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

Dominik Stämpfli*, Rebecca Dommrich, Sharon Orbach-Zinger, Andrea M. Burden, Michael Heesen

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
Pages (from-to)922-928
Number of pages7
JournalInternational Journal of Clinical Pharmacy
Volume45
Issue number4
DOIs
StatePublished - Aug 2023

Funding

FundersFunder number
World Health Organization
Uppsala Monitoring Centre
ETH Zürich Foundation

    Keywords

    • Carbetocin
    • Hemodynamics
    • Obstetrics
    • Oxytocin
    • Pharmacovigilance

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