PRAC recommends restricting use of domperidone
Benefits still considered to outweigh risks when given short-term and in low
doses to treat nausea or vomiting

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has
completed a review of domperidone-containing medicines and has recommended changes to their use
throughout the European Union (EU), including using these medicines only to relieve symptoms of
nausea and vomiting, restricting the dose and adjusting doses carefully by weight where it is licensed
in children.
Reducing the recommended dose and duration of treatment was considered key to
minimising its risks.

Domperidone-containing medicines have been authorised nationally in individual Member States of the
EU for the treatment of nausea and vomiting of various causes (including in children in some Member
States) but also for the management of symptoms such as bloating, discomfort and heartburn.

The review of domperidone was carried out at the request of the Belgian medicines authority over
concerns about the medicine’s effects on the heart.
The injectable form of domperidone was withdrawn
in 1985 because of such side effects.

Serious effects on the heart, including QT prolongation (an
alteration of the electrical activity of the heart) and arrhythmias (unstable heartbeats), have previously
been evaluated by the EMA’s former Pharmacovigilance Working Party (PhVWP).
In 2011, the PhVWP
recommended that the product information for domperidone-containing medicines be updated to
reflect the risk of these adverse effects and to warn that domperidone should be used with caution in
patients with certain heart conditions.
However, cases of heart problems in patients using the medicine
continued to be reported, and the PRAC was therefore asked to examine whether the benefits still
outweighed the risks for these medicines in their approved uses, and whether their marketing
authorisations should be maintained or changed across the EU.

The PRAC recommended that domperidone-containing medicines
should remain available and may
continue to be used in the EU for the management of the symptoms of nausea and vomiting, but that
the recommended dose should be reduced to 10 mg up to three times daily by mouth for adults and
adolescents weighing 35 kg or more.
These patients may also be given the medicine as suppositories
of 30 mg twice daily.

Where the medicine is licensed in children and adolescents weighing less than 35
kg, it should be given by mouth at a dose of 0.25 mg per kg bodyweight up to three times daily.

Measuring devices should be included with liquid formulations to allow accurate dosing by bodyweight.
The medicine should not normally be used for longer than one week.

Domperidone should no longer be authorised to treat other conditions such as bloating or heartburn.
It
must not be given to patients with moderate or severe impairment of liver function, or in those who
have existing abnormalities of electrical activity in the heart or heart rhythm, or who are at increased
risk of such effects

In addition, it must not be used with other medicines that have similar effects on
the heart or reduce the breakdown of domperidone in the body (thus increasing the risk of side
effects). The product information should be amended appropriately.

Products supplying a dose of
20 mg by mouth, and suppositories of 10 or 60 mg are no longer recommended for use and should be
withdrawn, as should combination products with cinnarizine (an antihistamine) where available

Domperidone works by blocking receptors for the neurotransmitter dopamine found in the gut and in
the part of the brain linked to vomiting. This helps prevent nausea (feeling sick) and vomiting.

G Mohan.