Limiting use of Domperidone – Motilium due to cardiac side effects
- Motilium is a drug primarily used to treat nausea and vomiting.
- In rare cases, Motilium (which contains the active ingredient, domperidone) may cause the development of potentially life-threatening arrhythmias (prolonging of the QT interval, Torsade de pointes).
This is a known and rare risk.
The European Medicines Agency has received reports of Motilium causing these side effects (despite existing warnings and restrictions that have been published), and it has therefore decided to add restrictions in order to reduce the risk of patients developing these side effects.
The Advisory Committee for Drug Safety at the Ministry of Health has discussed this issue and decided to adopt the new restrictions.
It is know that the risk of developing heart rhythm disorders of this kind (arrhythmias) increases after age 60, when dosages exceed 30 mg per day, and when combined with certain additional medications and risk factors.
Below is an overview of the new restrictions:
- Treatment should be prescribed for the shortest possible period. As a rule, duration of treatment should not exceed 7 days.
- The lowest effective dosage should be prescribed. The medicine dosage for tablets shall be limited to 10 mg, up to 3 times per day.
- The maximum daily dosage is 30 mg for adults and for children weighing over 35 kg.
- This medication shall be limited to treatment of nausea and vomiting only. (Until recently, Motilium was prescribed for treatment of additional digestive problems such as bloating, abdominal discomfort and heartburn. However, these indications have been revoked due to the lack of sufficient evidence of the efficacy of this treatment.)
- The medication should not be prescribed for patients who are at risk for developing arrhythmias. Careful attention should be paid to drug interactions that increase the risk of developing life-threatening arrhythmias (as explained in detail in the leaflet).
- The medication shall not be administered to patients suffering from electrolyte disorders (such as reduced blood potassium levels or reduced blood magnesium levels).