From Brintellix to Trintellix : Drug's Name Changes for Safety

Megan Brooks

Disclosures

May 02, 2016

The US Food and Drug Administration (FDA) has approved a brand name change for the antidepressant Brintellix (vortioxetine, Takeda) to decrease the risk of prescribing and dispensing errors due to name confusion with the antiplatelet Brilinta (ticagrelor, AstraZeneca).

The new brand name for vortioxetine 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," the FDA said in a drug safety communication.

"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," the agency warned.

In a July 2015 MedWatch alert, the FDA reported that name confusion between Brintellix and Brilinta had led to 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," the agency said.

Vortioxetine is a serotonin reuptake inhibitor used to treat major depressive disorder in adults.

The FDA advises healthcare providers to carefully check to make sure they have prescribed or dispensed the correct medicine. "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," the agency said.

They also said individuals who order and stock 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," the FDA said.

Healthcare providers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

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