Clinical trials show drug is effective in treating depression and preventing future episodes
TUESDAY, Oct. 1 (HealthDay News) -- Brintellix (vortioxetine) has been approved by the U.S. Food and Drug Administration to treat adults with major depressive disorder.
In seven clinical studies, Brintellix proved effective in treating depression and in preventing future episodes, the FDA said in a news release. The most common side effects observed included nausea, constipation, and vomiting.
Brintellix has a boxed label warning that antidepressants can raise the risk of suicidal thoughts among some users, especially among children, adolescents, and adults aged 18 to 24. Doctors should carefully monitor users of Brintellix and similar drugs, especially during initial treatment, the FDA advised.
Brintellix is marketed by Takeda Pharmaceuticals and Lundbeck, both based in Deerfield, Ill.
More Information (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm370416.htm )