Ticagrelor (Brilinta®) and Vortioxetine (Brintellix®) Brand Name Confusion – Vortioxetine Brand Name Changed from Brintellix® to Trintellix®
May 10, 2016
FDA has approved the brand name change of vortioxetine from Brintellix® to Trintellix®, due to name confusion with ticagrelor (Brilinta®). A total of 55 cases of name confusion have been reported to FDA. Vortioxetine is a selective serotonin reuptake inhibitor labeled to treat major depressive disorder in adults. Ticagrelor is an antiplatelet medication used to reduce the risk of certain blood clot-related events (eg, heart attack) in patients with cardiovascular disorders such as unstable angina or a prior heart attack.
In 12 of the 50 reports FDA received by July 2015, the wrong medication was dispensed to the patient. The source of the error for half of the 12 reports occurred when prescribing the medication, while the source was during dispensing for the remaining half. Computerized physician order entry (CPOE) may have contributed to 5 of the 6 errors made during prescribing, since some CPOE systems autopopulate after the first 3 letters of the drug name are typed.
FDA received 5 additional reports between July 2015 and May 2016. Two of these cases involved a serious adverse drug event. In one case, medical staff thought a patient was taking Brintellix, but the patients was actually taking Brilinta. The patient underwent a lung biopsy and suffered a bleeding event and collapsed lung. The second patient was dispensed Brintellix instead of Brilinta. The patient suffered a fall, possibly due to dizziness associated with Brintellix, and required hospitalization.
Brand name Trintellix® (vortioxetine) will be available in June 2016. Vortioxetine stock may be available under both brand names (ie, Brintellix and Trintellix) during the transition period, due to lag times in manufacturing. The Trintellix labeling, package insert, and tablet features will not change beyond the brand name and new NDC. Prescribers should include the generic name of the medication and the indication when prescribing either ticagrelor or vortioxetine to help avoid confusion. Patients should check dispensed medication to verify the correct medication was provided. Both medications are currently available as brand name products, only. Use the following tablet identification information to help verify the correct dispensed medication:
- Trintellix®/Brintellix® tablets are tear-shaped
- 5 mg tablets – pink with “TL” on one side and “5” on the reverse
- 10 mg tablets – yellow with “TL” on one side and “10” on the reverse
- 15 mg tablets – orange with “TL” on one side and “15” on the reverse
- 20 mg tablets – red with “TL” on one side and “20” on the reverse
- Brilinta® tablets are round
- 60 mg tablets – pink with a “60” above “T” on one side
- 90 mg tablets – yellow with a “90” above “T” on one side
- Drug Safety Communication – May 2, 2016 (Updated from July 30, 2015)
- MedWatch Safety Alert – July 30, 2015
May 10, 2016, July 31 2015; University of Utah, Drug Information Service. Copyright 2016, Drug Information Service, University of Utah, Salt Lake City, UT.