FDA Drug Safety Communication

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FDA Date: 7/30/15

Brintellix (vortioxetine) and Brilinta (ticagrelor) FDA Drug Safety Communication

FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor)

The U.S. Food and Drug Administration is warning health care professionals and patients that reports of confusion between the antidepressant Brintellix and anti-blood clotting medication Brilinta have resulted in the wrong medication being prescribed or dispensed. We have determined that the main reason for the confusion between these two medications is the similarity of their brand (proprietary) names. None of the reports indicates that a patient ingested the wrong medication; however, reports of prescribing and dispensing errors continue. As a result, we are alerting the public about this safety issue.

Health care professionals can reduce the risk of name confusion by including the generic (established) name of the medication, in addition to the brand name, and the indication for use when prescribing these medications. Patients should check their prescriptions to ensure that the correct medication was dispensed.

Brintellix (vortioxetine) is used to treat a certain type of depression called major depressive disorder (MDD) in adults. It is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs) that work by affecting chemicals in the brain that may become unbalanced. Brintellix is a tear-shaped tablet stamped with "TL" on one side of the tablet and a number that indicates the tablet strength on the other side. It varies in color depending upon the strength prescribed.

Brilinta (ticagrelor) is an antiplatelet, anti-blood clotting medication used to lower the risk of having another heart attack, or dying from a heart problem after a heart attack or severe chest pain. It works by keeping the platelets in the blood from sticking together, thereby preventing blood clots that can occur with certain heart conditions. Brilinta is a round, yellow tablet with a "90" above a "T" stamped on one side.

As of June 2015, FDA has received 50 reports of medication error cases describing brand name confusion with Brintellix and Brilinta. Most of the cases reported concerns that similarities in the sound, look, or both sound and look of the two brand names could cause confusion for prescribers and pharmacists. Some cases resulted in the wrong medication being dispensed to a patient. In one case, a pharmacist misinterpreted Brintellix as Brilinta and did not dispense any medication because the patient had a contraindication to blood thinners.

View the full FDA Drug Safety Communication on FDA.gov