vortioxetine FDA Alerts
The FDA Alert(s) below may be specifically about vortioxetine or relate to a group or class of drugs which include vortioxetine.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for vortioxetine
Brintellix (vortioxetine): Drug Safety Communication - Brand Name Change to Trintellix, to Avoid Confusion With Antiplatelet Drug Brilinta (ticagrelor)
May 2, 2016
Audience: Psychiatry, Internal Medicine, Pharmacy
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: Health care professionals should check carefully 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. Patients should make sure they have received the correct medicine. Trintellix tablets will look the same as the Brintellix tablets. Those having any questions or concerns should talk to their prescriber or pharmacist.
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.
Healthcare professionals and patients 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:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[05/02/2016 - Drug Safety Communication - FDA]