Digestive Disorders Health Center

Propulsid Effective in Treating Constipated Children

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Another concern about Propulsid's use is the Jan. 24 warning statement from the FDA that the drug can be fatal in people at risk of irregular heartbeats. "We can't say too much about ... [its use] in children because our safety and efficacy database is from adult usage," Florence Houn, MD, MPH, director of the FDA's Office of Drug Evaluation III, tells WebMD. "But the FDA does encourage pediatric studies because there might be a different adverse event profile for children." Until further pediatric studies are done, Houn recommends careful prescribing of Propulsid.

"This will be a valuable addition to the tools we use to control childhood constipation," Meyers says. "One reassuring thing is that cisapride is already used to treat gastroesophageal reflux in small children, and is thought of as a fairly safe drug, so it does have a track record of safety in small children when used for short periods of time."