Safety alert about rare but serious side-effects with hyoscine patches

Hyoscine patches are commonly used to dry up airway secretions and saliva, to reduce nausea and vomiting after an operation or during cancer treatment, and for travel sickness and vertigo (dizziness).

The MHRA (Medicines and Healthcare products Regulatory Agency – the agency responsibility for the safety of medicines in the UK) has recently warned that young children may have an increased risk of some rare but serious side-effects.

The rare side-effects include:

• hyperthermia – an abnormally high body temperature with no obvious cause e.g. infection
• difficulty breathing
• being unable to urinate (do a wee)
• seeing or hearing things that are not there
• confusion

If you think your child is experiencing any of these side-effects, remove the patch and contact your doctor.

• If they have a high temperature, take immediate steps to reduce their temperature, such as by removing clothing and applying a damp towel; you can give your child paracetamol to reduce their temperature.

Most children use patches without any problems. However, it is important that you use the patches as you have been told to by your healthcare professional. In particular, make sure that each patch is removed before the next one is applied, so that your child has only one patch on at a time.

• You can read more about the safety alert on the UK Government website here.
• Parents and carers are asked to report any suspected side-effects to the UK  safety scheme at mhra.gov.uk/yellowcard.
• More information on side-effects can be found on the medicines for children website here.

Parents and carers need to be aware that some of the uses of hyoscine in children are outside of its licence. You can read more about why children and young people are sometimes prescribed ‘unlicenced medicines’ below.

Hyoscine is licensed for the treatment of travel sickness and vertigo in children aged 10 years and older. One patch is used for 72 hours.

 More about unlicenced use of medicines

• When manufacturers develop new medicines, they usually do clinical trials in adults.
• The licence (or marketing authorization) states the uses that the manufacturer can promote the medicine for, based on how it was evaluated in trials.
• Often, once a medicine has been widely used in adults and doctors know how to use it, it may also be used in children.
• Manufacturers rarely do clinical trials in children, so they cannot get a licence for use in children or promote the medicine for use in children.
• This means that use of the medicine in children is unlicensed.
• However, medicines are only used for children if this is considered safe.
• You can read more about unlicensed medicines here, or ask your medical team.