FDA says "Yes" to Nexium for short-term tx of GERD in12-to-17-year-olds

May 17, 2006

AstraZeneca announced earlier this month that the FDA hasapproved the use of esomeprazole magnesium (sold as Nexium)delayed-release capsules for short-term treatment ofgastroesophageal reflux disease (GERD) in children 12 to 17 yearsof age.

AstraZeneca announced earlier this month that the FDA has approved the use of esomeprazole magnesium (sold as Nexium) delayed-release capsules for short-term treatment of gastroesophageal reflux disease (GERD) in children 12 to 17 years of age.

The safety of Nexium in adolescents in this age group was evaluated in a multicenter, randomized, double-blind parallel group study in which 149 subjects with clinically diagnosed GERD were treated with either Nexium, 20 mg, or Nexium, 40 mg, once daily for as long as eight weeks. (The use of Nexium in children 12 to 17 years old is supported by results from studies in adults and additional safety and pharmacokinetics studies in adolescents 12 to 17 years of age.)

The most frequently reported treatment-related adverse events were headache, abdominal pain, diarrhea, and nausea. No safety concerns were identified.

GERD is believed to affect approximately 8% of children in the United States between 12 and 17 years old-about three million children. In children, GERD manifests mostly as vomiting or regurgitation (at times, persistent), as well as diminished appetite or refusal to eat. Other conditions, such as asthma, may also be a sign of the disease. First-line treatment is lifestyle modification—such as smaller, more frequent meals and dietary changes. If these methods prove inadequate, over-the-counter antacids and certain prescription medications that suppress acid may be beneficial.