Domperidone –change in licensed age groups and weight ranges
Domperidone preparations no longer licensed in children under 12 years of age and those weighing under 35kg
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug safety update which states that, domperidone is no longer licensed to treat nausea and vomiting in children under 12 years and those who weigh less than 35kg due to its lack of efficacy in these patient groups. Domperidone is now only licensed in adults and children aged over 12 years and who weigh 35kg or more.
Pharmacists should read the MHRA drug safety update which covers this and other important patient safety aspects of domperidone; these include:
- Reminder of contraindications; for example use in patients who:
- Have liver impairment
- Underlying heart disease and known pre-existing QT interval prolongation
- Reminder of recommendations on maximum daily dose and duration of treatment – use at the lowest effective dose for the shortest length of time possible
- Further information on lack of domperidone efficacy in children aged under 12 years
For further information on this or any other query, please contact the NPA Pharmacy Services team on 01727 891 800 or email firstname.lastname@example.org.
Produced by the NPA Pharmacy Services team December 2019