Advice for healthcare professionals:
- special caution is required when using haloperidol for the acute treatment of delirium in frail, elderly patients
- only consider haloperidol for delirium when non-pharmacological interventions are ineffective and no contraindications are present (including Parkinson’s disease and dementia with Lewy bodies)
- before initiating treatment, a baseline electrocardiogram (ECG) and correction of any electrolyte disturbances is recommended; cardiac and electrolyte monitoring should be repeated during treatment (see below)
- prescribe the lowest possible dose for the shortest possible time, ensuring that any dose up-titration is gradual and reviewed frequently
- monitor for and investigate early any extrapyramidal adverse effects, such as acute dystonia, parkinsonism, tardive dyskinesia, akathisia, hypersalivation, and dysphagia
- report suspected adverse reactions associated with haloperidol on a Yellow Card
Dosing recommendations in elderly patients
- elderly patients may have a lower clearance and longer elimination half-life of haloperidol. Dose adjustment is therefore recommended for patients with hepatic or renal impairment, as well as patients who are elderly. Prescribers should refer to local and national prescribing guidelines, as well as the dosing principles in the SmPC
- first dosing should always be very cautious, especially in elderly people, and the minimum effective dose should be prescribed for the shortest possible time. Any dose up-titration should be gradual and reviewed frequently. Regular reviews should be conducted, with the aim of discontinuing haloperidol treatment as soon as is feasible.
Neurological and cardiac side effects of haloperidol
- since 1964 and up to 4 September 2021, the MHRA had received a total of 1341 Yellow Card reports containing 3385 suspected adverse drug reactions relating to haloperidol. Of these, 242 reports related to patients from 60 years of age or older and the majority of the reactions (171) related to adverse effects in the nervous system
- extrapyramidal side effects may include acute dystonias, parkinsonism, or tardive dyskinesia, each of which may impair a patient’s ability to swallow, a complication of which can be inhalation of throat or stomach contents and eventually aspiration pneumonia. Healthcare professionals are encouraged to undertake early monitoring and investigation of drug-induced dysphagia in elderly patients
- haloperidol is also associated with QTc prolongation and ventricular arrhythmias
- use of haloperidol is contraindicated in patients with known QTc prolongation, congenital long QTc syndrome and in patients taking other drugs known to prolong the QTc interval – examples are provided in the Interactions section of the SmPC
- a baseline ECG is recommended before treatment, particularly in patients with cardiovascular risk factors or a history of cardiovascular disease
- need for further ECGs during treatment should be assessed on an individual basis, and blood pressure monitoring during treatment is also advised
- dose-related orthostatic hypotension is known to occur in elderly people treated with haloperidol, which may increase the risk of falls
- other adverse reactions listed in the product information include rhabdomyolysis and rare cases of neuroleptic malignant syndrome, for which prompt medical intervention is required.
Reference:
- MHRA. Haloperidol (Haldol): reminder of risks when used in elderly patients for the acute treatment of delirium Drug Safety Update volume 15, issue 5: December 2021: 1.