FDA issues warning about shortened cancer drug name
Whats in a name? A lot, according to a new warning from the Food and Drug Administration (FDA).
May 07, 2013 at 06:00 AM
2 minute read
The original version of this story was published on Law.com
What's in a name? A lot, according to a new warning from the Food and Drug Administration (FDA).
The agency on Monday alerted the public that using a shorter name for the new breast cancer drug Kadcyla may lead to confusion with another treatment. Kadcyla, which is manufactured by a subsidiary of the Roche group, is properly known as ado-trastuzumab emtansine. This is similar to another Roche drug, the breast cancer therapy Herceptin, which is generically known as trastuzumab.
Mix-ups between the two drugs would be problematic, the FDA said, because the medications have very different dosing and treatment schedules. To prevent this, the agency advised medical professionals to use both Kadcyla's brand name and generic name in treatment orders and medical records.
Several medication errors were reported during clinical trials for the drug; however, the FDA did note that no such confusion is known to have occurred since Kadcyla was approved on Feb. 22.
Roche told Thomson Reuters that it has designed new packaging for Kadcyla to distinguish it from Herceptin, and that it tacked had previously tacked the “ado” prefix onto the drug at the FDA's request.
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