EMA restricts domperidone dose and duration of use

30th April 2014

The European Medicines Agency (EMA) has recommended changes to the indications, dose and duration of use of domperidone in adults and children following a review. This follows concerns highlighted in 2012 that domperidone is associated with a small increased risk of serious cardiac undesirable effects. Domperidone is now:

• indicated for nausea and vomiting only, all other uses are unauthorized
• contra-indicated in patients:
  • where cardiac conduction is, or could be, impaired
  • with underlying cardiac disease, e.g. CHF
  • with severe hepatic impairment
  • concurrently receiving drugs known to be CYP3A4 inhibitors and/or cause QT prolongation.

In addition domperidone:

• should be used at the lowest effective dose, for the shortest possible time (generally ≤1 week)
• should be limited to a maximum dose of 10mg t.d.s. (for adults and children >12 years and >35kg) or 0.25mg/kg t.d.s (for children <12 years and <35kg).

Patients should be advised to seek prompt medical attention should symptoms such as syncope or cardiac arrhythmias occur.

The restrictions also apply to OTC domperidone products, with a maximum duration of use of 48h.

The full EMA report and MHRA health professionals letter can be found from the links below.

EMA domperidone report

MHRA health professionals letter

Note: palliativedrugs.com has contacted the EMA for clarification surrounding the use of domperidone in palliative care.

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Free access to the on-line Palliative Care Formulary renewed for NHS Scotland

25th April 2014

We are delighted to report that NHS Education for Scotland has subscribed to the on-line Palliative Care Formulary (PCF) for a second year. The on-line PCF is hosted on the Palliative Care portal of the Knowledge Network website and is available free of charge to those with an NHS Education Scotland ATHENS user name and password. The content is continually updated and represents the most current version.

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NICE guideline on managing pressure ulcers

23rd April 2014

The UK National Institute for Health and Care Excellence (NICE) has published a clinical guideline on managing pressure ulcers (CK179).

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Dexamethasone 4mg/mL injection supply problem

11th April 2014

There is a UK manufacturer’s supply problem with the MSD (Organon livery) dexamethasone base 4mg/mL injection. It is unclear when normal supply will resume.

The alternative Hospira brand of dexamethasone injection available (dexamethasone phosphate 4mg/mL) contains dexamethasone base 3.3mg/mL. There is scope for confusion when switching to this preparation or when switching from PO to SC route.

For more details clarifying dexamethasone prescribing see the www.palliativedrugs.com factsheet below, produced in 2010 when the labeling and prescribing of dexamethasone injection was standardized to dexamethasone base by the MHRA.

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