Antidepressant to Be Renamed After Serious Errors Reported
The name change is following reports of name confusion in the marketplace between Brintellix and Brilinta (ticagrelor; AstraZeneca), an antiplatelet medication. The manufacturers and the Food and Drug Administration (FDA) decided that a name change would be best to prevent future name confusion among patients and clinicians.
In July 2015, The FDA had warned about how the name confusion between Brintellix and Brilinta led to prescribing and dispensing errors since September 2013. Since that safety communication, the FDA has identified five additional cases involving brand name confusion between the two drugs; a total of 55 cases have now been reported. Two of the five recent cases led to serious adverse drug events: one patient had bleeding and partial collapse of a lung following a lung biopsy after receiving Brilinta instead of Brintellix; another patient experienced a fall and was hospitalized after ingesting Brintellix instead of Brilinta.
The formulation, indication, and dosage strengths (5mg, 10mg, 15mg, 20mg) of Trintellix will remain the same as that of Brintellix. With the name transition this summer, healthcare providers can still prescribe the product under the current name, Brintellix. The new Trintellix product will be accessible starting June 2016 and its tablet markings will be identical to the markings on tablets before the name change. Trintellix will be designated a new National Drug Code (NDC) number.
Brintellix is indicated for the treatment of major depressive disorder (MDD) in adults. It is an inhibitor of serotonin (5-HT) reuptake and that is thought to be a mechanism of its action. It is also an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors and an antagonist at 5-HT3, 5-HT1D and 5-HT7 receptors.