Brintellix Name Change
May 2, 2016 – The U.S. Food and Drug Administration (FDA) has given Takeda Pharmaceuticals and Lundbeck Pharmaceuticals approval to change the brand name of their antidepressant, Brintellix® (vortioxetine) which has been involved in more than 50 prescribing and dispensing mix-ups that have been reported since Brintellix was introduced in September 2013. Brintellix is often confused with Brilinta® (ticagrelor) manufactured by AstraZeneca and indicated to prevent heart attacks and strokes for patients who have acute coronary syndrome or who previously have had a heart attack, To end confusion between the similar names, Brintellix is being re-named Trintellix. It will look the same – pink (5mg), yellow (10mg) or orange (20mg) tear-drop-shaped tablets. Additionally, directions for its use will not change. Beginning in June, bottles of newly manufactured tablets will be labeled with the new brand name and a new National Drug Code (NDC) number assigned by FDA. For a few months, pharmacies may have bottles with both brand names in stock. Brilinta will continue to be made as round, yellow tablets imprinted with “90” and a “T”. To assure that the drug is correct, FDA advises prescribers to include the generic name of the drug and the condition it is being used to treat on the prescription form or electronic transmission.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.