The Food and Drug Administration has approved use of the drug Nexium in children aged 1 to 11 who have acid reflux disease.
FDA said Thursday it approved liquid and delayed-release capsules of Nexium in doses of 10 milligrams or 20 milligrams for these youngsters. It is already approved in doses of 20 milligrams or 40 milligrams for those aged 12 to 17.
Nexium, manufactured by AstraZeneca of Wilmington, Del., is a type of drug known as a proton pump inhibitor, which reduces the amount of acid produced in the stomach and helps heal damage to the esophagus caused by excess acid.
The approval was for short-term use in these children, FDA said. The most common side effects in children were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth and sleepiness, the agency said.