FDA: Confusion between names of breast cancer drugs may cause medication errors
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Incorrect use of the non-proprietary name for a newly approved breast cancer therapy in electronic medical record systems may cause confusion that results in medication errors, according to an FDA warning issued today.
Ado-trastuzumab emtansine, the FDA-approved nonproprietary name for Kadcyla (Genentech), should be used in all cases, according to the warning.
Some third-party publications, compendia references, health information systems and Internet sites drop the “ado” prefix and simply use trastuzumab emtansine. This can cause confusion with the drug trastuzumab (Herceptin, Genentech), according to FDA.
The dosing and treatment schedules for ado-trastuzumab emtansine and trastuzumab are different, and confusion between the two could lead to dosing errors that harm patients.
“Health care professionals should use both the FDA-approved proprietary name, Kadcyla, and its nonproprietary name (ado-trastuzumab emtansine) when communicating medication orders, on preprinted order sets and in computerized order entry systems,” the warning states. “Such redundancy may help to reduce the potential for medication errors. Additionally, strategies should be employed to warn against confusion between Kadcyla and Herceptin in medication-related computer systems.”
No medication errors linked to confusion between the two drugs have been reported since the FDA approved ado-trastuzumab emtansine in February. However, errors were reported in clinical trials of ado-trastuzumab emtansine before the drug was approved.
Ado-trastuzumab emtansine is approved for the treatment of metastatic HER-2–positive breast cancer in patients who have been treated with trastuzumab and a taxane-based therapy.