Reflux Medication Found Safe in Infants Studied
"Last year, I wrote 600 prescriptions for cisapride, and we never saw a problem with one of them," says Vikram Khoshoo, MD, PhD, a pediatric gastroenterologist at West Jefferson Medical Center and an associate professor of pediatrics at Tulane University in New Orleans. Khoshoo estimates that he sees more than 10,000 patients a year. "We wanted to document this experience, and we found there was not much data that was published in children," he says. Khoshoo adds that he has no financial stake in cisapride or any relationship with its manufacturer.
In his own practice, Khoshoo attributes the lack of adverse events to careful prescribing and patient education. "We calculate the dosage by weight, and we demonstrate to the mother what the dosage is in the syringe. We dispense the syringe ourselves and give them three, [with the dose] marked with a permanent marker," he says. "We send the mom home with a list of all the drugs that might have an interaction. Right off the bat, from when the medication came out, that's what we've been doing in our practice."
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.