FDA Approves GERD Drug for Use in Pediatric Patients

Dexilant was approved for use in 12- to 17-year-olds with gastroesophageal reflux disease.

The FDA recently approved Dexilant (dexlansoprazole) delayed-release capsules and Dexilant SoluTab for patients 12 to 17 years old with gastroesophageal reflux disease (GERD).

Dexilant is a proton pump inhibitor (PPI) that was originally approved by the FDA in 2009 for adults. Dexilant delayed-release capsules and Dexilant SoluTab have been approved for healing erosive esophagitis for up to 8 weeks.

They both have been indicated to maintain healing for 16 weeks in patients 12- to 17-years-old, according to a press release from the FDA. Both are also indicated to treat heartburn from symptomatic non-erosive GERD for 4 weeks.

The most common adverse effects reported were headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain.

“Takeda is pleased with the FDA’s approval to expand the access of Dexilant to younger patients with GERD,” explained Thomas Gibbs, senior vice president of General Medicines at Takeda. “This new approval provides an alternative treatment option for appropriate patients with this condition. With our more than 20 years of experience in gastroenterology, we remain dedicated to all patients living with these conditions.”