Hyoscine hydrobromide patches (Scopoderm 1.5mg Patch or Scopoderm TTS Patch): risk of anticholinergic side effects, including hyperthermia

There have been a small number of reports of serious and life-threatening anticholinergic side effects associated with hyoscine hydrobromide patches, particularly when used outside the licence. Healthcare professionals, patients, parents and carers should be aware of the signs and symptoms of serious side effects and the need to seek medical help if they occur.

From:
Medicines and Healthcare products Regulatory Agency
Published
24 July 2023
Therapeutic area:
Cancer, Dispensing GP practices, Neurology, Paediatrics and neonatology

Advice for healthcare professionals:

  • be alert to the potential for anticholinergic side effects in patients who are prescribed hyoscine hydrobromide patches, particularly if used outside the licence
  • usage outside the licence includes: use for indications other than motion or travel sickness, use in children younger than 10 years of age, cutting patches, application of more than one patch at a time, continuous use of patches without a break, and long-term use
  • children and elderly patients are more susceptible to anticholinergic toxicity
  • serious anticholinergic side effects can include hyperthermia, urinary retention, delirium, hallucinations, seizures, coma, and respiratory paralysis
  • if used in hospital or residential care settings, monitor patients for signs and symptoms of anticholinergic side effects and manage these promptly if they occur
  • if used at home, counsel patients, parents and carers on side effects to be aware of and what to do if they occur
  • report suspected adverse drug reactions associated with hyoscine hydrobromide to the Yellow Card scheme

Advice for healthcare professionals to provide to patients, parents and carers:

  • hyoscine hydrobromide patches are used commonly without any problems
  • all medicines can cause unwanted side effects, and while not everybody gets them, some side effects can be serious and even life-threatening
  • it is important to be aware of the signs and symptoms of serious side effects that could be associated with hyoscine hydrobromide patches – these include high temperature, inability to urinate, confusion, disorientation, seeing or hearing things that are not there, fits or convulsions, reduced consciousness, and breathing difficulties
  • if these symptoms occur seek medical help and remove the patch immediately
  • if there is a high temperature, take immediate action to reduce body heat in addition to seeking medical help and removing the patch

Use of hyoscine hydrobromide patches

The licensed indication of a hyoscine hydrobromide patch (Scopoderm 1.5 mg Patch or Scopoderm TTS Patch) is for the prevention of motion or travel sickness symptoms (for example nausea, vomiting and vertigo) in adults and children aged 10 years of age or older. Each patch should be used for 72 hours.

There is widespread use of hyoscine hydrobromide patches outside the licence. Usage outside the licence includes:

  • indications other than motion or travel sickness
  • use in children younger than 10 years of age
  • cutting patches (this may adversely affect the bioavailability of the drug)
  • application of more than one patch at a time
  • continuous use without a break
  • long-term use

Hyoscine hydrobromide patches are often recommended in clinical guidance for indications other than motion or travel sickness. These indications (which are outside the licence) include:

  • the management of hypersecretion or hypersalivation in diverse clinical populations; for example, in patients with complex multiple disabilities or cerebral palsy, patients on ventilation, patients with Parkinson’s disease, patients requiring palliative care, and patients with drug-induced hypersalivation
  • the management of nausea and vomiting; for example, in patients after surgery or in patients with cancer

Reports of serious or life-threatening anticholinergic side effects

Hyoscine hydrobromide is a muscarinic acetylcholine receptor antagonist. Since it crosses the blood–brain barrier it has both central and peripheral actions, causing a range of anticholinergic side-effects including hyperthermia, urinary retention, dry mouth, disturbances of visual accommodation (blurred vision), mydriasis, skin irritation, generalised rash, somnolence, dizziness, memory impairment, disturbances in attention, restlessness, disorientation, confusion, hallucinations, delirium, seizures, coma, and respiratory paralysis.

After removal of the patch, hyoscine in the skin continues to enter the blood stream. Side effects may therefore persist for up to 24 hours or longer after patch removal. Children and elderly people are more susceptible to anticholinergic toxicity. Other specific risk factors for developing side effects have not been identified and there is no robust data available to give an estimate of frequency.

Hyoscine hydrobromide patches are used widely, however there have been a small number of serious and life-threatening anticholinergic side effects reported, particularly in use outside the licence. This includes the unexpected death of a child from hyperthermia caused by the hyoscine hydrobromide patch.

Following advice from the Paediatric Medicines Expert Advisory Group (PMEAG) of the Commission on Human Medicines, we have requested that Marketing Authorisation Holders (MAHs) for hyoscine hydrobromide patches add hyperthermia to both the list of side effects in section 4.8 (undesirable effects) of the Summary of Product Characteristic (SmPC) and to the Patient Information Leaflet (PIL). This is consistent with current warnings in the tablet formulation. We have also requested that the MAHs include information in the PIL regarding actions to take if hyperthermia occurs. This is consistent with information in Section 4.9 (overdose) of the SmPC.

The PMEAG also noted that underreporting of anticholinergic side effects is likely and encouraged the reporting of adverse reactions through the Yellow Card scheme.

Reporting suspected adverse drug reactions

Please report any suspected adverse drug reactions (ADRs) to hyoscine hydrobromide patches via the Yellow Card scheme. Your report will help us safeguard public health.

Healthcare professionals, patients, and carers are asked to submit reports using the Yellow Card scheme electronically using:

When reporting suspected adverse drug reactions please provide as much information as possible, including information about medical history, any concomitant medication, onset timing, and treatment dates. Please also provide the brand name (or product licence number and manufacturer), and the specific batch number.

Article citation: Drug Safety Update volume 16, issue 12: July 2023: 1.

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Published 24 July 2023
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