FDA approves brand-name change for dexlansoprazole

May 5, 2010

FDA would like to alert healthcare providers to the recent proprietary name change for dexlansoprazole delayed-release capsules. Now known as Dexilant, dexlansoprazole is the proton pump inhibitor formerly known as Kapidex.

Key Points

FDA would like to alert healthcare providers to the recent proprietary name change for dexlansoprazole delayed-release capsules. Now known as Dexilant, dexlansoprazole is the proton pump inhibitor formerly known as Kapidex.

Since the product's approval on January 30, 2009, there have been several reports of proprietary name confusion between Kapidex and the products Casodex (bicalutamide tablets) and Kadian (morphine sulfate extended-release capsules).

Casodex is administered once daily and supplied as 50-mg tablets.

Casodex has greater name recognition, as it has been marketed for nearly 15 years for prostate cancer.

Although these products share the same route of administration and frequency of administration, they differ with regard to product strength, usual dose, and indication for use. Typically, these varying product characteristics provide differentiation to help prevent medication errors.

Additionally, Casodex is for use in men only; however, FDA received reports of women receiving this product in error.

There were also a few cases of reported name confusion between Kapidex and Kadian. In these cases, written prescriptions were received for Kapidex but Kadian was dispensed in error.

Although Kadian is a schedule II controlled substance indicated for moderate-to-severe pain, these products shared overlapping strengths of 30 mg and 60 mg, which may have increased the risk of confusion with this name pair.

Because of the product differences between these pharmaceuticals, FDA initially thought the errors were related to users' lack of familiarity with Kapidex and thus would rapidly decline as the product gained name recognition. However, the reports of confusion continued.

In cases in which the patient actually took the wrong medication, adverse events such as fatigue, flushing, or heart palpitations were reported. FDA was especially concerned by the inadvertent administration of Casodex to women, as it is contraindicated in women and has a pregnancy category X. Thus, in order to avoid future medication errors, the proprietary name of dexlansoprazole delayed-release capsules was changed to Dexilant.

Although there were no changes made to the dexlansoprazole delayed-release capsules other than to the name, healthcare professionals and other individuals responsible for ordering, stocking, and billing for the product should be aware that Dexilant has a new National Drug Code (NDC) number.

If you become aware of medication errors that involve Dexilant or any other medications, please report them to the FDA MedWatch program online at http://www.fda.gov/medwatch/.

DEVEONNE HAMILTON-STOKES, RN, BSN, is safety evaluator, Division of Medication Error Prevention and Analysis, Office of Surveillance and Epidemiology, FDA.

CAROL HOLQUIST, RPH, is director, Division of Medication Error Prevention and Analysis, Office of Surveillance and Epidemiology, FDA.