Dive Brief:
- Takeda’s antidepressant Brintellix will be marketed as Trintellix beginning in June, after the Food and Drug administration approved a brand name change in order to avoid confusion with AstraZeneca’s blood thinner Brilinta.
- The change was prompted by safety concerns laid out in a July 2015 MedWatch alert from the FDA, which reported name confusion between the two drugs had led to prescribing errors.
- Although the name will be changed, the drug will retain the same formulation, packaging, and labeling. Trintellix will get a new National Drug Code number, however.
Dive Insight:
Brilinta was approved in July 2011 to reduce the risk of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS).
Brintellix came on the market two years later in September 2013, indicated for treatment of major depressive disorder (MDD) in adults. As Brilinta was approved first, Takeda was responsible for changing Brintellix’s name once the safety concerns surrounding the two medications’ names became apparent
The FDA's Division of Medication Error Prevention and Analysis reviews the brand names of drugs prior to approval, and if the names are too similar they will require the company to select another name.
Brintellix’s name was fully screened before its U.S. launch, according to Takeda. But after consulting with the FDA over the name confusion reports, Takeda and Lundbeck agreed a name change would help reduce future risk for patients.
There is a long history of drug-name confusion leading to proprietary name changes. In 2005, Johnson & Johnson changed the name of its medication for mild-to-moderate Alzheimer's disease Reminyl to Razadyne in order to avoid confusion with the antidiabetic drug Amaryl (glimepiride). In some cases, Amaryl had been incorrectly dispensed to Alzheimer’s patients, leading to severe hypoglycemia in some and one death.
Even in the age of e-prescribing, handwritten prescriptions are still the norm for many. While the scientific names for drugs gives prescribers a distinct identifier, proprietary brand names can lead to some confusion.