MHRA reminds healthcare professionals and patients of significant for consideration of recommendation for the safe and effective usage of haloperidol for delirium for elderly patients

What needs consider before using haloperidol in a elderly patient for delirium?

Second-line treatment: when the first-line non-drug treatments found ineffective, then onlu consider haloperidol for use by adhering to a patient-centric benefit-risk estimate strategy based on individual elder patient condition(s), like below:

Restricted use: Haloperidol is contraindicated in patient Parkinson’s disease and dementia with Lewy bodies due to unfavorable benefit-risk profile in the context of underlying disease condition.

Low-dose and short-term use: if patients are not having contraindicated disease conditions & shown ineffective response with first-line treatment, consider using haloperidol with lowest dose and shortest time possible with continuous monitoring of expected safety reactions.

Caution/monitoring for extrapyramidal side effects: Take special care for monitoring and early identification of any extrapyramidal adverse effects –

  1. Acute Dystonia,
  2. Parkinsonism,
  3. Tardive Dyskinesia,
  4. Akathisia,
  5. Hypersalivation
  6. Dysphagia

Consider early actions (treatment interruptions/discontinuation of haloperidol upon identification serious side effects.

Voluntary ADR reporting:

Every medicinal product has both benefits and risks. Medicines are authorized to market based on the favorable benefit-risk profile anticipated at the time of regulatory approval/entry into market. However, the safety profile of medicine would continuously updates owing to safety data from the post marketing experience from public. If the rate of reporting of suspected adverse drug reactions (ADR) from public is line with the actual occurrence of ADRs, the time lapse for taking regulatory action can be reduced and thereby improving patient safety.

All health care professionals and consumers of pharmaceutical medicinal products are encouraged to be aware of this fact and observe/monitor for any possible adverse events, reactions, medication errors, or quality complaints of medicinal products and report the same to your respective national health authority.

This would accumulate safety evidence for medicinal products which in turn help health authorities to take regulatory actions at the earliest possibility for a better patient safety and overall public health.

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