Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment
2016-1012
2017-12-18
FDA-2017-D-5912-0003
05:00:00
https://api.regulations.gov/v4/comments/FDA-2017-D-5912-0003
Anonymous
Anonymous
Gastroesophageal reflux (GERD) occurs in infants, children and adults. According to a large community-based study of children in the United States, the prevalence of various symptoms suggestive of gastroesophageal reflux was 1.8 to 8.2 percent (Winter, 2016). The presence of GERD in children is on the rise, possibly due to the increase in childhood obesity. Higher rates of GERD can be seen among children with developmental and neuromuscular disorders. Children need an adequate treatment plan for GERD. Although, developing drug treatment in the pediatric population can be complicated it is necessary. As for excluding infants in a clinical trial, it is a disservice to the infant population. The diagnosis of GERD in infants can be complicated due to other possible diagnoses. Regurgitation is present in 50 to 70 percent of all infants which peaks at age four to six months, and typically resolves by one year (Winter, 2016). Infants can develop other symptoms related to untreated GERD. A small minority of infants with GERD develop other symptoms suggestive of GERD, including irritability, feeding refusal, hematemesis, anemia, respiratory symptoms, and failure to thrive (Winter, 2016). It is necessary to evaluate drug treatment for GERD in the infant population. ReferencesWinter (2016). Clinical manifestations and diagnosis of gastroesophageal reflux disease in children and adolescents. UpToDate. Winter (2017). Gastroesophageal reflux in infants. UpToDate.