Drugs

FDA Drug Safety Podcast: FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor)

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Welcome to FDA Drug Safety Podcasts for health care professionals. This is Lesley Navin, Advanced Practice Nurse from the Division of Drug Information.

On May 2, 2016, FDA announced it has approved a brand name change for the antidepressant Brintellix (active ingredient vortioxetine) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (active ingredient 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.

Health care professionals should check carefully to make sure that 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.

Brintellix/Trintellix (active ingredient 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.

In a July 2015 Drug Safety Communication, we 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, FDA worked with Brintellix manufacturer Takeda Pharmaceuticals to change the drug’s brand name.

Individuals responsible for ordering and stocking the medicine should be aware that Trintellix will have a new National Drug Code (or 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.

Name confusion, medication errors, and any side effects involving Brintellix/Trintellix or Brilinta should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication including the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

And follow us on Twitter @FDA_Drug_Infodisclaimer icon for up to the minute important drug information. Thank you for listening.

Page Last Updated: 05/06/2016
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