On April 25, 2014, the European Medicines Agency completed a safety review of the drug domperidone and recommended new restrictions on its use.
Some of the main points that may be relevant to mothers taking domperidone to increase milk supply are:
• The safety concerns are about oral doses of domperidone, not the IV-only issues that were raised previously.
• The side effects that prompted the review are serious cardiac reactions to the drug, including QTc prolongation, torsade de pointes, serious ventricular arrhythmia, and sudden cardiac death.
• The risk is small, but higher when
- the total oral dose is more than 30mg per day
- domperidone is combined with other QT-prolonging medicines, which include many antibiotics and antidepressants
- domperidone is combined with CYP3A4 inhibitors, including many antibiotics, antifungals, and grapefruit juice
• The new maximum recommended oral dose is 30mg per day for no more than one week.
• Higher doses may be safe in healthy people with no drug interactions, but more research needs to be done to determine what dosages are safe.
Full press release from the European Medicines Agency