Feb 29, 2008 4:49 pm US/Eastern
FDA Approves Drug For Children With Reflux
(KDKA)
The drug Nexium helps millions of people control their heartburn, and federal health officials now say the drug can also be beneficial to children.
Experts say up to one in 20 children have a condition called reflux, and while for adults watching your diet and eating patterns can help as well as medications, for kids that can be a challenge.
Until now, only one medication called Prevacid has been approved for children diagnosed with reflux, where the stomach acid flows back and erodes the swallowing tube.
"One of the difficult things in practicing pediatrics is there are very few medications that are actually tested and approved in young children," says Dr. David Keljo, of gastroenterology at Children's Hospital.
Now the FDA has approved the reflux drug Nexium, a stomach acid reducer for short-term use in children from ages one to 11.
The FDA said they considered the drug's safety and how well it works in adults.
One pediatric study showed Nexium, in more than a hundred patients, was safe and well-tolerated and erosions in the swallowing tube healed after eight weeks of treatment.
Doctors say side effects include headache, nausea, diarrhea, stomach pain, constipation, gas, dry mouth and sleepiness.
After a drug is FDA approved, experts say there is still more study and monitoring to be done. Researchers say certain types of infections in the digestive system have been noted with Nexium and with long term use thinning bones and a vitamin deficiency.
So officials say they will have to watch if these things become more common as more people use the drug.
(© MMIX, CBS Broadcasting Inc. All Rights Reserved.)
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