FDA Warns about Confusion Regarding Breast Cancer Drug

FDA Warns about Confusion Regarding Breast Cancer Drug

FDA Warns about Confusion Regarding Breast Cancer Drug

The Office on Women’s Health (OWH) sent this bulletin at 05/13/2013 05:11 PM EDT

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FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla The U.S. Food and Drug Administration (FDA) is alerting health care professionals that the use of the incorrect nonproprietary name for the breast cancer drug Kadcyla (ado-trastuzumab emtansine) in some medication-related electronic systems poses a risk of mix-up with Herceptin (trastuzumab) and may result in medication errors. The dosing and treatment schedules for Kadcyla and Herceptin, another breast cancer drug, are quite different, so confusion between these products could lead to dosing errors and potential harm to patients. The FDA-approved nonproprietary name for Kadcyla, ado-trastuzumab emtansine, should be used. However, some third-party publications, compendia references, health information systems (e.g., electronic health record systems and systems used for pharmacy prescription processing, wholesaler ordering, pharmacy ordering, etc.), and sites on the Internet are incorrectly using the United States Adopted Name (USAN), which is “trastuzumab emtansine,” and omitting the “ado” prefix and hyphen. Use of this truncated version of Kadcyla’s nonproprietary name may cause confusion with Herceptin (trastuzumab). Health care professionals should use both the FDA-approved proprietary (brand) name Kadcyla and its nonproprietary name (ado-trastuzumab emtansine) when communicating medication orders, on preprinted order sets, and in computerized order entry systems. Such redundancy may help to reduce the potential for medication errors. Additionally, strategies should be employed to warn against confusion between Kadcyla (ado-trastuzumab emtansine) and Herceptin (trastuzumab) in medication-related computer systems. It is important for drug information content publishers to identify drug products by the FDA-approved proprietary (brand) and nonproprietary names that are used in FDA-approved drug labels. This will help prevent medication errors and ensure adverse events are reported for the correct product. No medication errors related to confusion between Kadcyla and Herceptin have been reported to FDA since approval of Kadcyla on February 22, 2013; however medication errors did occur during the clinical trials that evaluated its safety and efficacy prior to approval. More information is available here.