As mentioned in a previous post, to get cisapride for a patient in Canada, you have to contact Health Canada for special permission through the Special Access Program. The last time that I am aware of someone asking Health Canada for special access for cisapride for treatment of reflux in a preterm infant they were refused; this might sound like a good thing, but unfortunately the reason for refusal was that they hadn’t tried domperidone! I almost collapsed when I heard that one!
So is domperidone effective for GER in newborn infants? Is it safe?
You can probably guess the answers by now. No and No.
Domperidone is a drug closely related to metoclopramide, in the sense that it is a dopamine D2 antagonist, however it also has some cisapride like effects, in that it prolongs ventricular repolarization by interfering with a potassium channel. Are there any controlled studies examining domperidone effects on GER in the preterm? I found just one (Cresi F, Marinaccio C, Russo MC, Miniero R, Silvestro L: Short-term effect of domperidone on gastroesophageal reflux in newborns assessed by combined intraluminal impedance and ph monitoring. J Perinatol 2008, 28(11):766-770). A small trial that actually had controls! and randomization! And just like one of the metoclopramide studies, there was an increase in reflux in the domperidone group. This study has nice methodology with multiple intraluminal impedance combined with pH for quantifying the reflux. Domperidone does seem to be an effective prokinetic in the preterm, which may be why it increases GER.
So domperidone is ineffective for GER, indeed it is the opposite of effective, it is anti-effective! It also can prolong the QT interval, so it may be unsafe from a cardiac standpoint, and it can cause extrapyramidal side effects so probably not safe for the brain either.
Domperidone should never be used for reflux in the newborn, and probably not for other indications either. Studies of domperidone use in mothers should evaluate possible neonatal absorption and neonatal effects.
It’s funny though, this is what is recommended by our gastroenterologists; there is so much inconsistency in the treatment of GER.
That is often true, and that is why we need to be vigilant and as evidence-based as possible. When the only evidence is negative, and the drug is toxic we should protect the babies and refuse to prescribe the stuff.