Dexilant (dexlansoprazole delayed-release capsule) and Dexilant Solutab are prescription drugs manufactured by Takeda Pharmaceutical Company Ltd. Dexilant and Dexilant Solutab are in a class of drugs known as proton pump inhibitors (PPI). Dexilant is approved for the following indications in patients 12 years of age or older:
• Healing of all grades of erosive esophagitis (EE);
• Maintenance of healed EE and relief of heartburn; and
• Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD).
Dexilant Solutab is approved for the following indications in patients 12 years of age or older:
• Maintenance of healed EE and relief of heartburn;
• Treatment of symptomatic non-erosive GERD.
Dexilant was first approved in 2009 for adults for indications of EE, maintenance of healed EE and treatment of heartburn associated with symptomatic non-erosive GERD. The adult dosages were dependent on the indication: 60 mg once daily up to eight weeks was the approved dosing for healing of EE; 30 mg once daily for up to six months was approved dosing for maintenance of healed EE; and once daily for up to four months was approved dosing for treatment of heartburn associated with symptomatic non-erosive GERD. Dexilant Solutab was first approved by the U.S. Food and Drug Administration (FDA) in 2016.
In 2015, Takeda sought approval to include children aged 12 to 17 years in the approved indications for Dexilant. In July 2016, the FDA approved Dexilant for children aged 12 to 17 years.
From 2009 through 2016, there have been 5,635 reports to the FDA concerning side effects related to Dexilant. Of those, 331 (5.87 percent) of the people reporting side effects have reported vertigo. Fifty-five percent of the people reporting vertigo involved usage of less than one month, and 20 percent involved usage between one and six months. Seventy-five percent of the people reporting vertigo are female. More than 90 percent of the people reporting vertigo are older than 40.
In the prescribing information for Dexilant, the serious adverse reactions are identified as acute interstitial nephritis, Colostridium difficile-associated diarrhea, bone fracture, cutaneous and systemic lupus erythematosus, cyanocobalamin (Vitamin B-12) deficiency and hypomagnesemia. Common adverse reactions included diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting and flatulence. Common adverse reactions are defined as those occurring > 2 percent.
The prescribing information identifies “less common adverse reactions” as those with an incident of less than 2 percent and includes dizziness under nervous system disorders. However, the prescribing information fails to provide any warnings or precautions that serious or repeated vertigo is a potential adverse reaction. Serious adverse events of hypertension have also been reported in association with twice daily doses of DEXILANT 60 mg, increasing the risk of stroke.