Name Change For Takeda's Dexilant Shows Challenge Of Pre-Market Screening
Executive Summary
Sometime after Takeda released its heartburn treatment dexlansoprazole onto the U.S. market in January 2009, it noticed something strange in its post-marketing surveillance: the number of medication errors reported for the drug was not going down
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Regulatory News In Brief
Takeda heartburn drug gets name change: Takeda's proton pump inhibitor Kapidex (dexlansoprazole) will be marketed under a new brand name, Dexilant, starting in late April, in order to prevent confusion with two very dissimilar drugs with potentially similar names, the company and FDA announced March 4. FDA said it approved the name change to avoid confusion with AstraZeneca's prostate cancer treatment Casodex (bicalutamide) and Actavis' Kadian (morphine sulfate), an opiate pain reliever. Kapidex was approved in January 2009, and FDA said there have been reports of dispensing errors with the other two drugs since then, although neither the agency nor the company gave any details. The agency highlighted the change as a success for its Safe Use Initiative, which it began in November 2009 (1"The Pink Sheet" DAILY, Nov. 4, 2009). In a similar incident involving an OTC drug, FDA has asked Novartis to rebrand a Maalox line extension, Maalox Total Relief, a stomachache/diarrhea remedy. The agency said it received "five reports of serious medication errors involving consumers" that accidentally used Total Relief in place of the regular Maalox antacid products (2"The Tan Sheet," Feb. 22, 2010)