Drug Renamed to Prevent Medication Errors
To reduce the chance for mixup, FDA has approved changing the name of the heartburn drug dexlansoprazole from Kapidex to Dexilant. This new name aims to avoid confusion with two other medications, Casodex and Kadian. Takeda Pharmaceuticals North America Inc. will begin marketing the drug under the new name in late April 2010.
According to FDA, since Kapidex was approved in January 2009, there have been reports of dispensing errors because of confusion with the drugs Casodex (bicalutamide) and Kadian (morphine sulfate), which have very different uses from Kapidex and from each other.
"Kapidex is a proton pump inhibitor used to treat heartburn and other conditions by reducing the amount of acid produced in the stomach. Casodex, marketed by AstraZeneca, is used to treat men with advanced prostate cancer. Kadian, distributed by Actavis Kadian LLC, is an opioid analgesic used to treat pain," FDA states on its Web site.
“FDA is pleased to have worked with Takeda to take swift and responsible steps to change the name of this product in the interest of patient safety,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
There will be no other changes to Kapidex other than its new name.
FDA does evaluate new drug names before product approval, but the agency is stepping up its precess with a new guidance for industry, "Contents of a Complete Submission for the Evaluation of Proprietary Names." The guidance explains what information should be submitted to help in the evaluation of a proposed proprietary drug or biologic name, and to ensure compliance with other requirements for labeling and promotion.
The agency reports that the new guidance is part of its Safe Use Initiative. Launched in November 2009, the initiative aims to reduce preventable medical errors.