Dataset Information

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

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.

SUBMITTER: Stampfli D

PROVIDER: S-EPMC10366022 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

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

Stämpfli Dominik D Dommrich Rebecca R Orbach-Zinger Sharon S Burden Andrea M AM Heesen Michael M

International journal of clinical pharmacy 20230510 4

<h4>Background</h4>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.<h4>Aim</h4>The aim of this work was to exploratively examine reports of adverse drug events of both drugs and to establish a comparative haemodynamic profile.<h4>Method</h4>Using data extracted from the Wor ...[more]

PMID: 37162656

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Dataset Information

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

Background

Aim

Method

Results

Conclusion

Publications

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

Similar Datasets

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