Tags

Type your tag names separated by a space and hit enter

Comparative safety of antipsychotics in the WHO pharmacovigilance database: the haloperidol case.
Int J Clin Pharm. 2011 Oct; 33(5):806-14.IJ

Abstract

BACKGROUND

Starting in 2007, regulatory agencies strengthened label warnings for intravenous haloperidol. Based on adverse drug reaction (ADR) reports of QT prolongation and torsades de pointes, regulatory agencies recommended the use of continuous telemetry or advising against the intravenous administration in general. Intravenous haloperidol is commonly used as a first line treatment for acute delirium. Consequently, the extended warning has caused uncertainty among health care professionals.

OBJECTIVE

The aim of this study is to critically evaluate the WHO global individual case safety report (ICSR) database VigiBase for QT prolongation, torsades and/or cardiac arrest involving intravenous haloperidol compared to other routes of administration and the antipsychotics olanzapine and quetiapine.

METHOD

All WHO safety reports (1972-2010) of cardiac reactions associated with haloperidol, quetiapine and olanzapine were evaluated, including dose, route of administration and patient risk factors. Reporting odds ratios for the 3 antipsychotics were calculated. Main outcome measure Number of submitted reports on different antipsychotics.

RESULTS

The absolute number of ICSR regarding QT prolongation, torsades and/or cardiac arrest were: haloperidol (365 cases), olanzapine (489) and quetiapine (520). Reporting rates of haloperidol did not increase over the last two decades. 32% of the haloperidol cases involved oral, 16.4% intramuscular and 22.7% intravenous administration. The difference of the reporting odds ratios of haloperidol and quetiapine were not statistically significant. Olanzapine was associated with a slightly lower reporting odds ratio.

CONCLUSION

While regulatory agencies advise against the use of intravenous haloperidol, review of VigiBase does not reveal that the intravenous route is any more likely to be associated with cardiac adverse events. Furthermore, our results do not demonstrate any additional risk associated with haloperidol when compared with alternative agents. Although pharmacovigilance data does not routinely include a denominator regarding frequency of use, regulatory agencies are currently advising against the use of intravenous haloperidol based on pharmacovigilance, but the number of overall reports is greater for quetiapine and olanzapine when compared to haloperidol. Improved pharmacovigilance approaches are needed to more accurately address the safe, effective use of medicines.

Authors+Show Affiliations

Clinical Pharmacy and Epidemiology, Department of Pharmaceutical Sciences, University of Basel, Basel, Switzerland. carla.meyer@unibas.chNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

21809143

Citation

Meyer-Massetti, Carla, et al. "Comparative Safety of Antipsychotics in the WHO Pharmacovigilance Database: the Haloperidol Case." International Journal of Clinical Pharmacy, vol. 33, no. 5, 2011, pp. 806-14.
Meyer-Massetti C, Vaerini S, Rätz Bravo AE, et al. Comparative safety of antipsychotics in the WHO pharmacovigilance database: the haloperidol case. Int J Clin Pharm. 2011;33(5):806-14.
Meyer-Massetti, C., Vaerini, S., Rätz Bravo, A. E., Meier, C. R., & Guglielmo, B. J. (2011). Comparative safety of antipsychotics in the WHO pharmacovigilance database: the haloperidol case. International Journal of Clinical Pharmacy, 33(5), 806-14. https://doi.org/10.1007/s11096-011-9541-y
Meyer-Massetti C, et al. Comparative Safety of Antipsychotics in the WHO Pharmacovigilance Database: the Haloperidol Case. Int J Clin Pharm. 2011;33(5):806-14. PubMed PMID: 21809143.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative safety of antipsychotics in the WHO pharmacovigilance database: the haloperidol case. AU - Meyer-Massetti,Carla, AU - Vaerini,Simone, AU - Rätz Bravo,Alexandra E, AU - Meier,Christoph R, AU - Guglielmo,B Joseph, Y1 - 2011/08/02/ PY - 2011/03/05/received PY - 2011/07/11/accepted PY - 2011/8/3/entrez PY - 2011/8/3/pubmed PY - 2012/9/27/medline SP - 806 EP - 14 JF - International journal of clinical pharmacy JO - Int J Clin Pharm VL - 33 IS - 5 N2 - BACKGROUND: Starting in 2007, regulatory agencies strengthened label warnings for intravenous haloperidol. Based on adverse drug reaction (ADR) reports of QT prolongation and torsades de pointes, regulatory agencies recommended the use of continuous telemetry or advising against the intravenous administration in general. Intravenous haloperidol is commonly used as a first line treatment for acute delirium. Consequently, the extended warning has caused uncertainty among health care professionals. OBJECTIVE: The aim of this study is to critically evaluate the WHO global individual case safety report (ICSR) database VigiBase for QT prolongation, torsades and/or cardiac arrest involving intravenous haloperidol compared to other routes of administration and the antipsychotics olanzapine and quetiapine. METHOD: All WHO safety reports (1972-2010) of cardiac reactions associated with haloperidol, quetiapine and olanzapine were evaluated, including dose, route of administration and patient risk factors. Reporting odds ratios for the 3 antipsychotics were calculated. Main outcome measure Number of submitted reports on different antipsychotics. RESULTS: The absolute number of ICSR regarding QT prolongation, torsades and/or cardiac arrest were: haloperidol (365 cases), olanzapine (489) and quetiapine (520). Reporting rates of haloperidol did not increase over the last two decades. 32% of the haloperidol cases involved oral, 16.4% intramuscular and 22.7% intravenous administration. The difference of the reporting odds ratios of haloperidol and quetiapine were not statistically significant. Olanzapine was associated with a slightly lower reporting odds ratio. CONCLUSION: While regulatory agencies advise against the use of intravenous haloperidol, review of VigiBase does not reveal that the intravenous route is any more likely to be associated with cardiac adverse events. Furthermore, our results do not demonstrate any additional risk associated with haloperidol when compared with alternative agents. Although pharmacovigilance data does not routinely include a denominator regarding frequency of use, regulatory agencies are currently advising against the use of intravenous haloperidol based on pharmacovigilance, but the number of overall reports is greater for quetiapine and olanzapine when compared to haloperidol. Improved pharmacovigilance approaches are needed to more accurately address the safe, effective use of medicines. SN - 2210-7711 UR - https://www.unboundmedicine.com/medline/citation/21809143/Comparative_safety_of_antipsychotics_in_the_WHO_pharmacovigilance_database:_the_haloperidol_case_ L2 - https://dx.doi.org/10.1007/s11096-011-9541-y DB - PRIME DP - Unbound Medicine ER -