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Reflux Medication Found Safe in Infants Studied

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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may go the way of Seldane (terfenadine)," Fenrich says, referring to the popular allergy medicine that was ultimately withdrawn because of its risk of possible ill effects.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.

Vital Information:

  • Propulsid is a drug used to treat reflux, a condition that causes babies to spit up frequently.
  • The drug is currently under review by the FDA for heart rhythm irregularities in adults taking the drug, but a new study shows that it does not cause these problems in infants.
  • Careful prescribing and patient education are key factors in administering the drug safely to babies.

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