These restrictions include using these agents "only to relieve symptoms of nausea and vomiting, restricting the dose and adjusting doses carefully by weight where it is licensed in children," the PRAC said in a statement released March 7.
Reducing the recommended dose and duration of treatment is "key to minimizing its risks," the Committee said. They noted that the benefits of domperidone still appear to outweigh risks when given short-term and in low doses to treat nausea and vomiting.
Domperidone-containing drugs are authorized in the EU for treatment of nausea and vomiting of various causes, including in children in some member states, and also for the management of symptoms of bloating, discomfort, and heartburn. The US Food and Drug Administration (FDA) has not approved domperidone for any indication.
In 2011, the EMA's former Pharmacovigilance Working Party recommended that the product information for domperidone-containing drugs be updated to reflect the risk for serious adverse effects on the heart, including QT prolongation and arrhythmias, and to warn that domperidone should be used with caution in patients with certain heart conditions.
However, cases of cardiac events in patients using domperidone continued to be reported, which led the PRAC to reassess whether the benefits still outweigh the risks, as reported by Medcape Medical News last year.
Today, the PRAC recommended that domperidone-containing medicines remain available and that they continue to be used for the management of the symptoms of nausea and vomiting, but that the recommended dose be reduced to 10 mg up to 3 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 3 times daily,” the PRAC advised.
"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," the committee said.
The panel also advised that "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supplying a dose of 20 mg by mouth, and suppositories of 10 or 60 mg are no longer recommended for use and should be withdrawn, as should combination products with cinnarizine (an antihistamine) where available."
The medication should also no longer be used for bloating or heartburn or for patients with moderate or severe impairment of liver function.
The PRAC's recommendations will now be sent to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a final position.