GERD Drug Approved for Younger Children
THURSDAY, Feb. 28 -- Nexium, a popular drug to treat gastroesophageal reflux disease (GERD) in adults, has been approved for the same short-term use in children ages 1 to 11, the U.S. Food and Drug Administration said Thursday.
Two forms of Nexium (esomeprazole magnesium) were approved for younger children -- a delayed-release capsule and a liquid form. Doses approved for this age group are half of those approved for older children, the agency said. The drug was previously approved for children ages 12 to 17.
Nexium is among a class of drugs called proton pump inhibitors, which limit production of stomach acid and help heal erosion of the lining of the esophagus.
Common side effects among younger children who used Nexium were headache, diarrhea, abdominal pain, nausea, gas, constipation, dry mouth, and fatigue. The drug's safety and effectiveness haven't been evaluated in children younger than 1 year old, the FDA said.
Nexium is manufactured by AstraZeneca.
Posted: February 2008