For those of you who have requested specific brand names from the FDA for your products and have had numerous names denied for reasons you cannot wrap you head around, take heart that FDA can make a mistake too. FDA reported today that there were at least 50 dispensing errors between two products that actually underwent the rigorous FDA name review process.
The two products according to the FDA”s Safety Communication (here) are:
- “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.” Brintellix was approved 9/30/13.
- “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.” Brilinta was approved 7/20/11.
The Agency notes that most of the confusion has resulted from the sound-alike and look-alike names of these two products. FDA also indicates that it has not had reports of patients being injured due to the potential dispensing errors; however, due to the differing nature of the two products, the chance exists for some pretty severe adverse events if the products are inappropriately dispensed.
So who is going to blink first? Will the FDA request one of the firms to change their product’s name, or one of the two firms move to change its name to avoid a potential error in dispensing? Or will FDA permit the status quo to persist, knowing the potential for this error to occur? Tough choices for the parties involved. Brillinta has been on the market for about two years longer than Brintelix. Had FDA recognized the look-alike and sound-alike nature of the names when it performed its initial name review for the latter product, it likely would not have approved the name. Do they then go back to the newer approved product and say, “Whoops, we goofed and need you to change your name”? According to the NDA summary documents, there was an acceptable name assessment prior to approval of the Brintellix.
Both are tablets; they have one overlapping color, but the available strengths are strikingly different (Brintellix comes in 5 mg [pink], 10 mg [yellow] 15 mg [orange], and 20 mg [red] tablets, while Brillinta is available only as a yellowish 90 mg tablet). It is possible that the best way to resolve the issue is to make prescribers aware of the potential confusion and make certain that prescribers and dispensers key off of the strengths. Let’s keep an eye on this and see how the FDA and the firms proceed.