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FDA Approves Brand Name Change for Brintellix (vortioxetine)

By FDA MedWatch | May 3, 2016

Brintellix (vortioxetine): Drug Safety Communication – Brand Name Change to Trintellix, to Avoid Confusion With Antiplatelet Drug Brilinta (ticagrelor)

ISSUE: 

FDA has approved a brand name change for the antidepressant Brintellix (vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (ticagrelor). The new brand name of the drug will be Trintellix, and it is expected to be available starting in June 2016. No other changes will be made to the label or packaging, and the medicine is exactly the same.

Because of 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.

In a July 2015 MedWatch Alert, FDA warned that name confusion between Brintellix and Brilinta had resulted in prescribing and dispensing errors since Brintellix was approved in September 2013. Due to continued reports of name confusion between the two medicines used for very different purposes, FDA worked with Brintellix manufacturer Takeda Pharmaceuticals to change the drug’s brand name.

BACKGROUND:

Brintellix/Trintellix (vortioxetine) is used to treat a certain type of depression called major depressive disorder in adults. It is in a class of antidepressants called serotonin reuptake inhibitors (SSRIs) that work by affecting chemicals in the brain that may become unbalanced.

RECOMMENDATION: 

Individuals responsible for ordering and stocking the medicine should be aware that Trintellix will have a new National Drug Code (NDC) number. It is important for drug information content publishers and medication-related electronic system administrators to use the new brand name Trintellix and NDC number once Takeda makes vortioxetine available under the new name Trintellix.

Click here to read the MedWatch safety alert, including a link to the FDA Drug Safety Communication.

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