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Neuroleptics & Cardiac Side Effects
Notice type:
3rd Party Publications
Date:
31/05/2007
Product name or type:
Neuroleptics
Reference:
MIMS Publication May 2007
Target Audience:
Healthcare Professionals
Problem Or Issue:
Neuroleptics are a class of medicinal products authorised in Ireland for the treatment of acute and chronic schizophrenia and other psychotic conditions, as well as for the management of manic disorders, bipolar disorder, severe agitation and disturbed behaviours in patients with schizophrenia.
Following concerns regarding the cardiotoxicity of thioridizine in 2000, and its subsequent withdrawal from the market, a review of all neuroleptic medicinal substances was initiated at a European level to consider the level of cardiac risk associated with each neuroleptic substance and to consider the possibility of an overall class effect.
This review was recently completed and concluded that products containing
haloperidol, pimozide, sertindole or ziprasidone
should be absolutely contra-indicated in the following circumstances:
Clinically significant cardiac disorders (e.g. recent acute myocardial infarction, uncompensated heart failure, arrhythmias treated with class IA and III antiarrhythmic medicinal products), QTc interval prolongation, History of ventricular arrhythmia or Torsades de pointes, Uncorrected hypokalaemia, and Patients taking other QT prolonging drugs. These substances should be used with caution in patients with cardiovascular disease or a family history of QT prolongation.
In addition, it is recommended that patients undergo a baseline ECG prior to commencement of treatment and that the need for on-going ECG monitoring is assessed on an individual patient basis. Whilst on therapy, the dose of these neuroleptics should be reduced if the QT is prolonged and should be discontinued if QTc is > 500ms. Finally, periodic electrolyte monitoring is recommended during therapy and the concomitant use of other neuroleptic medicines should be avoided. The remaining substances that fall into the neuroleptic class of medicines were considered to have either insufficient data (loxapine, oxypertine, perphenazine, pipothiazine, prochlorperazine, promazine and remoxipride) or limited data from at least one source (amisulpride, benperidol, chlorpromazine, clozapine, fluphenazine, flupenthixol, levomepromazine, olanzepine, quetiapine, risperidone, sulpiride, trifluoperazine, zotepine and zuclopenthixol) to suggest a potential cardiac risk/risk of QT prolongation. For these substances, caution is recommended in patients with cardiovascular disease or a family history of QT prolongation and the concomitant use of other neuroleptic medicines should be avoided.
The IMB is currently working with companies marketing neuroleptic medicines in Ireland to ensure that the product information is appropriately updated to reflect this important safety information. Healthcare professionals are reminded that suspected adverse reactions, including those associated with use of neuroleptic medicines, should be reported to the IMB in the usual way.
Background Information Or Related Documents:
Neuroleptics Cardiac Side Effects Document
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Date Printed: 26/04/2024