bagheri, Haleh

doi:10.1007/s00228-012-1268-8

Cited by 12 publications

(8 citation statements)

References 24 publications

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“…This was demonstrated in the pharmacovigilance database study that showed no significant association between bleedings and exposure to SADs plus antiplatelet agents versus antiplatelet agents alone. 23 However, contrary to this thought, published studies have reported an increased bleeding risk associated with the addition of SADs to antiplatelet agents following myocardial infarction. 24 These differences may be attributed to the differences in the pharmacological properties of different SADs with regard to their affinity for the serotonin transporter, their inhibitory action on the CYP enzymes metabolising other drugs with bleeding risk (antiplatelets and anticoagulants), the dose of SADs used and their ability to compete for the CYP enzyme, at the substrate level.…”

Section: Discussionmentioning

confidence: 94%

“…Consequently, the additional effect of SADs on platelets in patients who are receiving long‐term potent antiplatelet therapy prior to surgery is negligible to have an impact on clinically important bleeding outcomes. This was demonstrated in the pharmacovigilance database study that showed no significant association between bleedings and exposure to SADs plus antiplatelet agents versus antiplatelet agents alone . However, contrary to this thought, published studies have reported an increased bleeding risk associated with the addition of SADs to antiplatelet agents following myocardial infarction .…”

Section: Discussionmentioning

confidence: 94%

See 1 more Smart Citation

Influence of pre‐operative use of serotonergic antidepressants (SADs) on the risk of bleeding in patients undergoing different surgical interventions: a meta‐analysis

Singh

Achuthan

Chakrabarti

et al. 2014

Pharmacoepidemiology and Drug

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Section: Discussionmentioning

confidence: 94%

Section: Discussionmentioning

confidence: 94%

Influence of pre‐operative use of serotonergic antidepressants (SADs) on the risk of bleeding in patients undergoing different surgical interventions: a meta‐analysis

Singh

Achuthan

Chakrabarti

et al. 2014

Pharmacoepidemiology and Drug

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“…461 Moreover, when used alongside APAs, perioperative use of SSRIs should be individualised. Although a French database analysis did not demonstrate any significant association between bleeding adverse drug reactions and exposure to SSRI and APAs versus APAs alone, 462 another database analysis found a high rate of adverse reactions of SSRIs related to drug-drug interactions. 463 Some SSRIs may interfere with warfarin metabolism and increase INR.…”

Section: Recommendationmentioning

confidence: 85%

Management of severe perioperative bleeding

Kozek‐Langenecker

Ahmed

Afshari

et al. 2017

European Journal of Anaesthesiology

677

316

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: The management of perioperative bleeding involves multiple assessments and strategies to ensure appropriate patient care. Initially, it is important to identify those patients with an increased risk of perioperative bleeding. Next, strategies should be employed to correct preoperative anaemia and to stabilise macrocirculation and microcirculation to optimise the patient's tolerance to bleeding. Finally, targeted interventions should be used to reduce intraoperative and postoperative bleeding, and so prevent subsequent morbidity and mortality. The objective of these updated guidelines is to provide healthcare professionals with an overview of the most recent evidence to help ensure improved clinical management of patients. For this update, electronic databases were searched without language restrictions from 2011 or 2012 (depending on the search) until 2015. These searches produced 18 334 articles. All articles were assessed and the existing 2013 guidelines were revised to take account of new evidence. This update includes revisions to existing recommendations with respect to the wording, or changes in the grade of recommendation, and also the addition of new recommendations. The final draft guideline was posted on the European Society of Anaesthesiology website for four weeks for review. All comments were collated and the guidelines were amended as appropriate. This publication reflects the output of this work.

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“…The ENRICHD clinical trial and two following clinical outcome studies reported that concurrent SSRIs was associated with a significant reduced risk of death or recurrent MI as well as an increased risk in bleeding in clopidogrel treated patients [174–176]. However, conflicting results were reported from several other studies [169, 177, 178], suggesting the necessity of further evaluation of the potential impact of SSRIs on clopidogrel antiplatelet treatment.…”

Section: Covariates That Affect Clopidogrel Dose/pk/pdmentioning

confidence: 99%

Clinical Pharmacokinetics and Pharmacodynamics of Clopidogrel

et al. 2015

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Acute coronary syndromes (ACS) remain life-threatening disorders that are associated with high morbidity and mortality. Dual-antiplatelet therapy with aspirin and clopidogrel has shown to reduce cardiovascular events in patients with ACS. However, there is substantial inter-individual variability in response to clopidogrel treatment in addition to prolonged recovery of platelet reactivity as a result of irreversible binding to P2Y12 receptors. This high inter-individual variability in treatment response has primarily been associated with genetic polymorphisms in the genes encoding for cytochrome (CYP) 2C19 that affect clopidogrel’s pharmacokinetics. While FDA has issued a boxed warning for CYP2C19 poor metabolizers due to a potentially reduced efficacy in these patients, results from multivariate analyses suggest that additional factors, including age, sex, obesity, concurrent diseases and drug-drug interactions, may all contribute to the overall between-subject variability in treatment response. However, the extent to which each of these factors contributes to the overall variability and how they are interrelated is currently unclear. The objective of this review article is to provide a comprehensive update on the different factors that influence clopidogrel’s pharmacokinetics and pharmacodynamics and how they mechanistically contribute to inter-individual differences in response to clopidogrel treatment.

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Bleeding adverse drug reactions (ADRs) in patients exposed to antiplatelet plus serotonin reuptake inhibitor drugs: analysis of the French Spontaneous Reporting Database for a controversial ADR

Abstract: The data did not demonstrate any significant association between bleeding ADRs and exposure to SRI + antiplatelet agents versus antiplatelets alone. Considering other conflicting results, this risk should be kept in mind by physicians when treating patients with several risk factors.

Cited by 12 publications

References 24 publications

Influence of pre‐operative use of serotonergic antidepressants (SADs) on the risk of bleeding in patients undergoing different surgical interventions: a meta‐analysis

Influence of pre‐operative use of serotonergic antidepressants (SADs) on the risk of bleeding in patients undergoing different surgical interventions: a meta‐analysis

Management of severe perioperative bleeding

Clinical Pharmacokinetics and Pharmacodynamics of Clopidogrel

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