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Regulatory News | 02 May 2016 | By Zachary Brennan
The US Food and Drug Administration (FDA) on Monday approved a brand name change for Takeda’s antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from confusion with AstraZeneca’s blood-thinning medicine Brilinta (ticagrelor).
The new brand name of Brintellix will be Trintellix, and the tablets will look nearly identical and are expected to be available in June, FDA said.
“No other changes will be made to the label or packaging, and the medicine is exactly the same,” the agency wrote. “During the transition to the new name change from Brintellix to Trintellix, prescribers can reduce the risk of name confusion by including the generic name of the medication they are ordering, in addition to the brand name and indication for use,” FDA says.
However, due to the lag time associated with manufacturing bottles with the new brand name, health care professionals and patients may continue to see bottles labeled with the brand name Brintellix during the transition period, FDA said.
The name change follows a July 2015 MedWatch alert in which FDA warned that name confusion between Brintellix and Brilinta had resulted in 50 reports of prescribing and dispensing errors since Brintellix was first approved in September 2013.
The agency says 12 of the reports resulted in a patient being given the wrong drug; however, none of the reports indicate that a patient actually consumed the wrong drug.
FDA recommends that health professionals carefully check to make sure they have prescribed or dispensed the correct medicine. Individuals responsible for ordering and stocking the medicine should be aware that Trintellix will have a new National Drug Code (NDC) number.
FDA has previously had issues with non-proprietary name confusion and issues with too many drugs starting with the letter “X” and “Z”.
Brintellix (vortioxetine): Drug Safety Communication - Brand Name Change to Trintellix, to Avoid Confusion With Antiplatelet Drug Brilinta (ticagrelor)
Tags: brand name change, medication errors, Brinellix, Brilinta