Dexilant Now Approved to Treat Teens With GERD

Published on July 15, 2016 by Sandy Liebhard

U.S. health regulators have expanded the approved uses of Dexilant to include teenagers (ages 12 to 17) who suffer from gastroesophageal reflux disease (GERD). According to a press release issued by Takeda Pharmaceuticals, North America, Inc., use of the proton pump inhibitor for this indication is supported by data drawn from studies of Dexilant capsules in adults and pharmacokinetic data involving pediatric patients ages 12 to 17.

The U.S. Food & Drug Administration (FDA) initially approved Dexilant seven years ago for the treatment of heartburn associated with symptomatic non-erosive GERD and the maintenance of healed EE and relief of heartburn. Dexilant capsules are also approved for the healing of all grades of erosive esophagitis. The expanded approval applies to Dexilant delayed-release capsules and Dexilant SoluTab delayed-release orally-disintegrating tablets.

GERD affects about 20 percent of the U.S. population and is often characterized by frequent and persistent heartburn two or more days a week despite treatment and dietary changes.

Proton Pump Inhibitor Side Effects

In addition to Dexilant, proton pump inhibitors include prescription medications like Nexium, Prilosec and PrevAcid. A number of over-the-counter versions, such as Nexium 24 HR, are also available. It is estimated that 15 million Americans used a proton pump inhibitor in 2013. However, some research suggests that 70% of this use may be inappropriate. There is a particular concern that many people are using the medications for longer periods of time than what is currently recommended.

Long-term use of proton pump inhibitors may be associated with a number of serious side effects, including an increased risk for C. diff infections, low magnesium levels, certain bone fractures, and B12 deficiency. Recent studies have also suggested that extended use of the drugs might be associated with a higher risk of renal failure and chronic kidney disease.

In 2009, the consumer advocacy group Public Citizen placed Dexilant on its “Worst Pills” list, noting that it offered no additional advantages to patients than any of the proton pump inhibitors already on the market.

“Any advantage is for the industry because the manufacturer of Dexilant charges three times more for this drug than the cost of generic lansoprazole (the generic version of PrevAcid), sold by another company and just as effective for patients,” the group said.

Proton Pump Inhibitor Lawsuits

A growing number of Nexium lawsuits have been filed on behalf of patients who allegedly suffered kidney complications due to their use of that medication. Individuals who experienced similar complications that could be related to a Dexilant or another proton pump inhibitor may be entitled to file a claim of their own.