PRAC Recommends Changes for Domperidone
According to Medscape, the European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) wants changes to be made to domperidone-containing drugs because of cardiac risks, including QT prolongation and arrhythmias.
About the PRAC Decision
The PRAC released a statement March 7 indicating that the restrictions include using the 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 committee says that reducing the dose is key to minimizing the risks associated with the drug, and noted that the benefits of domperidone still outweigh the risks when given short-term and in low doses to treat nausea and vomiting.
Although the US Food and Drug Administration (FDA) has not approved domperidone for any indication, the EU authorizes the use of domperidone-containing drugs to treat nausea and vomiting in various cases, including in children in some member states, and also to manage symptoms including bloating, discomfort and heartburn.
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 in 2011; however, cases of cardiac events in patients using domperidone continued to be reported.
Current PRAC Recommendations for Domperidone
The PRAC still recommends that domperidone-containing medicines remain available, and that they continue to be used to manage 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.
The committee said measuring devices should be included with liquid formulations to allow accurate dosing by bodyweight and that the medicine should not normally be used for longer than one week.
The PRAC also advised that these patients may also be given the medicine as suppositories of 30mg twice daily and that 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 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, and that the medication should also no longer be used for bloating or heartburn or for patients with moderate or severe impairment of liver function.
These recommendations by the PRAC are being sent to the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) where they will make the final decision.