Reflux Medication Found Safe in Infants Studied
While it is "good information" that few of the babies had abnormal QT intervals, the study may be too small to be significant, says William A. Engle, MD, a neonatologist and professor of pediatrics at Indiana University, who reviewed the study for WebMD. "There are only 100 babies total, so the power of the study is still pretty tiny. I think the author is correct that he has not had problems, and most of us have not seen problems." But a larger study of "thousands" of infants is probably in order to establish the true incidence of cardiac abnormalities, he says.
The controversy over cisapride "has obviously altered my practice. We were not routinely doing ECGs before giving cisapride, but many of us are leaning toward doing that, and reconsidering its use and being more selective in its use," Engle says of his 17 fellow neonatologists at Indiana University Medical Center.
To Arnold L. Fenrich, MD, the study shows that good results can be expected when the drug is used appropriately. "Their approach in limiting the dose and in ensuring the appropriate doses were given demonstrated that it can be used safely," says Fenrich, a pediatric cardiologist and assistant professor of pediatrics at Baylor College of Medicine who also reviewed the study for WebMD.
Fenrich adds that he does not support a blanket recommendation that children should receive ECGs if they are on Propulsid. "I think the drug company is saying that to protect themselves," he says, adding that careful dispensing to eliminate interactions with other medications and adherence to a low dose are probably adequate precautions in most cases. He says the drug may ultimately be replaced by something with fewer risks. "It may go the way of Seldane (terfenadine)," Fenrich says, referring to the popular allergy medicine that was ultimately withdrawn because of its risk of possible ill effects.
Without Propulsid, treatment options for reflux are limited, Khoshoo says. "If you look at the literature, there are only three interventions proven to be effective in preventing reflux in children," he says. "The first is positioning, with the head elevated and sleeping on the stomach. The second is thickening the formula with cereal. The third is cisapride. The first was shot down by the American Academy of Pediatrics because of [sudden infant death syndrome]. And people are going to shoot down number three, and I don't think they should. I think they should exercise caution. Just because the physician cannot afford the time to educate the parents, that should not mean that the child is denied an effective medication."
Before prescribing cisapride, Khoshoo asks parents to try the first two methods for two weeks. If they don't see an improvement, he will suggest cisapride. Khoshoo says he does not routinely order upper-GI and other tests before prescribing cisapride, but will do so when the infant has other problems, such as asthma, gagging, vomiting blood, or a history of apnea.