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Domperidone use restricted following cardiac safety concerns

GPs have been advised they should no longer prescribe patients domperidone for dyspepsia or gastro-oesophageal reflux disease, after the European regulator ruled the drug’s potential to cause cardiac side effects outweighs its benefits in these indications.

The drug – brand name Motilium – should now be used only for relief of nausea and vomiting, for which it should be prescribed at the lowest possible dose and usually for no longer than one week, the European Medicines Agency said.

In addition, the maximum daily dosages of domperidone have been reduced to 30 mg (10 mg three times a day) for adults and adolescents over 12 and weighing 35 kg or more, while for children under 35 kg the recommended maximum daily dose is now 0.75 mg/kg body weight.

The restrictions - also announced by the UK’s Medicines and Healthcare Products Regulator Agency - come after a Europe-wide review found domperidone was associated with an increased risk of serious adverse cardiac drug reactions including prolonged QT interval, arrhythmias and sudden cardiac death.

The drug, which is also available from pharmacies without a prescription, should not be used at all in people with cardiac problems or severe hepatic impairment, or in conjunction with other medications known to prolong QT or with potent inhibitors of the CYP3A4 enzyme, including certain antibiotics such as clarithromycin and erithromycin.

Readers' comments (3)

  • Vinci Ho

    This problem of prolonged QT interval seems to have caused several limitations in several commonly prescribed drugs: high dose Citalopram, Venlafaxine(warning dropped ), some atypical antipsychotics ,etc. I suppose many centrally acting drugs have this risk somehow? I still remembered fitting patients with cardiac monitors when they were on IV phenytoin in hospital.....

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  • Just remind me who is going to fund searching for these people, writing to them and trying to find a non-exist alternative.........?

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  • Come on silly-billy. You have a computer system and staff. You also have a responsibility to those patients to whom you have prescribed Domperidone. Especially if on repeat prescribing. Stop whining and get on with it.

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