DRUG REGULATORS have advised caution in the use of one of the Republic’s most widely used anti-nausea agents after the emergence of a possible link with sudden cardiac death. The warning is especially targeted at people aged over 60.
Domperidone, which is marketed here as Motilium and Domerid, is a long-established drug that is used to treat nausea and vomiting.
As well as having antiemetic properties, domperidone helps to propel food along the gut and is a proven treatment for upper abdominal discomfort and fullness.
Available over the counter as well as on prescription, the drug is especially popular at this time of year as an antidote to seasonal overeating.
In its latest drug safety bulletin, the Irish Medicines Board (IMB) warns doctors that two recent studies “have shown that domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death”.
Ventricular arrhythmias cause the normal pumping rhythm of the large chambers in the heart to be disrupted.
The drug, which is also licensed for use in children, is usually prescribed at a dose of 10mg three times a day for a limited period in adults.
The board’s warning, which is based on work that has been carried out by the European Medicines Agency, says caution is needed in doses of greater than 30mg a day.
The risk of unwanted cardiac effects is also thought to be higher in the over-60s.
“Healthcare professionals should be aware of these risks, closely adhere to the recommendations for use and be particularly cautious when advising or treating patients who have existing prolongation of cardiac conduction intervals . . . and those with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure,” the board says.
It has been previously established that domperidone should not be prescribed in combination with the antifungal agent, ketoconazole, or the antibiotic, erythromycin, as either combination can affect the normal heart rhythm, causing it to become dangerously prolonged.
Product information in tablet packs have been updated to include the new warnings, however it is not known whether the board will take further action to restrict the availability of domperidone as an over-the-counter medication in order to minimise the risk of older people self-medicating with doses that are higher than 30mg a day.